protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT02842086 | 7 | ADVERSE EVENTS AND TOXICITY MANAGEMENT | 7. ADVERSE EVENTS AND TOXICITY MANAGEMENT | [] |
NCT02842086 | 7.1 | Definitions of Adverse Events, Adverse Reactions, and Serious Adverse Events | 7.1. Definitions of Adverse Events, Adverse Reactions, and Serious Adverse Events | [] |
NCT02842086 | 7.1.1 | Adverse Events | 7.1.1. Adverse Events An AE is any untoward medical occurrence in a clinical study participant administered a study drug, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a s... | [] |
NCT02842086 | 7.1.2 | Serious Adverse Events | 7.1.2. Serious Adverse Events An SAE is defined as an event that, at any dose, results in the following: - Death - A life-threatening situation (Note: The term "life-threatening" in the definition of "serious" refers to an event in which the participant was at risk of death at the time of the event; it does not refer t... | [] |
NCT02842086 | 7.1.3 | Clinical Laboratory Abnormalities and Other Abnormal Assessments as Adverse Events or Serious Adverse Events | 7.1.3. Clinical Laboratory Abnormalities and Other Abnormal Assessments as Adverse Events or Serious Adverse Events Laboratory abnormalities without clinical significance are not recorded as AEs or SAEs. However, laboratory abnormalities (eg, clinical chemistry, hematology, and urinalysis) that require medical or surgi... | [] |
NCT02842086 | 7.2 | Assessment of Adverse Events and Serious Adverse Events | 7.2. Assessment of Adverse Events and Serious Adverse Events The investigator or qualified subinvestigator is responsible for assessing AEs and SAEs for causality and severity, and for final review and confirmation of accuracy of event information and assessments. | [] |
NCT02842086 | 7.2.1 | Assessment of Causality for Study Drugs and Procedures | 7.2.1. Assessment of Causality for Study Drugs and Procedures The investigator or qualified subinvestigator is responsible for assessing the relationship to study drug using clinical judgment and the following considerations: - No: Evidence exists that the adverse event has an etiology other than the study drug. For SA... | [] |
NCT02842086 | 7.2.2 | Assessment of Severity | 7.2.2. Assessment of Severity Severity should be recorded and graded according to the Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities ([Appendix 5](#page-106-0)). For AEs associated with laboratory abnormalities, the event should be graded on the basis of the clinical severity in the co... | [] |
NCT02842086 | 7.3 | Investigator Requirements and Instructions for Reporting Adverse Events and Serious Adverse Events to Gilead | 7.3. Investigator Requirements and Instructions for Reporting Adverse Events and Serious Adverse Events to Gilead | [] |
NCT02842086 | 7.3.1 | Requirements for Collection Prior to Study Drug Initiation: | 7.3.1. Requirements for Collection Prior to Study Drug Initiation: Prior treatment history is collected as part of the study entry criteria and evaluation of individual patient characteristics and will not be generating lack of effect reports as this is outside the scope of the present clinical study. However, investig... | [] |
NCT02842086 | 7.3.2 | Adverse Events | 7.3.2. Adverse Events Following initiation of study medication, collect all AEs, regardless of cause or relationship, until 30 days after last administration of study drug must be reported to the eCRF database as instructed. All AEs should be followed until resolution or until the adverse event is stable. Gilead may re... | [] |
NCT02842086 | 7.3.3 | Serious Adverse Events | 7.3.3. Serious Adverse Events All SAEs, regardless of cause or relationship, that occur after the participant first consents to paiiicipate in the study (ie, signing the ICF) and throughout the duration of the study, including the protocol-required posttr·eatment follow-up period, must be repo1ied on the applicable eCR... | [] |
NCT02842086 | 7.3.3.1 | Elech'onic Serious Adverse Event ( eSAE) Repo1iing Process | 7.3.3.1. Elech'onic Serious Adverse Event ( eSAE) Repo1iing Process - Site personnel will record all SAE data in the eCRF database and from there tr·ansmit the SAE info1mation to Gilead GLPS within 24 hours of the investigator's knowledge of the event from ICF signature throughout the duration of the study, including t... | [] |
