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

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ClinicalTrials.gov Identifier: NCT00769405
Recruitment Status : Completed
First Posted : October 9, 2008
Last Update Posted : August 30, 2016
Sponsor:
Information provided by (Responsible Party):
UNICANCER

Study Description
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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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Primary Peritoneal Cavity Cancer Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Procedure: hyperthermia treatment Phase 3

Detailed Description:

OBJECTIVES:

Primary

  • Compare overall survival of patients with peritoneal carcinoma of colorectal origin undergoing complete surgical resection and receiving systemic chemotherapy with versus without intraperitoneal chemohyperthermia.

Secondary

  • Evaluate recurrence-free survival of these patients.
  • Evaluate treatment toxicities.
  • Determine morbidity from surgical complications.
  • Determine prognostic factors of survival.

OUTLINE: This is a multicenter study. Patients are stratified according to participating center, residual tumor status (R0/R1 vs R2 ≤ 1 mm), prior regimens of systemic chemotherapy (first vs ≥ second), and preoperative systemic chemotherapy for metastatic disease (yes vs no). Patients are randomized to 1 of 2 treatment arms.

All patients undergo maximal surgical resection of the tumor.

  • Arm I: Patients 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/or after surgery). Patients must stop systemic chemotherapy at least 1 month before receiving intraperitoneal chemohyperthermia (CHIP). If bevacizumab is given as neoadjuvant therapy, then systemic chemotherapy must be discontinued 6 weeks before beginning CHIP. Patients undergo CHIP comprising oxaliplatin intraperitoneally during surgery and hyperthermia for 30 minutes.
  • Arm II: 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).

Tumor markers (ACE and CA 19-9) are assessed at baseline, at 1 month after surgery, and then at follow-up visits.

After completion of study therapy, patients are followed at 1 and 3 months, every 3 months for 3 years, and then every 6 months for 2 years.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2008
Actual Primary Completion Date : December 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I
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
Given IV

Drug: leucovorin calcium
Given IV

Drug: oxaliplatin
Given during surgery

Procedure: hyperthermia treatment
Given intraperitoneally during surgery
Experimental: Arm II
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
Given IV

Drug: leucovorin calcium
Given IV


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: until 3 years ]

Secondary Outcome Measures :
  1. Recurrence-free survival [ Time Frame: until 3 years ]
  2. Toxicity by NCI CTCAE v.3.0 [ Time Frame: until 5 years after surgery ]
  3. Morbidity from surgical complications (abdominal, extra-abdominal, aplasia) [ Time Frame: until 2 months after surgery ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00769405


Locations
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Sponsors and Collaborators
UNICANCER
Investigators
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Principal Investigator: Francois Quenet, MD Institut du Cancer de Montpellier - Val d'Aurelle
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT00769405    
Other Study ID Numbers: CDR0000595024
FRE-FNCLCC-ACCORD-15/0608
EUDRACT-2006-006175-20
EU-20847
First Posted: October 9, 2008    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016
Keywords provided by UNICANCER:
recurrent colon cancer
stage IV colon cancer
recurrent rectal cancer
stage IV rectal cancer
peritoneal carcinomatosis
Additional relevant MeSH terms:
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Colorectal Neoplasms
Carcinoma
Peritoneal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Abdominal Neoplasms
Peritoneal Diseases
Leucovorin
Fluorouracil
Oxaliplatin
Calcium
Levoleucovorin
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors