NCT04188145Active, not recruitingPhase 3
A Randomized Phase III Study Comparing Maintenance Treatment With Fluoropyrimidine + Bevacizumab Versus Fluoropyrimidine After Induction Chemotherapy for a Metastatic Colorectal Cancer
Centre Hospitalier Universitaire Dijon2 sites in 1 country400 target enrollmentStarted: January 27, 2020Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Enrollment
- 400
- Locations
- 2
- Primary Endpoint
- The Time-to-Treatment Failure (TTF)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Fluoropyrimidine + Bevacizumab
Active Comparator
Intervention: Bevacizumab (Drug)
Fluoropyrimidine
Active Comparator
Intervention: Fluoropyrimidine (Drug)
Fluoropyrimidine + Bevacizumab
Active Comparator
Intervention: Fluoropyrimidine (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Overall Survival (OS)(3 years)
- Quality of Life (QoL)(3 years)
- Progression-free survival (PFS1)(16 months)
- Progression-free survival (PFS2)(16 months)
- Safety(3 years)
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Unknown
Phase 3
Trial Evaluating Maintenance Chemotherapy for Metastatic Nasopharyngeal CarcinomaNasopharyngeal CarcinomaNCT02944708Shanghai Proton and Heavy Ion Center384
Completed
Phase 3
A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI)Crohn's DiseaseColitisInflammatory Bowel DiseaseIBDNCT01369355Janssen Research & Development, LLC1,282
Unknown
Phase 3
The Maintenance Treatment of Apatinib/Capecitabine Versus Observation in Advanced Gastric CancerStomach NeoplasmsGastrointestinal NeoplasmsStomach DiseasesDigestive System NeoplasmsCapecitabineApatinibNeoplasmsMolecular Mechanisms of Pharmacological ActionNCT03889626Fudan University242
Completed
Phase 3
Randomised Study of Oral Azacitidine vs Placebo Maintenance in AML or MDS Patients After Allo-SCTAcute Myeloid LeukemiaMyelodysplasiaNCT04173533University of Birmingham326
Unknown
Phase 3
Pemetrexed Maintenance in Patients With Urothelial Carcinoma Who Completed First Line Platinum-based ChemotherapyUreter CancerTransitional Cell CarcinomaBladder CancerNCT03193788Asan Medical Center74