NCT02842086 | 7.4 | Gilead Reporting Requirements | 7.4. Gilead Reporting Requirements Depending on relevant local legislation or regulations, including the applicable US FDA Code of Federal Regulations, the EU Clinical Trials Directive (2001/20/EC) and relevant updates, and other country-specific legislation or regulations, Gilead may be required to expedite to worldwi... | [] |
NCT02842086 | 7.5 | Special Situations | 7.5. Special Situations Special situation reports include reports of medication error, abuse, misuse, or overdose, occupational exposure with an AE, and reports of adverse reactions associated with product complaints. Medication error is any preventable event that can cause or lead to inappropriate medication use or pa... | [] |
NCT02842086 | 7.5.1 | Reporting Special Situations | 7.5.1. Reporting Special Situations
Elect:I-onic Special Situations Rep01ting - Site personnel record all special situations data in the eCRF database and from there tr·ansmit the special situations infonnation to Gilead GLPS within 24 hours of the investigator's knowledge of the event. Detailed instructions can be fo... | [
"Elect:I-onic Special Situations Rep01ting"
] |
NCT02842086 | 7.6 | Toxicity Management | 7.6. Toxicity Management All clinical and clinically significant laboratory toxicities will be managed according to uniform guidelines detailed in [Appendix 4](#page-105-0) as outlined below. - All clinically significant Grade 3 and 4 laboratory abnormalities should be repeated within 3 calendar days to confirm toxicit... | [] |
NCT02842086 | 7.6.1 | Grades 1 and 2 Laboratory Abnormality or Clinical Event | 7.6.1. Grades 1 and 2 Laboratory Abnormality or Clinical Event Continue study drug at the discretion of the investigator. | [] |
NCT02842086 | 7.6.2 | Grades 3 Laboratory Abnormality or Clinical Event | 7.6.2. Grades 3 Laboratory Abnormality or Clinical Event - For Grade 3 clinically significant laboratory abnormality or clinical event, study drug may be continued if the event is considered to be unrelated to study drug. - For a Grade 3 clinical event, or clinically significant laboratory abnormality confirmed by repe... | [] |
NCT02842086 | 7.6.3 | Grade 4 Laboratory Abnormality or Clinical Event | 7.6.3. Grade 4 Laboratory Abnormality or Clinical Event For a Grade 4 clinical event or clinically significant Grade 4 laboratory abnormality confirmed by repeat testing that is considered related to study drug, study drug should be permanently discontinued and the participant managed according to local practice. The p... | [] |
NCT02842086 | 7.6.4 | Management of Bone Evaluation | 7.6.4. Management of Bone Evaluation As there may be uncertainty surrounding the clinical significance and management of decreases in BMD, Gilead recommends that any participant who has a DXA scan that demonstrates a decrease from baseline of > 5% in the spine region or > 7% in the hip region be followed per local medi... | [] |
NCT02842086 | 7.6.5 | Management of Changes in Estimated Glomerular Filtration Rate | 7.6.5. Management of Changes in Estimated Glomerular Filtration Rate Estimated GFR, according to the Cockcroft-Gault formula, will be followed postbaseline during the study. All participants with eGFR < 60 mL/min must have serum creatinine and participant's weight measured again within 3 calendar days of receipt of res... | [] |
NCT02842086 | 7.6.6 | Potential High-Risk Exposure | 7.6.6. Potential High-Risk Exposure For participants who present after a high-risk sexual exposure, were non-adherent to study drug, and request PEP, investigators may discontinue the participant's study medication and provide PEP in accordance with local medical practice and/or guidelines. Participants who complete th... | [
"8- STATISTICAL CONSIDERATIONS"
] |
NCT02842086 | 8.1 | Analysis Objectives and Endpoints | 8.1. Analysis Objectives and Endpoints | [] |
NCT02842086 | 8.1.1 | Analysis Objectives | 8.1.1. Analysis Objectives The prirmuy objective of this study is: • To assess the rates of HIV-I infection in MSM and TGW who have sex with men who are administered daily F/TAF or F/TDF with a minimum follow up of 48 weeks and at least 50% of paiiicipants have 96 weeks of follow up after randomization The secondaiy ob... | [] |
