Comparing two maintenance treatments for metastatic colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of maintenance therapy using a combination of fluoropyrimidine and bevacizumab compared to fluoropyrimidine alone after initial induction chemotherapy in patients with metastatic colorectal cancer. Participants will be those who have shown disease control following their first-line treatment. The study will assess the outcomes of these two treatment approaches to determine which provides better long-term benefits for patients.

Why it matters

Who can join: the full rules

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

Where it's running

• Chu Dijon Bourgogne
  Dijon, France Recruiting

Study contacts

• Study coordinator: Thomas Aparicio
• Email: thomas.aparicio@aphp.fr
• Phone: (0)1 42 49 95 97

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Combination therapy for metastatic colorectal cancer with BRAF-V600E mutation

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.