Mesothelioma Related Clinical Trials:
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
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Status: Recruiting
Sponsors and Collaborators: Wuhan University
Information provided by: Wuhan University
Government Identifier: NCT00454519
Condition: Stomach Neoplasms; Colorectal Neoplasms; Neoplasm Metastasis; Mesothelioma
Intervention: Procedure: intraoperative peritoneal hyperthermic chemotherapy
Purpose:
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 |
| 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 |
- survival time
- time to treatment failure
- perioperative morbidity and mortality
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2007 |
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
Eligibility:
| Ages Eligible for Study: | 20 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations:
Please refer to this study by its ClinicalTrials.gov identifier: NCT00454519Contacts
| Contact: Yan Li, M.D., Ph.D | +86-27-62337478 | liyansd2@163.com |
| China, Hubei | |||||
| Cancer Center of Wuhan University & Department of Oncology, Zhongnan Hospital of Wuhan University | Recruiting | ||||
| Wuhan, Hubei, China, 430071 | |||||
| Contact: Yan Li, M.D., Ph.D +86-27-62337478 liyansd2@163.com | |||||
| Sub-Investigator: Guo-Liang Yang, M.D | |||||
| Sub-Investigator: Fu-Lin Cheng, M.D. | |||||
| Principal Investigator: Yan Li, M.D., Ph.D | |||||
| Sub-Investigator: Mao-Hui Feng, M.D., Ph.D | |||||
Sponsors and Collaborators
| Wuhan University |
Investigators
| Principal Investigator: | Yan Li, M.D., Ph.D | Cancer Center of Wuhan University |
Additional Information:
| Study ID Numbers: | WUCC-0701 |
| First Received: | March 29, 2007 |
| Last Updated: | April 2, 2007 |
| ClinicalTrials.gov Identifier: | NCT00454519 |
| Health Authority: | China: Ministry of Health |
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