NCT02842086 | 8.1.2 | Primary Endpoints | 8.1.2. Primary Endpoints The primary endpoint will be the incidence of HIV-1 infection per 100 PY when all participants have a minimum follow up of 48 weeks and at least 50% of the participants have 96 weeks of follow up after randomization. HIV-1 infection is defined by one or more of the following criteria of contrib... | [] |
NCT02842086 | 8.1.3 | Secondary Endpoints | 8.1.3. Secondary Endpoints The key (α-controlled) secondary endpoints in the blinded phase are (in the following order): - The percent change from baseline in hip BMD at Week 48 in a subset of participants - The percent change from baseline in spine BMD at Week 48 in a subset of participants - Assessment of renal bioma... | [] |
NCT02842086 | 8.2 | Analysis Conventions | 8.2. Analysis Conventions | [] |
NCT02842086 | 8.2.1 | Analysis Sets | 8.2.1. Analysis Sets | [] |
NCT02842086 | 8.2.1.1 | Randomized Analysis Set | 8.2.1.1. Randomized Analysis Set Paiiicipants that ai·e randomized into the study will be included in this analysis set. This is the primaiy analysis set for by-paiiicipant listings. | [] |
NCT02842086 | 8.2.1.2 | Full Analysis Set (FAS) | 8.2.1.2. Full Analysis Set (FAS) The FAS will include all the participants who randomize and receive at least one dose of study diug. The FAS will exclude paiiicipants with major protocol violations ( eg, HIV-1 positive at baseline). The FAS analysis set is the prima1y analysis set for the efficacy endpoints. | [] |
NCT02842086 | 8.2.1.3 | Per Protocol (PP) Analysis Set | 8.2.1.3. Per Protocol (PP) Analysis Set The PP analysis set will include all paiiicipants who (1) randomize into the study, (2) receive at least one dose of study diug, and (3) have not committed any major protocol violation, including the violation of key entiy criteria. Paiiicipants meeting any of the following crite... | [] |
NCT02842086 | 8.2.1.4 | Safety Analysis Set | 8.2.1.4. Safety Analysis Set The prima1y analysis set for safety analyses is defined as all pa1iicipants who randomize in to the study and received at least one dose of study diug. | [] |
NCT02842086 | 8.2.1.5 | Hip DXA Analysis Set | 8.2.1.5. Hip DXA Analysis Set The Hip DXA analysis set will include all paiiicipants who randomize and receive at least one dose of study diug, had nonmissing hip BMD value for the baseline visit and at least one postbaseline visit. Paiiicipants will be grouped according to the ti·eatment they actually received. | [] |
NCT02842086 | 8.2.1.6 | Spine DXA Analysis Set | 8.2.1.6. Spine DXA Analysis Set The Spine DXA analysis set will include all paiiicipants who randomize and receive at least one dose of study diug, and had nonmissing spine BMD value for the baseline visit and at least one postbaseline visit. Paiiicipants will be grouped according to the ti·eatment they actually receiv... | [] |
NCT02842086 | 8.3 | Demographic Data and Baseline Characteristics | 8.3. Demographic Data and Baseline Characteristics Demographic and baseline measurements will be summarized using standard descriptive methods. Demographic summaries will include sex, race/ethnicity, and age. Baseline data will include a summaiy of body weight, height and body mass index, number of sexual paitners in t... | [] |
NCT02842086 | 8.4 | Efficacy Analysis | 8.4. Efficacy Analysis | [] |
NCT02842086 | 8.4.1 | Primary Analysis | 8.4.1. Primary Analysis The primaiy endpoint will be the incidence of HIV-1 infection per 100 PY (HIV-1 infection defined by the HIV Infection Endpoint Definition in [Appendix 7\)](#page-129-0). The timing of the primaiy analysis will occur when the last pa1ticipant has a minimum of 48 weeks of follow up and at least 5... | [] |
NCT02842086 | 8.4.2 | Secondary Efficacy Analysis | 8.4.2. Secondary Efficacy Analysis A similai· analysis to the prima1y analysis, when all pa1ticipants have 96 weeks of follow up after randomization will be conducted. Similai· incidence rates and Cis will be repo1ted for the extended follow up time. | [] |
NCT02842086 | 8.5 | Safety Analysis | 8.5. Safety Analysis All safety analyses will be perfo1m ed using the safety analysis set. All safety data collected on or after the date that study medication was first dispensed up to the date of last dose of study medication plus 30 days will be summarized by treatment group. Data for the pretreatment and treatment-... | [] |
