A Multi-Center, Open-Label, Randomized Phase II Trial to Evaluate Hematologic Toxicities After HIPEC With Oxaliplatin or Mitomycin C in Patients With Appendiceal Tumors
I. To compare the toxicity profiles within 4 weeks of surgery of oxaliplatin and mitomycin C
delivered via Hyperthermic Intraperitoneal Chemotherapy in patients with peritoneal surface
malignancies from primary appendiceal tumors.
I. To compare the time to progression in patients treated with oxaliplatin vs. mitomycin C
delivered via Hyperthermic Intraperitoneal Chemotherapy for surface malignancies from
primary appendiceal tumors.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients undergo surgical cytoreduction and receive mitomycin C by hyperthermic
intraperitoneal chemotherapy (HIPEC).
Arm II: Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.
After completion of study treatment, patients are followed up at 6, 12, 18, 24, 30, and 36
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Difference in the rate of grade 3 or 4 hematologic toxicities (leukopenia, thrombocytopenia, and neutropenia) between the mitomycin C and oxaliplatin treatments
If a patient has a grade 3 or 4 standard hematologic toxicity (leukopenia, thrombocytopenia, and neutropenia), the patient will be considered to be an event. The observed rates of the 2 treatments will be the primary outcome, and the rates will be analyzed using a 2-sided chi-square test.
Within 4 weeks of surgery
Comprehensive Cancer Center of Wake Forest University
United States: Food and Drug Administration
|UPMC Hillman Cancer Center||Pittsburgh, Pennsylvania 15232|
|M D Anderson Cancer Center||Houston, Texas 77030|
|Wake Forest University Health Sciences||Winston-Salem, North Carolina 27157|