Phase 3
N=204
Adjuvant HIPEC in High Risk Colon Cancer
Colorectal Neoplasms · Peritoneal Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT02231086 ↗Enrolled (actual)
204
Serious AEs
69.8%
Results posted
Sep 2021
Primary outcome: Primary: Peritoneal Recurrence Free Survival at 18 Months — 79; 80 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Adjuvant HIPEC (open/laparoscopic) (Procedure); Standard adjuvant systemic chemotherapy (Drug); Diagnostic laparoscopy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Primary completion
- Sep 2018
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 |
— | — |
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.
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). 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.