NCT02842086 | 8.5.1 | Extent of Exposure | 8.5.1. Extent of Exposure A participant's extent of exposure to study medication will be generated from the study medication administration data. Exposure data will be summarized by treatment group. Duration of exposure to study drug will be expressed as the number of weeks between the first and last dose of the study ... | [] |
NCT02842086 | 8.5.2 | Adverse Events | 8.5.2. Adverse Events Clinical and laboratory AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). System Organ Class (SOC), High-Level Group Term (HLGT), High-Level Term (HLT), Preferred Term (PT), and Lower-Level Term (LLT) will be attached to the clinical database. Events will be summar... | [] |
NCT02842086 | 8.5.3 | Laboratory Evaluations | 8.5.3. Laboratory Evaluations Selected laboratory data will be summarized using only observed data. Absolute values and changes from baseline at all scheduled time points will be summarized. Graded laboratory abnormalities will be defined using the Gilead Grading Scale for Severity of Adverse Events and Laboratory Abno... | [] |
NCT02842086 | 8.5.6 | Other Safety Evaluations | 8.5.6. Other Safety Evaluations Weight will be summarized by visit. | [] |
NCT02842086 | 8.6 | Statistical Testing Procedure | 8.6. Statistical Testing Procedure The prima1y hypothesis of non-inferiority ofF/TAF relative to F/TDF, with respect to the incidence of HIV-1 infection rate per 100 PY will be tested first. Non-inferiority test will be perfo1med at one-sided, 0.025 alpha level. Multiplicity adjustments for safety endpoints will be per... | [] |
NCT02842086 | 8.8 | Sample Size | 8.8. Sample Size A sample size of 2500 in each aim (1: 1 randomization) provides at least 82% power to show F/TAF is non-inferior to F/TDF with respect to the HIV-I infection rate. In this power analysis, a HIV-I infection rate of 1.44 per 100 PY in the FIT AF and F /TDF treatment aims, a 2-sided Type 1 enor rate of 5%... | [] |
NCT02842086 | 8.9 | Data Monitoring Committee | 8.9. Data Monitoring Committee An independent data monitoring committee (IDMC) will be convened to primarily evaluate the safety of the treatments in this population. There are no a priori plans to stop for efficacy or futility with formal boundaries. At a minimum, the IDMC will include 2 clinicians (including a chairp... | [] |
NCT02842086 | 9 | RESPONSIBILITIES | 9. RESPONSIBILITIES | [] |
NCT02842086 | 9.1 | Investigator Responsibilities | 9.1. Investigator Responsibilities | [] |
NCT02842086 | 9.1.1 | Good Clinical Practice | 9.1.1. Good Clinical Practice The investigator will ensure that this study is conducted in accordance with the principles of the Declaration of Helsinki (as amended in Edinburgh, Tokyo, Venice, Hong Kong, and South Africa), ICH guidelines, or with the laws and regulations of the country in which the research is conduct... | [] |
NCT02842086 | 9.1.2 | Institutional Review Board (IRB)/Independent Ethics Committee (IEC) Review and Approval | 9.1.2. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) Review and Approval The investigator (or sponsor as appropriate according to local regulations) will submit this protocol, ICF, and any accompanying material to be provided to the participant (such as advertisements, participant information shee... | [] |
NCT02842086 | 9.1.3 | Informed Consent | 9.1.3. Informed Consent The investigator is responsible for obtaining written informed consent from each individual participating in this study after adequate explanation of the aims, methods, objectives, and potential hazards of the study and before undertaking any study-related procedures. The investigator must use t... | [] |
NCT02842086 | 9.1.4 | Confidentiality | 9.1.4. Confidentiality The investigator must assure that participants' anonymity will be strictly maintained and that their identities are protected from unauthorized parties. Only participant initials, date of birth, another unique identifier (as allowed by local law) and an identification code will be recorded on any... | [] |
NCT02842086 | 9.1.5 | Study Files and Retention of Records | 9.1.5. Study Files and Retention of Records The investigator must maintain adequate and accurate records to enable the conduct of the study to be fully documented and the study data to be subsequently verified. These documents should be classified into at least the following 2 categories: (1) investigator's study file,... | [] |
