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A Randomized Phase III Study Comparing Maintenance Treatment With Fluoropyrimidine + Bevacizumab Versus Fluoropyrimidine After Induction Chemotherapy for a Metastatic Colorectal Cancer (BEVAMAINT)

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ClinicalTrials.gov Identifier: NCT04188145
Recruitment Status : Recruiting
First Posted : December 5, 2019
Last Update Posted : October 28, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Tracking Information
First Submitted Date  ICMJE December 3, 2019
First Posted Date  ICMJE December 5, 2019
Last Update Posted Date October 28, 2021
Actual Study Start Date  ICMJE January 27, 2020
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2019)
The Time-to-Treatment Failure (TTF) [ Time Frame: 8 months ]
Will be calculated from date of randomization (after the end of induction chemotherapy) to first radiological progression (according to RECIST 1.1) or death or start of a new chemotherapy (induction regimen or second line) or end of maintenance treatment without further chemotherapy, even if there is no radiological progression. Patients alive with no radiological progression and under maintenance treatment will be censored at the date of last news.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2019)
  • Progression-free survival (PFS1) [ Time Frame: 16 months ]
    Defined as the time between randomization and the first radiological progression (according to RECIST 1.1) or death (whatever occurs first). Patients alive and without progression will be censored at the date of last news.
  • Progression-free survival (PFS2) [ Time Frame: 16 months ]
    Defined as the time between the end of maintenance treatment (whatever the reason is) and the radiological progression after this end of maintenance treatment or death whatever the cause. Patients alive and without progression will be censored at the date of last news.
  • Overall Survival (OS) [ Time Frame: 3 years ]
    Defined as the time between randomization and death (any cause). Patients alive will be censored at the date of last news.
  • Safety [ Time Frame: 3 years ]
    Toxicities will be graded according to the NCI-CTC v 4.0 criteria before each cycle.
  • Quality of Life (QoL) [ Time Frame: 3 years ]
    Assessed at each evaluation with a questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Phase III Study Comparing Maintenance Treatment With Fluoropyrimidine + Bevacizumab Versus Fluoropyrimidine After Induction Chemotherapy for a Metastatic Colorectal Cancer
Official Title  ICMJE A Randomized Phase III Study Comparing Maintenance Treatment With Fluoropyrimidine + Bevacizumab Versus Fluoropyrimidine After Induction Chemotherapy for a Metastatic Colorectal Cancer
Brief Summary The aim of BEVAMAINT is to improve benefic effect of maintenance therapy after a first line of induction chemotherapy for patients with colorectal cancer
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Colorectal Cancer
Intervention  ICMJE
  • Drug: Fluoropyrimidine

    Option 1: Capecitabine 1250 mg/m2 twice daily (i.e. 2500 mg/m²/d) (D1 to D14, D1 = D22) For frail patients according to investigator evaluation capecitabine dose may be reduced to 1000 mg/m2 twice daily (2000 mg/m²/d).

    Or Option 2: Capecitabine 625 mg/m2 twice daily (i.e. 1250 mg/m²/d) (D1 to D21, D1 = D22) Or Option 3: LV5FU2 simplified (folinic acid 200 mg/m² (or Elvorin 400 mg/m²) IV during 2h followed by 5-FU bolus IV of 400 mg/m² during 10 min and IV continuous 5-FU at 2400 mg/m² during 46h). (D1=D15).

  • Drug: Bevacizumab

    Option 1 and Option 2 : D1 bevacizumab 7.5 mg/kg IV (D1=D21). See smPCs for infusion time of bevacizumab.

    Or Option 3: D1 bevacizumab 5 mg/kg IV (D1=D15). See smPCs for infusion time of bevacizumab

Study Arms  ICMJE
  • Active Comparator: Fluoropyrimidine
    Intervention: Drug: Fluoropyrimidine
  • Active Comparator: Fluoropyrimidine + Bevacizumab
    Interventions:
    • Drug: Fluoropyrimidine
    • Drug: Bevacizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 3, 2019)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed metastatic colorectal adenocarcinoma before induction treatment
  • Measurable or non-measurable lesion before the induction treatment according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
  • Metastatic, unresectable disease according local practice after induction treatment
  • ECOG performance status ≤ 2
  • Disease control (complete response, partial response or stable disease) after 4-6 months of frontline induction chemotherapy with doublet (fluoropyrimidine + irinotecan or oxaliplatin) or triplet (fluoropyrimidine + irinotecan + oxaliplatin) +/- (cetuximab, panitumumab, bevacizumab) or IAH chemotherapy
  • Life expectancy > 3 months
  • Age ≥ 18 years
  • Patient is at least 4 weeks from any major surgery
  • Total bilirubin < 25 µmol/L, ASAT < 3 x ULN, ALAT < 3 x ULN (ASAT , ALAT < 5 x ULN in case of hepatic metastasis) , PT >60% , PAL<2.5 x ULN ( < 5 x ULN in case of hepatic metastasis) - Neutrophils > 1500/mm3, platelets > 100 000/mm3, haemoglobin ≥ 9 g/dL
  • Creatinin clearance > 30 ml/min (MDRD) - if creatinin clearance comprised between 30 and 50 ml/min, see smPCs for dose adjustments
  • Proteinuria ≤ 2+ (dipstick urinalysis) (if more than 2+, so proteinuria at or ≤1g/24hour must be ≤1g)
  • Patient is able to understand, sign, and date the written informed consent
  • Evidence of post-menopausal status or negative urinary or serum pregnancy test for premenopausal female patients
  • Male and female patients of childbearing potential agree to use a highly effective contraceptive measure
  • Patient affiliated to a social security system

Exclusion Criteria:

  • Myocardial infarction, severe coronaropathy or severe cardiac dysfunction less than 6 months prior randomization
  • Follow-up impossible
  • Patients with all metastases resected (R0/R1) after induction chemotherapy
  • Patient with a hand-foot syndrome > 1 before maintenance treatment
  • Known brain or leptomeningeal metastases
  • Other concomitant or previous malignancy, except: adequately treated in situ carcinoma in complete remission for > 5 years
  • Uncontrolled hypertension (defined as systolic blood pressure >140 mmHg and/or diastolic blood pressure >90 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy
  • Pregnancy or breast feeding
  • Treatment with sorivudine or analogs (brivudine)
  • Treatment with phenytoin or analogs
  • Partial or complete DPD deficiency (Uracilemia ≥ 16 ng/ml)
  • Peptic ulcer not healed after treatment
  • Any contraindication to bevacizumab or fluoropyrimidine treatments according to the updated SmPC
  • Intestinal perforation or intestinal fistula
  • Previous or active gastrointestinal bleeding
  • Thromboembolic event and/or history of thromboembolic event
  • Severe hepatic insufficiency
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Thomas Aparicio (0)1 42 49 95 97 ext +33 thomas.aparicio@aphp.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04188145
Other Study ID Numbers  ICMJE PRODIGE 71
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Centre Hospitalier Universitaire Dijon
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Centre Hospitalier Universitaire Dijon
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Centre Hospitalier Universitaire Dijon
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP