Systemic Chemotherapy With or Without Intraperitoneal Chemohyperthermia in Treating Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer

Summary

RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether systemic chemotherapy is more effective with or without intraperitoneal chemohyperthermia in treating patients with peritoneal carcinomatosis from colorectal cancer. PURPOSE: This randomized phase III trial is studying systemic chemotherapy to see how well it works compared with or without intraperitoneal chemohyperthermia in treating patients undergoing surgery for peritoneal carcinomatosis from colorectal cancer.

Timeline

Start

2008-02

Primary completion

2015-12

Completion

—

Outcome

Missed primary endpoint

paper hazard ratio 1·00 [95·37% CI 0·63-1·58]; stratified log-rank p=0·99 PMID 33476595 ↗

paper Considering the absence of an overall survival benefit after adding HIPEC to cytoreductive surgery PMID 33476595 ↗

Publications

• Quenet F, Elias D, Roca L, Goere D, Ghouti L, Pocard M, Facy O, Arvieux C, Lorimier G, Pezet D, Marchal F, Loi V, Meeus P, Juzyna B, de Forges H, Paineau J, Glehen O; UNICANCER-GI Group and BIG Renape Group. Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy versus cytoreductive surgery alone for colorectal peritoneal metastases (PRODIGE 7): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Feb;22(2):256-266. doi: 10.1016/S1470-2045(20)30599-4. Epub 2021 Jan 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Oxaliplatin	Small molecule	360 mg/m2	Intravenous
Subject	Oxaliplatin	Small molecule	460 mg/m2	Intravenous
Background	Leucovorin	Small molecule	20 mg/m2	Intravenous
Background	fluorouracil	Small molecule	400 mg/m2	Intravenous

Indications