Comparing two maintenance treatments for metastatic colorectal cancer
A Randomized Phase III Study Comparing Maintenance Treatment With Fluoropyrimidine + Bevacizumab Versus Fluoropyrimidine After Induction Chemotherapy for a Metastatic Colorectal Cancer
This study is testing whether a combination of two drugs can help people with metastatic colorectal cancer stay healthier for longer compared to using just one of the drugs after their initial treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Dijon Academic / other |
| Drugs / interventions | cetuximab, panitumumab, bevacizumab, chemotherapy |
| Locations | 1 site (Dijon) |
| Trial ID | NCT04188145 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed metastatic colorectal adenocarcinoma who have achieved disease control after initial chemotherapy.
Not a fit: Patients with resectable disease or those who have not responded to initial chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved maintenance treatment options for patients with metastatic colorectal cancer, potentially enhancing their quality of life and survival rates.
How similar studies have performed: Other studies have shown promising results with similar maintenance treatment approaches in colorectal cancer, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dijon
- Chu Dijon Bourgogne — Dijon, France (Recruiting)
Study contacts
- Study coordinator: Thomas Aparicio
- Email: thomas.aparicio@aphp.fr
- Phone: (0)1 42 49 95 97
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.