NCT02842086 | 9.1.6 | Case Report Forms | 9.1.6. Case Report Forms An eCRF casebook will be completed by an authorized study personnel member whose training for this function is completed in the electronic data capture (EDC) system unless otherwise directed. The eCRF casebook will only capture the data required per the protocol schedule of events and procedure... | [] |
NCT02842086 | 9.1.7 | Investigational Medicinal Product Accountability and Return | 9.1.7. Investigational Medicinal Product Accountability and Return The study monitor will provide instructions for return to the designated disposal site. If return is not possible, the study monitor will evaluate each study center's study drug disposal procedures and provide appropriate instruction for destruction of ... | [] |
NCT02842086 | 9.1.8 | Inspections | 9.1.8. Inspections The investigator will make available all source documents and other records for this study to Gilead's appointed study monitors, to IRBs/IECs, or to regulatory authority or health authority inspectors. | [] |
NCT02842086 | 9.1.9 | Protocol Compliance | 9.1.9. Protocol Compliance The investigator is responsible for ensuring the study is conducted in accordance with the procedures and evaluations described in this protocol. | [] |
NCT02842086 | 9.2 | Sponsor Responsibilities | 9.2. Sponsor Responsibilities | [] |
NCT02842086 | 9.2.1 | Protocol Modifications | 9.2.1. Protocol Modifications Protocol modifications, except those intended to reduce immediate risk to study participants, may be made only by Gilead. The investigator must submit all protocol modifications to the IRB/IEC in accordance with local requirements and receive documented IRB/IEC approval before modification... | [] |
NCT02842086 | 9.2.2 | Study Report and Publications | 9.2.2. Study Report and Publications A clinical study report (CSR) will be prepared and provided to the regulatory agency(ies). Gilead will ensure that the report meets the standards set out in the ICH Guideline for Structure and Content of Clinical Study Reports (ICH E3). Note that an abbreviated report may be prepare... | [] |
NCT02842086 | 9.3 | Joint Investigator/Sponsor Responsibilities | 9.3. Joint Investigator/Sponsor Responsibilities | [] |
NCT02842086 | 9.3.1 | Payment Reporting | 9.3.1. Payment Reporting Investigators and their study staff may be asked to provide services performed under this protocol, eg, attendance at Investigator's Meetings. If required under the applicable statutory and regulatory requirements, Gilead will capture and disclose to Federal and State agencies any expenses paid... | [] |
NCT02842086 | 9.3.2 | Access to Information for Monitoring | 9.3.2. Access to Information for Monitoring In accordance with regulations and guidelines, the study monitor must have direct access to the investigator's source documentation in order to verify the accuracy of the data recorded in the eCRF. The monitor is responsible for routine review of the eCRF at regular intervals... | [] |
NCT02842086 | 9.3.3 | Access to Information for Auditing or Inspections | 9.3.3. Access to Information for Auditing or Inspections Representatives of regulatory authorities or of Gilead may conduct inspections or audits of the clinical study. If the investigator is notified of an inspection by a regulatory authority the investigator agrees to notify the Gilead medical monitor immediately. Th... | [] |
NCT02842086 | 9.3.4 | Study Discontinuation | 9.3.4. Study Discontinuation Both the sponsor and the investigator reserve the right to terminate the study at any time. Should this be necessary, both parties will arrange discontinuation procedures and notify the appropriate regulatory authority(ies), IRBs, and IECs. In terminating the study, Gilead and the investiga... | [] |
NCT02842086 | 10 | REFERENCES | 10. REFERENCES - Abdool Karim Q, Abdool Karim SS, Frohlich JA, Grobler AC, Baxter C, Mansoor LE, et al. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science 2010;329 (5996):1168-74. - Anderson P, Liu A, Buchbinder S, Lama J, Guanira J, et al. In... | [] |
NCT02842086 | 11 | APPENDICES | 11. APPENDICES | Appendix 1. | Investigator Signature Page | |-------------|----------------------------------------------------------------------------------| | Appendix 2. | Study Procedures Table | | Appendix 3. | Study Procedures Table (OL Week 96 and beyond) | | Appendix 4. | Management of Clinical and Laboratory ... | [
"Appendix 1. Investigator Signature Page",
