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| Sponsors and Collaborators: |
Wuhan University NPO Organization to Support Peritoneal Dissemination Treatment Kishiwada Tokushukai Hospital Kusatsu General Hopital Ikeda Hospital |
| Information provided by: | Wuhan University |
| ClinicalTrials.gov Identifier: | NCT00454519 |
Purpose
OBJECTIVES:
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.
| Condition | Intervention | Phase |
|
Stomach Neoplasms Colorectal Neoplasms Neoplasm Metastasis Mesothelioma |
Procedure: cytoreductive surgery Procedure: intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin |
Phase II |
| MedlinePlus related topics: | Cancer Colorectal Cancer Fever Mesothelioma Stomach Cancer |
| Drug Information available for: | Cisplatin Mitomycin Mitomycins |
| 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 |
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2007 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
A: Experimental
cytoreductive surgery, IPHC, cisplatin 20 mg/m2/L, Mitomycin C 4 mg/m2/L, postoperative chemotherapy.
|
Procedure: intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin |
|
B: Active Comparator
cytoreductive surgery alone, postoperative chemotherapy.
|
Procedure: cytoreductive surgery |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
- 20 to 70 years old
Performance status:
- KPS>50
Life expectancy:
- More than 8 weeks
Hematopoietic:
Hepatic:
Renal:
- Creatinine no greater than 1.5 mg/dL
Cardiovascular:
Pulmonary:
Other:
Eligibility
| Ages Eligible for Study: | 20 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 +86-27-67813152 ext 3152 liyansd2@163.com | |||||
| Contact: Yonemura Yutaka, M.D., Ph.D +81-072-433-2131 y.yonemura@coda.ocn.ne.jp | |||||
| 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 | |||||
| Sub-Investigator: Shibo Masaya, M.D. | |||||
| Wuhan University |
| NPO Organization to Support Peritoneal Dissemination Treatment |
| Kishiwada Tokushukai Hospital |
| Kusatsu General Hopital |
| Ikeda Hospital |
| Principal Investigator: | Yan Li, M.D., Ph.D | Cancer Center of Wuhan University |
| Principal Investigator: | Yonemura Yutaka, MD, PhD | NPO Organization to Support Peritoneal Dissemination Treatment |
More Information
| Responsible Party: | Cancer Center of Wuhan University ( Prof. Yan Li, M.D., Ph.D ) |
| Study ID Numbers: | WUCC-0701 |
| First Received: | March 29, 2007 |
| Last Updated: | June 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00454519 |
| Health Authority: | China: Ministry of Health |
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