NCT00454519

Surgery Plus Intraoperative Peritoneal Hyperthermic Chemotherapy (IPHC) to Treat Peritoneal Carcinomatosis

Cytoreductive Surgery Plus Intraoperative Peritoneal Hyperthermic Chemotherapy for the Treatment of Peritoneal Carcinomatosis From Gastrointestinal Cancer: an Open Label, Randomized, Prospective, Phase 2 Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Wuhan University · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

OBJECTIVES: * Determine response and survival of patients with peritoneal carcinomatosis treated with cytoreductive surgery plus intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin * Assess the quality of life of patients treated with this regimen. OUTLINE: Patients are randomized into IPHC group and control group. In the former group, the patients undergo cytoreductive surgery plus intraoperative hyperthermic peritoneal perfusion with cisplatin and mitomycin over 60 minutes. Patients in the control group just underwent routine cytoreductive surgery. All patients in both groups receive the standard conventional chemotherapy after surgery. Quality of life is assessed at study initiation, at 1, 3, 6 months. Patients are followed at 4 weeks, every 3 months for 1 year, and then every 6 months for up to 3 years.

Detailed description

DISEASE CHARACTERISTICS: * Histologically confirmed peritoneal carcinomatosis with the following histologies: * Primary peritoneal mesothelioma * Adenocarcinoma of gastrointestinal tract origin * Confined to peritoneal cavity * Tumor mass could be debulked to less than 2.5 cm in diameter per tumor deposit * Must not have failed prior intraperitoneal platinum therapy * Treatment failure is defined as radiographic evidence of disease progression on 2 consecutive CT scans within 3 months after therapy PATIENT CHARACTERISTICS: Age: \- 20 to 70 years old Performance status: \- KPS\>50 Life expectancy: \- More than 8 weeks Hematopoietic: * WBC at least 3,500/mm\^3 * Platelet count at least 80,000/mm\^3 Hepatic: * Bilirubin no greater than 2 times upper limit of normal (ULN) * AST and ALT no greater than 2 times ULN * Liver enzymes no greater than 2 times ULN Renal: \- Creatinine no greater than 1.5 mg/dL Cardiovascular: * No significant irreversible cardiac ischemia * No significant changes in ECG recording Pulmonary: * FEV\_1 at least 1.2 liters * Maximum voluntary ventilation at least 50% expected Other: * Not pregnant or nursing * Negative pregnancy test * No concurrent medical problems that would preclude surgery

Conditions

• Stomach Neoplasms
• Colorectal Neoplasms
• Neoplasm Metastasis
• Mesothelioma

Interventions

Type	Name	Description
PROCEDURE	cytoreductive surgery	the whole abdominal-pelvic cavity is explored and maximal cytoreductive surgery is performed to remove visible tumor burden as much as possible.
PROCEDURE	intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin	Immediately after the cytoreductive surgery, cisplatin and mitomycin C dissolved in 12,000 ml of normal saline heated to 42 degrees celsius is infused into the abdominal cavity for a sustained hyperthermic intraperitoneal chemotherapy for 60 to 90 minutes.

Timeline

• Start date: 2007-03-01
• Primary completion: 2009-12-01
• First posted: 2007-03-30
• Last updated: 2009-02-13

Locations

1 site across 1 country: China