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| Sponsor: | Wuhan University |
|---|---|
| Collaborators: |
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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
|---|---|
|
Experimental: A
cytoreductive surgery, IPHC, cisplatin 20 mg/m2/L, Mitomycin C 4 mg/m2/L, postoperative chemotherapy.
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Procedure: intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin
Immediately after the cytoreductive surgery, cisplatin and mitomycin C dissolved in 12,000 ml of normal saline heated to 42 degrees celsius is infused into the abdominal cavity for a sustained hyperthermic intraperitoneal chemotherapy for 60 to 90 minutes.
Other Name: HIPEC
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Active Comparator: B
cytoreductive surgery alone, postoperative chemotherapy.
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Procedure: cytoreductive surgery
the whole abdominal-pelvic cavity is explored and maximal cytoreductive surgery is performed to remove visible tumor burden as much as possible.
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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. | |
| 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: | Prof. Yan Li, M.D., Ph.D, Cancer Center of Wuhan University |
| ClinicalTrials.gov Identifier: | NCT00454519 History of Changes |
| Other Study ID Numbers: | WUCC-0701 |
| Study First Received: | March 29, 2007 |
| Last Updated: | February 12, 2009 |
| Health Authority: | China: Ministry of Health |
|
peritoneal carcinomatosis cisplatin mitomycin gastric cancer colorectal cancer |
|
Neoplasms Colorectal Neoplasms Fever Stomach Neoplasms Mesothelioma Neoplasm Metastasis Carcinoma Gastrointestinal Neoplasms Intestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
Rectal Diseases Body Temperature Changes Signs and Symptoms Stomach Diseases Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Mesothelial Neoplastic Processes Pathologic Processes Mitomycins Mitomycin Cisplatin Antibiotics, Antineoplastic Antineoplastic Agents |