# Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy versus cytoreductive surgery alone for colorectal peritoneal metastases (PRODIGE 7)

Source: https://onco.cc/key-papers/paper-quenet-prodige-7-hipec-peritoneal-colorectal-lancet-oncol-2021/  
OnCo record `paper-quenet-prodige-7-hipec-peritoneal-colorectal-lancet-oncol-2021` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The trial that took the heated chemotherapy away and found the survival was the same: 41.7 against 41.2 months. The benefit had always been in the surgery.

## Summary

Quénet, Elias, Roca and colleagues ran a randomised open-label phase 3 trial at 17 cancer centres in France in patients aged 18 to 70 with histologically proven colorectal cancer and peritoneal metastases, WHO performance status 0 or 1, a Peritoneal Cancer Index of 25 or less, and eligibility for six months of systemic chemotherapy. Patients in whom complete macroscopic resection, or resection with less than 1 mm of residual tumour, was achieved were randomised 1:1 to cytoreductive surgery with or without oxaliplatin-based hyperthermic intraperitoneal chemotherapy. All patients received systemic chemotherapy with or without targeted therapy before or after surgery, or both. The primary endpoint was overall survival in the intention-to-treat population.

Between February 2008 and January 2014, 265 patients were randomised: 133 to surgery plus hyperthermic intraperitoneal chemotherapy and 132 to surgery alone.

## Fields

- Kind: Key paper
- Last checked: 2026-09-24
- Tags: colorectal-evidence
- Journal: The Lancet Oncology
- Year: 2021
- DOI: 10.1016/S1470-2045(20)30599-4
- Authors: Quénet F, Elias D, Roca L, et al.
- Findings: After a median 63.8 months, median overall survival 41.7 months (95 percent CI 36.2 to 53.8) with hyperthermic intraperitoneal chemotherapy against 41.2 months (35.1 to 49.7) without: hazard ratio 1.00 (95.37 percent CI 0.63 to 1.58), stratified log-rank p=0.99.; Two treatment-related deaths at 30 days in each group.; Grade 3 or worse adverse events at 30 days were similar (56 of 133, 42 percent, against 42 of 132, 32 percent; p=0.083) but more common at 60 days with hyperthermic intraperitoneal chemotherapy (34 of 131, 26 percent, against 20 of 130, 15 percent; p=0.035).
- What it means: Complete cytoreductive surgery with modern systemic chemotherapy gives a median survival over 40 months in selected patients with peritoneal metastases, and the heated intraperitoneal oxaliplatin adds only late complications.
- Caveats: The trial tests oxaliplatin-based hyperthermic chemotherapy specifically; mitomycin-based regimens and pressurised aerosol delivery are not addressed.; Highly selected patients: Peritoneal Cancer Index 25 or less, under 70, fit for six months of chemotherapy, and randomised only after complete cytoreduction was achieved.; A 41-month median survival in both arms is far better than historic series and reflects that selection, not a general result for peritoneal disease.

## Sources

- Lancet Oncol 2021: https://doi.org/10.1016/S1470-2045(20)30599-4
- PubMed: https://pubmed.ncbi.nlm.nih.gov/33476595/

## Connected records

- key papers: [Randomized trial of cytoreduction and hyperthermic intraperitoneal chemotherapy versus systemic chemotherapy and palliative surgery in patients with peritoneal carcinomatosis of colorectal cancer](https://onco.cc/key-papers/paper-verwaal-cytoreduction-hipec-peritoneal-colorectal-jco-2003/)
- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/)
- fronts: [Chemotherapy](https://onco.cc/fronts/chemotherapy/), [Surgery & Interventional](https://onco.cc/fronts/surgery/)
- technologies: [HIPEC / PIPAC (intraperitoneal chemotherapy)](https://onco.cc/technologies/hipec/)
- 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/)
- bottlenecks: [Failures are hidden](https://onco.cc/bottlenecks/b-negative-results/), [Surgery and radiotherapy cure most, get least](https://onco.cc/bottlenecks/b-surgery-radiation-innovation/)
- journals: [The Lancet Oncology](https://onco.cc/journals/lancet-oncology/)
- roadmaps: [Colorectal cancer roadmap: from the adenoma-carcinoma sequence and the first screening trials to total mesorectal excision, oxaliplatin, RAS testing, immunotherapy for mismatch repair-deficient disease, ctDNA-guided treatment and organ preservation](https://onco.cc/roadmaps/colorectal-roadmap/)
- ideas: [Find peritoneal spread while it is still small, and run complete cytoreduction through networks rather than adding heated chemotherapy](https://onco.cc/ideas/idea-crc-peritoneal-disease-found-early-and-treated-in-networks/)

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