"GILEAD SCIENCES, INC. 333 LAKESIDE DRIVE FOSTER CITY, CA 94404",
"STUDY ACKNOWLEDGEMENT",
"GS-US-412-2055, Amendment 7, 19 October 2021",
"Prot-GS-US-412-2055\\amd-7",
"Appendix 2. Study Procedures Table",
"Appendix 3. Study Procedures Table (OL Week 96 and be... |
NCT02842580 | 1 | INTRODUCTION - RATIONALE FOR THE STUDY | 1 INTRODUCTION - RATIONALE FOR THE STUDY | [] |
NCT02842580 | 1.1 | Treatment of metastatic colorectal cancer | 1.1 Treatment of metastatic colorectal cancer The multiplicity of therapeutic weapons and their very different modes of action mean that we can now envisage innovative strategies for the management of metastatic colorectal cancer. Optimization of tumor response (by bi- or tri-chemotherapy + biotherapy) has shown its va... | [] |
NCT02842580 | 1.2 | Rational for the de-escalation strategy | 1.2 Rational for the de-escalation strategy Three phase III trials have compared a "top-down" strategy of induction with bi-chemotherapy (5FU + irinotecan or oxaliplatin), followed at progression by a switch to irinotecan and oxaliplatin, with a "bottom-up" strategy in which 5FU is started alone, followed at progressio... | [] |
NCT02842580 | 2 | RESEARCH OBJECTIVES | 2 RESEARCH OBJECTIVES | [] |
NCT02842580 | 2.1 | Main criterion | 2.1 Main criterion The main objective is to evaluate the rate of patients without strategy failure 16 months after randomization. Strategy failure is defined by (Figure 1): - Progression (defined below according to treatment strategy)\ using RECIST criteria version 1.1 or - Death (all causes) or - Toxicity leading to p... | [
"\\Definition of progression according to treatment strategy (two different strategies):",
"Secondary criteria"
] |
NCT02842580 | 2.2 | Research objectives | 2.2 Research objectives This clinical study comprises 2 types of exploratory research A biological collection is planned as part of the protocol cf page 28 "biological logistics".
Biological: a prospective study of the level of mutated RAS alleles in tissue (tumor) and blood (circulating DNA): - Demonstrate the impact... | [
"Biological: a prospective study of the level of mutated RAS alleles in tissue (tumor) and blood (circulating DNA):",
"Imaging :"
] |
NCT02842580 | 3 | SELECTION CRITERIA | 3 SELECTION CRITERIA | [] |
NCT02842580 | 3.1 | Inclusion criteria | 3.1 Inclusion criteria - Histologically proven metastatic colorectal cancer (on primary tumor and/or metastases) - Non-resectable, non-pre-treated metastases - - Unmutated BRAF - Patient considered suitable for treatment strategies - At least one measurable target lesion > 1cm according to RECIST 1.1 (Appendix 4) - Tum... | [] |
NCT02842580 | 3.2 | Non-inclusion criteria | 3.2 Non-inclusion criteria - - Potentially resectable colorectal cancer, i.e. where the aim of chemotherapy is to render all metastases resectable. - Peripheral sensory neuropathies grade >1 - Symptomatic metastases - Symptomatic tumor in place (occulsion, hemorrhage) - Active peptic ulcer, wound or bone fracture - Inf... | [] |
NCT02842580 | 4 | INITIAL BALANCE SHEET | 4 INITIAL BALANCE SHEET After signing the consents (clinical and biological if applicable), all biological and radiological tests will be carried out at local facilities before initiating the strategy. Patients must be informed of the possibility of preserving their germ cells. The investigator will ask the patient whe... | [
"In the 21 days preceding the patient's randomization:",
"In the 14 days preceding the patient's randomization :",
"Biological check-up including :",
"RAS statutes:",
"Translational research (Appendix 3):",
"Within 72 hours of the first chemotherapy cycle in the strategy:"
] |
NCT02842580 | 5 | HIKING | 5 HIKING | [] |
NCT02842580 | 5.1 | Randomization | 5.1 Randomization Randomization will be carried out by the FFCD's CRGA after the eligibility check-up and signature of the informed consent form, and after receipt of the randomization fax (Form 1 in the observation booklet), by calling 03 80 38 18 41. The CRGA is open Monday to Friday, 9am to 6pm. For further informat... | [] |
NCT02842580 | 5.2 | Stratification | 5.2 Stratification Patients will be randomized (1:1) using the minimization technique (Pocock and Simon (Biometrics, 1975)) according to the following stratification factors: - • Center - WHO performance index 0/1 vs 2 | [] |
