Last Updated: April 2, 2007

Verified by: Wuhan University, April 2007

Clinical Trial Phase: Phase 2 | Start Date: March 2007

Overall Status: Recruiting

Estimated Enrollment: 60

Brief Summary

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”

Condition Keyword(s):

• Stomach Neoplasms
• Colorectal Neoplasms
• Neoplasm Metastasis
• Mesothelioma

Intervention(s):

• Procedure: intraoperative peritoneal hyperthermic chemotherapy

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Detailed 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

Outcome Measures for this Clinical Trial

Primary:

• survival time
• time to treatment failure

Secondary:

• perioperative morbidity and mortality

Criteria for Participation in this Clinical Trial

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

Clinical Trials Locations, Contact Details, and Sponsors

Lead Sponsor: Wuhan University

Cancer Center of Wuhan University & Department of Oncology, Zhongnan Hospital of Wuhan University

Wuhan Hubei 430071 China

Overall Clinical Trial Officials and Contacts

Yan Li, M.D., Ph.D Principal Investigator Cancer Center of Wuhan University

Overall Contact: Yan Li, M.D., Ph.D +86-27-62337478 liyansd2@163.com

Additional Information

Information obtained from ClinicalTrials.gov on April 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00454519

Study ID Number: WUCC-0701

ClinicalTrials.gov Identifier: NCT00454519

Health Authority: China: Ministry of Health

Clinical Trials Authorship and Review

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

Labels: ClinicalTrial