Phase 3
Completed N=204
Adjuvant HIPEC in High Risk Colon Cancer
Source: ClinicalTrials.gov NCT02231086 ↗Enrolled (actual)
204
Serious AEs
69.8%
Results posted
Sep 2021
Primary outcomePrimary: Peritoneal Recurrence Free Survival at 18 Months — 79; 80 participants
◆ Published Evidence
Highly cited
322citations · ~46 / year
Adjuvant hyperthermic intraperitoneal chemotherapy in patients with locally advanced colon cancer (COLOPEC): a multicentre, open-label, randomised trial.
Summary
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.
Linked Publications (5)
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Adjuvant hyperthermic intraperitoneal chemotherapy in patients with locally advanced colon cancer (COLOPEC): a multicentre, open-label, randomised trial.
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Adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with colon cancer at high risk of peritoneal carcinomatosis; the COLOPEC randomized multicentre trial.
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Adjuvant Hyperthermic Intraperitoneal Chemotherapy in Patients With Locally Advanced Colon Cancer (COLOPEC): 5-Year Results of a Randomized Multicenter Trial.
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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.
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Underdiagnosis of positive resection margins and synchronous peritoneal metastases in locally advanced colon cancer: histopathological reassessment of primary resection in the COLOPEC trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peritoneal Recurrence Free Survival at 18 Months |
79; 80 | — |
| SECONDARY Treatment Related Toxicity of Adjuvant HIPEC |
0; 0 | — |
| SECONDARY Hospital Stay for Simultaneous and Staged HIPEC, Either Open or Laparoscopic |
— | — |
| SECONDARY False-negative Rate of CT-scan for Peritoneal Metastases |
— | — |
| SECONDARY Patterns of Dissemination (Peritoneal Plus or Minus Distant Metastases) |
— | — |
| SECONDARY Disease-free Survival |
— | — |
| SECONDARY Overall Survival |
— | — |
| SECONDARY Quality of Life Questionnaire Survey 5- Year Follow-up |
— | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02231086) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.