Clinical trial · Interventional
Chemotherapy and Cetuximab in Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer
Clinical Phase II Study Evaluating Systemic Chemotherapy in Combination With Cetuximab as Adjuvant Treatment in Patients With Completely Surgically Resected Peritoneal Carcinomatosis of Colorectal Origin
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): In 2008, new data highlighted that Cetuximab had no efficacy in case of KRAS mutation. As such, eligibility criteria were revised and limited to KRAS wild-type. Inclusions were thus slown down considerably, and the trial was stopped.
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving more than one drug (combination chemotherapy) together with cetuximab may kill more tumor cells. PURPOSE: This phase II trial is studying how well chemotherapy given together with cetuximab works in treating patients undergoing surgery to remove peritoneal carcinomatosis from colorectal cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Primary Peritoneal Cavity Cancer | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| cetuximab | Biological | Cetuximab | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemotherapy + Cetuximab
- description
- Surgery + Chemotherapy + Cetuximab
- interventionNames
- Biological: cetuximab
- Drug: fluorouracil
- Drug: leucovorin calcium
- Drug: oxaliplatin
- Procedure: adjuvant therapy
- Procedure: therapeutic conventional surgery
Primary outcomes (1)
- measure
- Median Progression-free Survival (PFS) Time
- timeFrame
- Since surgery, up to 5 years
- description
- Progression-free survival time is defined as the time from the date of surgery to the date of progression (as per RECIST v1.1) or death of any cause, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed colorectal adenocarcinoma meeting the following criteria: * Exclusively peritoneal carcinomatosis (no other metastases) * Resectable disease * Primary tumor may be same in the same location as another synchronous carcinomatosis * Patients with metastatic disease who have been in complete remission for more than 1 year are eligible regardless of prior chemotherapy PATIENT CHARACTERISTICS: * WHO performance status 0-2 * Life expectancy ≥ 12 weeks * ANC ≥ 1.5 x 10\^9/L * Platelet count ≥ 100 x 10\^9/L * Hemoglobin ≥ 10 g/dL * Bilirubin ≤ 1.25 times upper limit of normal (ULN) * AST and ALT ≤ 3 times ULN * Creatinine ≤ 1.25 times ULN * Creatinine clearance ≥ 30 mL/min * Not pregnant or nursing * Fertile patients must use effective contraception * No allergy, hypersensitivity, or other contraindication to leucovorin calcium, oxaliplatin, or fluorouracil * No other noncancerous disease that would preclude study therapy * Good nutritional status * No sensitive peripheral neuropathy with functional impairment * No hypoplasia or bone marrow failure * No clinically significant cardiovascular disease within the past year (e.g., unstable angina or myocardial infarction) * No other cancer within the past 5 years unless in complete remission with the exception of cervical carcinoma in situ or basal cell cancer * No patients deprived of liberty or under supervision * No psychological, social, familial, or geographical reasons prohibiting follow-up PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 1 year since prior adjuvant chemotherapy, including prior therapy with oxaliplatin and/or cetuximab * No prophylactic phenytoin (Dihydan®, Dilantin®) * No prior yellow fever vaccine * More than 1 month since participation in another study
References
Publications (1)
- RESULTEvrard S, Desolneux G, Bellera C, Esnaud T, Becouarn Y, Collet D, Chafai N, Marchal F, Cany L, Lermite E, Rivoire M, Mathoulin-Pelissier S. Systemic chemotherapy plus cetuximab after complete surgery in the treatment of isolated colorectal peritoneal carcinoma: COCHISE phase II clinical trial. BMC Res Notes. 2019 Jul 22;12(1):450. doi: 10.1186/s13104-019-4476-9. PMID 31331370