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

NCT00769405 | Completed Phase 3

• 4 other identifiers: CDR0000595024FRE-FNCLCC-ACCORD-15/0608EUDRACT-2006-006175-20EU-20847
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

Colorectal Cancer; Primary Peritoneal Cavity Cancer

Keywords

recurrent colon cancer; stage IV colon cancer; recurrent rectal cancer; stage IV rectal cancer; peritoneal carcinomatosis

Outcome Measures

Primary Outcomes (1)

• Overall survival

  until 3 years

Secondary Outcomes (3)

• Recurrence-free survival

  until 3 years

• Toxicity by NCI CTCAE v.3.0

  until 5 years after surgery

• Morbidity from surgical complications (abdominal, extra-abdominal, aplasia)

  until 2 months after surgery

Study Arms (2)

Arm I

EXPERIMENTAL

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.

Drug: fluorouracil; Drug: leucovorin calcium; Drug: oxaliplatin; Procedure: hyperthermia treatment

Arm II

EXPERIMENTAL

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).

Drug: fluorouracil; Drug: leucovorin calcium

Interventions

fluorouracil DRUG

Given IV

Arm I; Arm II

leucovorin calcium DRUG

Given IV

Arm I; Arm II

oxaliplatin DRUG

Given during surgery

Arm I

hyperthermia treatment PROCEDURE

Given intraperitoneally during surgery

Arm I

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (20)

Centre Paul Papin

Angers, 49036, France

Location

Hôpital Antoine Béclère

Clamart, 92141, France

Location

CHU Estaing

Clermont-Ferrand, 63003, France

Location

Louis Mourier Hospital

Colombes, 92701, France

Location

Hopital Du Bocage

Dijon, 21034, France

Location

CHU de Grenoble - Hopital de la Tronche

Grenoble, 38043, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

Centre Regional Rene Gauducheau

Nantes-Saint Herblain, 44805, France

Location

Hopital de l'Archet CHU de Nice

Nice, F-06202, France

Location

Institut Curie

Paris, 75005, France

Location

Hopital Lariboisiere

Paris, 75010, France

Location

Hôpital Lariboisière

Paris, 75010, France

Location

Hopital Tenon

Paris, 75970, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

Hopital Universitaire Hautepierre

Strasbourg, 67098, France

Location

Centre Hospitalier Regional de Purpan

Toulouse, 31059, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Related Publications (1)

• 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.

  PMID: 33476595 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms; Peritoneal Neoplasms

Interventions

Fluorouracil; Leucovorin; Oxaliplatin; Diathermy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Abdominal Neoplasms; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals; Hyperthermia, Induced; Therapeutics

Study Officials

• Francois Quenet, MD

  Institut du Cancer de Montpellier - Val d'Aurelle

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2008
• First Posted: October 9, 2008
• Study Start: February 1, 2008
• Primary Completion: December 1, 2015
• Last Updated: August 30, 2016

Record last verified: 2016-08

Locations

FR (20)