Surgery Plus Intraoperative Peritoneal Hyperthermic Chemotherapy (IPHC) to Treat Peritoneal Carcinomatosis
NCT ID: NCT00454519
Last Updated: 2009-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2007-03-31
Brief Summary
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* 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.
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Detailed Description
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* 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
cytoreductive surgery, IPHC, cisplatin 20 mg/m2/L, Mitomycin C 4 mg/m2/L, postoperative chemotherapy.
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.
B
cytoreductive surgery alone, postoperative chemotherapy.
cytoreductive surgery
the whole abdominal-pelvic cavity is explored and maximal cytoreductive surgery is performed to remove visible tumor burden as much as possible.
Interventions
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cytoreductive surgery
the whole abdominal-pelvic cavity is explored and maximal cytoreductive surgery is performed to remove visible tumor burden as much as possible.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Gastric cancer or colorectal cancer with malignant ascites
* Karnofsky Performance Scale(KPS)\>50
Exclusion Criteria
* 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
20 Years
70 Years
ALL
No
Sponsors
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NPO Organization to Support Peritoneal Dissemination Treatment
UNKNOWN
Kishiwada Tokushukai Hospital
OTHER
Kusatsu General Hopital
UNKNOWN
Ikeda Hospital
UNKNOWN
Wuhan University
OTHER
Responsible Party
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Cancer Center of Wuhan University
Principal Investigators
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Yan Li, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Cancer Center of Wuhan University
Yonemura Yutaka, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
NPO Organization to Support Peritoneal Dissemination Treatment
Locations
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Cancer Center of Wuhan University & Department of Oncology, Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Other Identifiers
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WUCC-0701
Identifier Type: -
Identifier Source: org_study_id
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