Conditions: Carcinoma of the Appendix Primary Peritoneal Cavity Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 136
Healthy volunteers: no

Brief summary:
This randomized phase II trial is studying the side effects and how well giving oxaliplatin or mitomycin C directly into the abdomen after surgery works in treating patients with tumors of the appendix. Drugs used in chemotherapy, such as oxaliplatin and mitomycin C, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Heating a chemotherapy solution and infusing it directly into the abdomen may kill more tumor cells. Giving these treatments after surgery may kill any tumor cells that remain after surgery.

Detailed description:
PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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 months.

Arms:
arm 1: Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC. arm 2: Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.

Interventions: intervention 1: mitomycin C intervention 2: oxaliplatin intervention 3: therapeutic conventional surgery intervention 4: quality-of-life assessment intervention 5: hyperthermic intraperitoneal chemotherapy
Intervention descriptions: intervention 1: Given by HIPEC intervention 2: Given by HIPEC intervention 3: Undergo surgery intervention 4: Ancillary studies intervention 5: Undergo HIPEC

Protocol document: