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| Name | Class |
|---|---|
| NPO Organization to Support Peritoneal Dissemination Treatment | UNKNOWN |
| Kishiwada Tokushukai Hospital | OTHER |
| Kusatsu General Hopital | UNKNOWN |
| Ikeda Hospital |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | cytoreductive surgery, IPHC, cisplatin 20 mg/m2/L, Mitomycin C 4 mg/m2/L, postoperative chemotherapy. |
|
| B | Active Comparator | cytoreductive surgery alone, postoperative chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cytoreductive surgery | Procedure | the whole abdominal-pelvic cavity is explored and maximal cytoreductive surgery is performed to remove visible tumor burden as much as possible. |
|
| Measure | Description | Time Frame |
|---|---|---|
| overall survival time | from operation to death due to cancer recurrence |
| Measure | Description | Time Frame |
|---|---|---|
| perioperative morbidity and mortality | Within 30 days postoperation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Li, M.D., Ph.D | Contact | +86-27-62337478 | liyansd2@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yan Li, M.D., Ph.D | Cancer Center of Wuhan University | Principal Investigator |
| Yonemura Yutaka, MD, PhD | NPO Organization to Support Peritoneal Dissemination Treatment | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Center of Wuhan University & Department of Oncology, Zhongnan Hospital of Wuhan University | Recruiting | Wuhan | Hubei | 430071 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19018599 | Background | Yang XJ, Li Y, al-shammaa Hassan AH, Yang GL, Liu SY, Lu YL, Zhang JW, Yonemura Y. Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy improves survival in selected patients with peritoneal carcinomatosis from abdominal and pelvic malignancies: results of 21 cases. Ann Surg Oncol. 2009 Feb;16(2):345-51. doi: 10.1245/s10434-008-0226-2. Epub 2008 Nov 19. | |
| 37690994 |
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| UNKNOWN |
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| intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin | Procedure | 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. |
|
|
| Derived |
| Zou D, Cai Y, Jin M, Zhang M, Liu Y, Chen S, Yang S, Zhang H, Zhu X, Huang C, Zhu Y, Miao X, Wei Y, Yang X, Tian J. A genetic variant in the immune-related gene ERAP1 affects colorectal cancer prognosis. Chin Med J (Engl). 2024 Feb 20;137(4):431-440. doi: 10.1097/CM9.0000000000002845. Epub 2023 Sep 8. |
| 27633880 | Derived | Wu HT, Yang XJ, Huang CQ, Sun JH, Ji ZH, Peng KW, Zhang Q, Li Y. Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy with lobaplatin and docetaxel improves survival for patients with peritoneal carcinomatosis from abdominal and pelvic malignancies. World J Surg Oncol. 2016 Sep 15;14(1):246. doi: 10.1186/s12957-016-1004-4. |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D015179 | Colorectal Neoplasms |
| D009362 | Neoplasm Metastasis |
| D008654 | Mesothelioma |
| D010534 | Peritoneal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018301 | Neoplasms, Mesothelial |
| D000008 | Abdominal Neoplasms |
| D010532 | Peritoneal Diseases |
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| ID | Term |
|---|---|
| D065426 | Cytoreduction Surgical Procedures |
| D002945 | Cisplatin |
| D016685 | Mitomycin |
| D000084262 | Hyperthermic Intraperitoneal Chemotherapy |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D008937 | Mitomycins |
| D045563 | Indolequinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
| D001389 | Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D017024 | Chemotherapy, Adjuvant |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D006979 | Hyperthermia, Induced |
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