Clinical trial · Interventional
Combined Anticancer Treatment of Advanced Colon Cancer
Multimodality Treatment Including Pre- and Postoperative Systemic Chemotherapy Plus Cetuximab, Cytoreductive Surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Peritoneal Carcinomatosis Arising From Wild Type K-ras Colon Cancer: A Prospective Multicenter Phase II Study.
NCT01540344CI-TRIAL-00034709COMBATACterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow recruitment.
Summary
Brief summary (as posted)
The COMBATAC study evaluates the the effect as assessed by progression-free survival (PFS) of perioperative systemic chemotherapy including cetuximab and cytoreductive surgery (CRS) and bidirectional hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with peritoneal carcinomatosis arising 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 Metastatic | — | UNRESOLVED | — |
| Peritoneal Carcinomatosis | Peritoneal Carcinomatosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CRS | Procedure | — | UNRESOLVED |
| HIPEC | Drug | Hyperthermic Intraperitoneal Chemotherapy | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Arm
- description
- 1. FOLFOX/FOLFIRI + cetuximab (6 cycles) 2. CRS and HIPEC 3. FOLFOX/FOLFIRI + cetuximab (6 cycles)
- interventionNames
- Procedure: CRS
- Drug: HIPEC
Primary outcomes (1)
- measure
- Progression-free survival (PFS)
- timeFrame
- 24 months
Secondary outcomes (4)
- measure
- Overall survival (OS)
- timeFrame
- 5 years
- measure
- Feasibility of the combined treatment concept
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 71 Years
Show eligibility criteria text
Inclusion Criteria: * Synchronous or metachronous peritoneal carcinomatosis arising from histologically proven colorectal or appendiceal adenocarcinoma * Complete macroscopic cytoreduction (CCR-0/1) * Free treatment interval of at least 6 month after the last chemotherapy * Age over 18 and below 71 years * Good general health status (Karnofsky \> 70%, ECOG 0-2) * Absence of hematogenous metastasis (lung, bone, brain, \> 3 peripheric resectable liver metastases) * Absence of contraindication for systemic chemotherapy and/or extended surgery * Life expectancy greater than 6 months * Written informed consent * Creatinine clearance \> 50 ml/min, serum creatinine ≤ 1.5 x ULN * Serum bilirubin ≤ 1.5 x ULN (upper limit of normal), ASAT and ALAT ≤ 2.5 x ULN * Platelet count \> 100,000 /ml, haemoglobin \> 9 g/dl, neutrophile granulocytes ≥ 1,500 /ml, International Normalized Ration (INR) ≤ 2 * Absence of peripheral neuropathy \> grade 1 (CTCAE v4.0) * No pregnancy or breast feeding. Adequate contraception in fertile patients. Exclusion Criteria: * Incomplete cytoreduction * Hematogenous metastasis including irresectable liver metastasis * Prior chemotherapy or therapy with EGFR receptor antibody for metastatic disease * K-ras mutation * Known allergy to murine or chimeric monoclonal antibodies * Histology of signet ring carcinoma * Other malignancy than disease under study / second cancer * Impaired liver, renal or hematologic function as mentioned above (inclusion criteria) * Heart failure NYHA ≥ 2 or significant Coronary Artery Disease * Alcohol and/or drug abuse * Patients unable or unwilling to comply with the study protocol, treatment or follow-up * Patients included in other clinical trials interfering with the present study
References
Publications (2)
- BACKGROUNDGlockzin G, Rochon J, Arnold D, Lang SA, Klebl F, Zeman F, Koller M, Schlitt HJ, Piso P. A prospective multicenter phase II study evaluating multimodality treatment of patients with peritoneal carcinomatosis arising from appendiceal and colorectal cancer: the COMBATAC trial. BMC Cancer. 2013 Feb 7;13:67. doi: 10.1186/1471-2407-13-67. PMID 23391248
- RESULTGlockzin G, Zeman F, Croner RS, Konigsrainer A, Pelz J, Strohlein MA, Rau B, Arnold D, Koller M, Schlitt HJ, Piso P. Perioperative Systemic Chemotherapy, Cytoreductive Surgery, and Hyperthermic Intraperitoneal Chemotherapy in Patients With Colorectal Peritoneal Metastasis: Results of the Prospective Multicenter Phase 2 COMBATAC Trial. Clin Colorectal Cancer. 2018 Dec;17(4):285-296. doi: 10.1016/j.clcc.2018.07.011. Epub 2018 Jul 31. PMID 30131226