# PRODIGE 7

Source: https://onco.cc/trials/prodige-7/  
OnCo record `prodige-7` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Washing the abdomen with heated oxaliplatin after complete tumour removal added nothing to survival and caused more late complications. The surgery, not the wash, is what works.

## Summary

PRODIGE 7 randomised 265 patients at 17 French centres who had achieved complete macroscopic resection of colorectal peritoneal metastases to oxaliplatin-based HIPEC (360 mg/m2 closed or 460 mg/m2 open abdomen, with intravenous fluorouracil and folinic acid 20 minutes before) or to no HIPEC. After a median 63.8 months, median overall survival was 41.7 against 41.2 months (hazard ratio 1.00, 95.37% CI 0.63 to 1.58, p=0.99). Grade 3 or worse adverse events at 60 days were more common with HIPEC (26 against 15 percent, p=0.035). Both arms did far better than historical series treated with chemotherapy alone, which is the trial's positive message: complete cytoreductive surgery in selected patients gives a median survival above three years. HIPEC with oxaliplatin does not add to it, and COLOPEC and PROPHYLOCHIP separately showed it does not work as prophylaxis either.

## Fields

- Kind: Trial
- Status: negative
- Last checked: 2026-09-24
- Registry id: NCT00769405
- Phase: 3
- Setting: Colorectal peritoneal metastases with a Peritoneal Cancer Index of 25 or less, after complete macroscopic cytoreduction: oxaliplatin HIPEC added or not, with systemic chemotherapy in both arms
- Sponsor: UNICANCER
- Enrolled: 265
- Result: Median overall survival 41.7 against 41.2 months (hazard ratio 1.00); more late grade 3 or worse complications with HIPEC.
- Outcomes: Overall survival: Cytoreductive surgery plus oxaliplatin HIPEC 41.7 months vs Cytoreductive surgery alone 41.2 months, HR 1
- Replication: COLOPEC (adjuvant HIPEC) and PROPHYLOCHIP (second-look surgery plus HIPEC) were also negative, so three randomised trials agree.

## Sources

- ClinicalTrials.gov NCT00769405: https://clinicaltrials.gov/study/NCT00769405
- PRODIGE 7: cytoreductive surgery plus HIPEC versus cytoreductive surgery alone for colorectal peritoneal metastases (Lancet Oncology 2021): https://doi.org/10.1016/S1470-2045(20)30599-4

## Connected records

- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/)
- technologies: [HIPEC / PIPAC (intraperitoneal chemotherapy)](https://onco.cc/technologies/hipec/), [HIPEC perfusion pumps and PIPAC nebulisers](https://onco.cc/technologies/hipec-pipac-devices/)
- drugs: [Fluorouracil (5-FU)](https://onco.cc/drugs/fluorouracil/), [Leucovorin (folinic acid)](https://onco.cc/drugs/leucovorin/), [Oxaliplatin](https://onco.cc/drugs/oxaliplatin/)
- companies: [UNICANCER](https://onco.cc/companies/unicancer/)
- terms: [Colorectal cancer: the failed and stopped programmes, and why](https://onco.cc/terms/colorectal-failed-programmes/), [Debulking (cytoreductive surgery)](https://onco.cc/terms/debulking/)
- trials: [COLOPEC](https://onco.cc/trials/colopec/), [Netherlands Cancer Institute HIPEC trial](https://onco.cc/trials/netherlands-hipec/), [PROPHYLOCHIP-PRODIGE 15](https://onco.cc/trials/prophylochip/)

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