Informations générales (source: ClinicalTrials.gov)
A Randomized Phase III Study Comparing Maintenance Treatment With Fluoropyrimidine + Bevacizumab Versus Fluoropyrimidine After Induction Chemotherapy for a Metastatic Colorectal Cancer (BEVAMAINT)
Interventional
Phase 3
Centre Hospitalier Universitaire Dijon (Voir sur ClinicalTrials)
janvier 2020
décembre 2025
29 juin 2024
The aim of BEVAMAINT is to improve benefic effect of maintenance therapy after a first
line of induction chemotherapy for patients with colorectal cancer
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Val�rie BOIGE | 16/04/2024 08:58:31 | Contacter | ||
| HOPITAL NOVO | AL SHEIKH | 04/07/2024 11:05:05 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Chu Dijon Bourgogne - Dijon - France | Sylvain MANFREDI | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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