NCT02842580 | 6 | TREATMENT | 6 TREATMENT In this academic research, all drugs used in the treatment of modified FOLFOXIRI, FOLFIRI, FOLFOX, LV5FU2, capecitabine and bevacizumab (drugs with AMM used in their indication) will be taken from hospital stock in accordance with article L1121-16-1 of the French Public Health Code. Please note that it is e... | [] |
NCT02842580 | 6.1 | In the 48 hours preceding each cycle | 6.1 In the 48 hours preceding each cycle Full clinical examination: - Weight, body surface area - Blood pressure (PAS and PAD) - General condition WHO Pre-chemotherapy biochemistry : - CBC-platelets - Creatininemia, AST and ALT - Bilirubinemia - Dipstick proteinuria supplemented by 24-hour proteinuria if ≥ 2+. - Toxici... | [] |
NCT02842580 | 6.2 | Sch emas of administration | 6.2 Sch emas of administration | [] |
NCT02842580 | 6.2.1 | Arm A standard strategy | 6.2.1 Arm A standard strategy In the standard arm or escalation strategy, patients will receive 1ère chemotherapy based on LV5FU2 or capecitabine + bevacizumab. After progression, they will receive 2ème chemotherapy with FOLFIRI + bevacizumab. After progression, they will receive 3ème chemotherapy with FOLFOX4 + bevaci... | [
"Simplified LV5FU2 (or capecitabine) + Bevacizumab:",
"FOLFIRI + Bevacizumab:",
"FOLFOX + Bevacizumab:"
] |
NCT02842580 | 6.2.2 | Arm B experimental strategy | 6.2.2 Arm B experimental strategy In the experimental arm or de-escalation strategy, induction treatment (4 cycles of FOLFOXIRI + bevacizumab followed by 4 cycles of FOLFIRI + bevacizumab) is followed by maintenance treatment with capecitabine and bevacizumab until progression. After 1ère progression during maintenance... | [
"Modified FOLFOXIRI + bevacizumab (4 cycles):",
"FOLFIRI + bevacizumab (4 cycles):"
] |
NCT02842580 | 6.3 | Associated treatments | 6.3 Associated treatments
With 5FU No systematic anti-emetic treatment If chest pain: stop 5 FU; check ECG and cardiac enzymes If hand-foot syndrome: moisturizing lotion, oily creams For severe mucositis: mouthwash with bicarbonate 14 0/00, fungizone oral suspension, viscous Xylocaine® if pain and aciclovir if history... | [
"With 5FU",
"With irinotecan",
"With bevacizumab",
"For all treatments"
] |
NCT02842580 | 6.4 | Associated treatments strictly contraindicated | 6.4 Associated treatments strictly contraindicated
With irinotecan - o St. John's wort (Irinotecan): decreased plasma levels of SN-38 - o Yellow fever vaccine: risk of widespread vaccine disease
With capecitabine o Sorivudine or related drugs (such as brivudine): risk of increased potentially fatal toxicity
With oxa... | [
"With irinotecan",
"With capecitabine",
"With oxaliplatin :"
] |
NCT02842580 | 7 | PROCESSING TIME | 7 PROCESSING TIME To correctly evaluate the 2 therapeutic strategies, it is important to respect the alternating treatment sequences of each strategy as described in the administration schedule. The strategy assigned at randomization will be maintained until therapeutic escape, which differs from one strategy to anothe... | [] |
NCT02842580 | 8 | DOSE ADJUSTMENTS TREATMENTS | 8 DOSE ADJUSTMENTS TREATMENTS Toxicities will be assessed before each cycle by questioning, clinical examination and biology, and graded according to NCI-CTC AE version 4.0 criteria (Appendix 8 and leaflet supplied by the FFCD). Dose adjustments are made on the basis of maximum toxicity, and if the patient presents sev... | [
"Oxaliplatin-specific toxicity :"
] |
NCT02842580 | 8.1 | Dose adjustments for 5FU, oxaliplatin and irinotecan | 8.1 Dose adjustments for 5FU, oxaliplatin and irinotecan | Toxicity Grade(NCI-CTC version 4.0) | 5- Fluorouracil | Irinotecanoroxaliplatin(FOLFIRI or FOLFOX)Irinotecanandoxaliplatin(modified FOLFOXIRI) | | |------------------------------------------------------|----------------------------------------------------------... | [] |
NCT02842580 | 8.2 | Capecitabine | 8.2 Capecitabine In the event of toxicity during the capecitabine cycle, treatment should be stopped and the patient should contact a healthcare professional. | Toxicity Grade(NCI-CTC version 4.0) | Dose modification during a treatment cycle | Dosage adjustment for nextcycle/dose (% of initial dosage) | | |------------... | [] |
NCT02842580 | 8.3 | Bevacizumab | 8.3 Bevacizumab Definitive discontinuation of bevacizumab due to toxicity is not a failure of the strategy. Chemotherapy will continue to be administered without bevacizumab.
