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

Wuhan University

Status and phase: Unknown; Phase 2

Conditions: Neoplasm Metastasis; Mesothelioma; Colorectal Neoplasms; Stomach Neoplasms

Treatments: Procedure: intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin; Procedure: cytoreductive surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT00454519

WUCC-0701

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gastric cancer or colorectal cancer with peritoneal carcinomatosis
• Gastric cancer or colorectal cancer with malignant ascites
• Karnofsky Performance Scale(KPS)>50

Exclusion criteria

• Age less than 20 years old, or beyond 70 years old
• Any lung metastasis, liver metastasis, or prominent retroperitoneal lymph node metastasis
• Bilirubin greater than 3 times upper limit of normal (ULN)
• AST and ALT greater than 5 times ULN
• Liver enzymes greater than 3 times ULN

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

A

Experimental group

Description:

cytoreductive surgery, IPHC, cisplatin 20 mg/m2/L, Mitomycin C 4 mg/m2/L, postoperative chemotherapy.

Treatment:

Procedure: intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin

B

Active Comparator group

Description:

cytoreductive surgery alone, postoperative chemotherapy.

Treatment:

Procedure: cytoreductive surgery