Clinical trial · Interventional

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

Phase III Study Evaluating the Use of Systemic Chemotherapy and Chemohyperthemia Intraperitoneal Preoperatively (CHIP) and After Maximum Resection of Peritoneal Carcinomatosis Originating With Colorectal Cancer

NCT00769405CI-TRIAL-00023713completedPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Colorectal Cancer	Malignant Colorectal Neoplasm	CURATED_BROADER	0.80
Primary Peritoneal Cavity Cancer	—	UNRESOLVED	—

Interventions

Interventions (4)

Intervention	Type	Mapped drug	Match
fluorouracil	Drug	Fluorouracil	ALIAS
hyperthermia treatment	Procedure	—	UNRESOLVED
leucovorin calcium	Drug	Leucovorin	ALIAS
oxaliplatin	Drug	Oxaliplatin	ALIAS

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Arm I
description
Patients undergo surgery and receive standard systemic chemotherapy comprising leucovorin calcium IV followed by fluorouracil IV over 30 minutes. Systemic chemotherapy will continue for at least 6 months (before and after surgery). Patients also undergo CHIP comprising oxaliplatin intraperitoneally during surgery and hyperthermia for 30 minutes.
interventionNames
1. Drug: fluorouracil
2. Drug: leucovorin calcium
3. Drug: oxaliplatin
4. Procedure: hyperthermia treatment
type
EXPERIMENTAL
label
Arm II
description
Patients undergo surgery and receive standard systemic chemotherapy comprising leucovorin calcium IV followed by fluorouracil IV over 30 minutes. Systemic chemotherapy will continue for at least 6 months (before and after surgery).
interventionNames
1. Drug: fluorouracil
2. Drug: leucovorin calcium

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 70 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Histologically confirmed colorectal cancer

  * Peritoneal carcinoma extension ≤ 25 (Sugarbaker Index) (determined intraoperatively)

    * Planning to receive standard systemic chemotherapy

      * Chemotherapy for metastatic cancer should be initiated 3 months after surgery
    * No extraperitoneal metastases, including liver and lung metastasis
    * No carcinomatosis of other origin besides colorectal, in particular appendical carcinomatosis
* Macroscopically complete resection (R1) or surgical reduction of tumor to a residual thickness ≤ 1 mm (R2) is possible

PATIENT CHARACTERISTICS:

* WHO performance status 0-1
* Life expectancy \> 12 weeks
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST and ALT ≤ 3 times ULN
* Alkaline phosphatase ≤ 3 times ULN
* Creatinine ≤ 1.25 times ULN
* Eligible for surgery
* No peripheral neuropathy \> grade 3
* Not pregnant or nursing
* No other cancer in the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
* No inability to submit to follow-up medical testing for geographical, social, or psychological reasons
* Affiliated with a social security program
* Not deprived of liberty or under supervision

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior chemohyperthermia
* No concurrent participation in another study of first-line therapy for this cancer

References

Publications (1)

DERIVEDQuenet 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. PMID 33476595

Registry

Dates and enrollment

Start: Feb 1, 2008
Primary completion: Dec 1, 2015
Completion: —
First posted: Oct 9, 2008
Last update posted: Aug 30, 2016
Enrollment: 264 (actual)
Lead sponsor: UNICANCER OTHER
Keywords: recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer, peritoneal carcinomatosis

Data updated 22 days agoSource updated Aug 30, 2016source: clinicaltrials

Locations

Locations by country (20)

Country	Sites	Recruiting
France	20	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.