ARTERIAL HYPERTENSION - take BP after at least 5 minutes' rest - if Systolic BP > 140 mmHg and/or Diastolic BP > 90 mmHg resume after a further ... | [
"ARTERIAL HYPERTENSION",
"THROMBO-EMBOLIC EVENT",
"PROTEINURY",
"INTESTINAL PERFORATION",
"HEMORRAGY",
"REVERSIBLE POSTERIOR ENCEPHALOPATHY SYNDROME (SEPR)",
"OSTEONECROSIS OF THE JAW"
] |
NCT02842580 | 9 | PATIENT MONITORING | 9 PATIENT MONITORING | [] |
NCT02842580 | 9.1 | During treatment | 9.1 During treatment
- Before each chemotherapy cycle: - • Complete clinical examination: weight, body surface area, general condition WHO, blood pressure - Biological workup: CBC, platelets, ionogram (Na, K, Ca), creatinine, creatinine clearance, AST, ALT, total, free and conjugated bilirubin, proteinuria with urine ... | [
"- Before each chemotherapy cycle:",
"- Every 8 weeks:"
] |
NCT02842580 | 9.2 | After discontinuation of protocol treatment | 9.2 After discontinuation of protocol treatment - If the protocol strategy is discontinued due to progression, clinical monitoring is maintained every 3 months for 2 years, then every 6 months for 1 year. The patient's condition and subsequent treatments are recorded in the OC. - - If treatment is stopped before tumor ... | [] |
NCT02842580 | 10 | ORGANIC LOGISTICS | 10 ORGANIC LOGISTICS All patients randomized in the PRODIGE 45 - HIGH-LIGHT study and having signed the specific consent form for this translational research (prospective study of the rate of mutated RAS alleles at tissue level (tumor) and at blood level (circulating DNA) in metastatic colorectal cancer as part of the ... | [
"Determining tumor mutation status",
"Determining mutation status in blood"
] |
NCT02842580 | 11 | MANAGEMENT OF SERIOUS ADVERSE EVENTS (EIG) | 11 MANAGEMENT OF SERIOUS ADVERSE EVENTS (EIG) Safety will be assessed by evaluating patients' general and clinical condition, and by recording events occurring between visits during consultations, and by regular blood tests. Toxicities will be assessed using the NCI-CTC-AE version 4.0 toxicity scale, and collected in t... | [] |
NCT02842580 | 11.1 | Definitions | 11.1 Definitions
Adverse Event (AE) An adverse event is a noxious occurrence in a person undergoing biomedical research, whether or not it is related to the research or to the research product.
Serious adverse event (SAE) A serious adverse event is any event that meets at least one of the following criteria: - Result... | [
"Adverse Event (AE)",
"Serious adverse event (SAE)",
"Undesirable effect",
"Unexpected Serious Adverse Effect",
"Intensity (or severity)",
"Causal relationship",
"Developer's liability"
] |
NCT02842580 | 11.2 | Events not to be considered serious | 11.2 Events not to be considered serious Disease progression should not be considered as a SAE. On the other hand, events potentially linked to the progression of the disease but which may be secondary to treatment should be reported (e.g. thromboembolic events, haemorrhagic phenomena, perforations, etc.). Due to the s... | [] |
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