Clinical trial · Interventional
Adjuvant HIPEC in High Risk Colon Cancer
Adjuvant Hyperthermic Intraperitoneal Chemotherapy in Patients With Colon Cancer at High Risk of Peritoneal Carcinomatosis
NCT02231086CI-TRIAL-00053895COLOPECcompletedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to determine the oncological effectiveness of adjuvant HIPEC, using intraperitoneal oxaliplatin with concomitant i.v. 5-FU/LV, following a curative resection of a T4 or intra-abdominally perforated Colon cancer in preventing the development of peritoneal carcinomatosis in addition to the standard adjuvant systemic treatment. Hypothesis: The hypothesis is that adjuvant HIPEC preceding routine adjuvant systemic therapy using i.p. oxaliplatin with concomitant i.v. 5-FU/LV following a curative resection of a T4 or intra-abdominally perforated colon cancer reduces the development of peritoneal carcinomatosis in comparison to standard adjuvant systemic treatment alone.
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 Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Peritoneal Neoplasms | Peritoneal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant HIPEC (open/laparoscopic) | Procedure | — | UNRESOLVED |
| Diagnostic laparoscopy | Procedure | — | UNRESOLVED |
| Standard adjuvant systemic chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard adjuvant systemic chemotherapy
- description
- Standard adjuvant systemic chemotherapy according to the Dutch colon cancer guideline, using a capecitabine and oxaliplatin (CAPOX) or 5-FU and oxaliplatin (FOLFOX) schedule. Presence or absence of peritoneal recurrence will be evaluated by laparoscopy in case of negative routine examination (CEA and CT thorax/abdomen) at 18 months postoperatively.
- interventionNames
- Drug: Standard adjuvant systemic chemotherapy
- Procedure: Diagnostic laparoscopy
- type
- EXPERIMENTAL
- label
- Adjuvant HIPEC (open/laparoscopic)
- description
- Adjuvant HIPEC will be performed simultaneously with primary tumor resection, or as a staged procedure (\<10 days or 5-8 weeks postoperatively). The chemotherapy during oxaliplatin-HIPEC consists of an intravenous phase with leucovorin 20 mg/m2 (maximum 40 mg) and 5-fluorouracil 400 mg/m2 (maximum 800 mg) and an intraperitoneal phase with oxaliplatin 460 mg/m2 (maximal 920 mg). Standard adjuvant systemic chemotherapy according to the national guideline will be given within 3 weeks from HIPEC. Presence or absence of peritoneal recurrence will be evaluated by laparoscopy in case of negative routine examination (CEA and CT thorax/abdomen) at 18 months postoperatively.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * age between 18 and 75 years * Intention to start routine adjuvant systemic therapy * adequate clinical condition to undergo simultaneous HIPEC or re- laparoscopy or re-laparotomy with HIPEC within either 10 days or between week 5-8 from --primary resection * written informed consent * white blood cell count of at least 3000/mm3, platelet count of at least 100.000/mm3 * no bleeding diathesis or coagulopathy * normal creatinine or creatinine clearance of at least 50 ml/min Exclusion Criteria: * postoperative complications that interfere with adjuvant HIPEC within 8 weeks (i.e. persisting intra-abdominal abscess, significant fascial dehiscence, enteric fistula) * no intention to start routine adjuvant systemic therapy * liver and/or lung metastases * pregnant or lactating women * unstable or uncompensated respiratory or cardiac disease * serious active infections * other concurrent chemotherapy * hypersensitivity to fluorouracil, folinic acid or another substance of leucovorin or oxaliplatin * stomatitis, ulceration in the mouth or gastrointestinal tract. * severe diarrhea * severe hepatic and / or renal dysfunction. * plasma bilirubin concentrations greater than 85 μmol/l. * pernicious anemia or other anaemias due to vitamin B12 deficiency. * peripheral sensory neuropathy with functional impairment.
References
Publications (5)
- DERIVEDZwanenburg ES, Wisselink DD, Klaver CEL, Bilt JDWV, den Berg JGV, Kodach LL, Nagtegaal ID, Tanis PJ, Snaebjornsson P; COLOPEC collaborators. Underdiagnosis of positive resection margins and synchronous peritoneal metastases in locally advanced colon cancer: histopathological reassessment of primary resection in the COLOPEC trial. Virchows Arch. 2025 Oct;487(4):787-797. doi: 10.1007/s00428-025-04065-x. Epub 2025 May 16. PMID 40374989
- DERIVEDZwanenburg ES, El Klaver C, Wisselink DD, Punt CJA, Snaebjornsson P, Crezee J, Aalbers AGJ, Brandt-Kerkhof ARM, Bremers AJA, Burger PJWA, Fabry HFJ, Ferenschild FTJ, Festen S, van Grevenstein WMU, Hemmer PHJ, de Hingh IHJT, Kok NFM, Kusters M, Musters GD, Schoonderwoerd L, Tuynman JB, van de Ven AWH, van Westreenen HL, Wiezer MJ, Zimmerman DDE, van Zweeden A, Dijkgraaf MGW, Tanis PJ; COLOPEC Collaborators Group; COLOOPEC Collaborators Group. Adjuvant Hyperthermic Intraperitoneal Chemotherapy in Patients With Locally Advanced Colon Cancer (COLOPEC): 5-Year Results of a Randomized Multicenter Trial. J Clin Oncol. 2024 Jan 10;42(2):140-145. doi: 10.1200/JCO.22.02644. Epub 2023 Nov 3. PMID 37922442
- DERIVEDZwanenburg ES, Wisselink DD, Klaver CEL, van der Bilt JDW, Tanis PJ, Snaebjornsson P; COLOPEC trial collaborators. The measured distance between tumor cells and the peritoneal surface predicts the risk of peritoneal metastases and offers an objective means to differentiate between pT3 and pT4a colon cancer. Mod Pathol. 2022 Dec;35(12):1991-2001. doi: 10.1038/s41379-022-01154-z. Epub 2022 Sep 19. PMID 36123540
- DERIVEDKlaver CEL, Wisselink DD, Punt CJA, Snaebjornsson P, Crezee J, Aalbers AGJ, Brandt A, Bremers AJA, Burger JWA, Fabry HFJ, Ferenschild F, Festen S, van Grevenstein WMU, Hemmer PHJ, de Hingh IHJT, Kok NFM, Musters GD, Schoonderwoerd L, Tuynman JB, van de Ven AWH, van Westreenen HL, Wiezer MJ, Zimmerman DDE, van Zweeden AA, Dijkgraaf MGW, Tanis PJ; COLOPEC collaborators group. Adjuvant hyperthermic intraperitoneal chemotherapy in patients with locally advanced colon cancer (COLOPEC): a multicentre, open-label, randomised trial. Lancet Gastroenterol Hepatol. 2019 Oct;4(10):761-770. doi: 10.1016/S2468-1253(19)30239-0. Epub 2019 Jul 29. PMID 31371228