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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04188145
Recruitment Status : Not yet recruiting
First Posted : December 5, 2019
Last Update Posted : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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

Condition or disease Intervention/treatment Phase
Patients With Metastatic Colorectal Cancer Drug: Fluoropyrimidine Drug: Bevacizumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase III Study Comparing Maintenance Treatment With Fluoropyrimidine + Bevacizumab Versus Fluoropyrimidine After Induction Chemotherapy for a Metastatic Colorectal Cancer
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Active Comparator: Fluoropyrimidine 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).


Active Comparator: Fluoropyrimidine + Bevacizumab 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





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Safety [ Time Frame: 3 years ]
    Toxicities will be graded according to the NCI-CTC v 4.0 criteria before each cycle.

  5. Quality of Life (QoL) [ Time Frame: 3 years ]
    Assessed at each evaluation with a questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04188145


Contacts
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Contact: Thomas Aparicio (0)1 42 49 95 97 ext +33 thomas.aparicio@aphp.fr

Locations
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France
Chu Dijon Bourgogne
Dijon, France
Contact: Sylvain MANFREDI    (0)3 80 29 37 50 ext +33    sylvain.manfredi@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT04188145    
Other Study ID Numbers: PRODIGE 71
First Posted: December 5, 2019    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors