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

Colorectal Neoplasms Clinical Trial

Official title: 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 Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Mesothelioma
• Neoplasm Metastasis
• Neoplasms
• Stomach Neoplasms

• NCT number: NCT00454519
• Study type: Interventional
• Source: Wuhan University
• Contact: Yan Li, M.D., Ph.D
• Phone: +86-27-62337478
• Email: liyansd2@163.com
• Status: Recruiting
• Phase: Phase 2
• Start date: March 2007