Systemic Chemotherapy With or Without Intraperitoneal Chemohyperthermia in Treating Patients Undergoing Surgery for Peritoneal Carcinomatosis From Colorectal Cancer
Condition: Colorectal Cancer; Primary Peritoneal Cavity Cancer
MeSH terms: Colorectal Neoplasms; Carcinoma; Peritoneal Neoplasms
Study type: Interventional
Phase: Phase 3

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.
    

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.
    

Intervention name(s): fluorouracil; leucovorin calcium; oxaliplatin; hyperthermia treatment
Intervention type(s): Drug; Drug; Drug; Procedure
Intervention description(s): Given IV; Given IV; Given during surgery; Given intraperitoneally during surgery
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin; Calcium; Levoleucovorin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent colon cancer; stage IV colon cancer; recurrent rectal cancer; stage IV rectal cancer; peritoneal carcinomatosis