Surgery Plus Intraoperative Peritoneal Hyperthermic Chemotherapy (IPHC) to Treat Peritoneal Carcinomatosis (IPHC)
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|ClinicalTrials.gov Identifier: NCT00454519|
Recruitment Status : Unknown
Verified February 2009 by Wuhan University.
Recruitment status was: Recruiting
First Posted : March 30, 2007
Last Update Posted : February 13, 2009
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Stomach Neoplasms Colorectal Neoplasms Neoplasm Metastasis Mesothelioma||Procedure: cytoreductive surgery Procedure: intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin||Phase 2|
- 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
- 20 to 70 years old
- More than 8 weeks
- WBC at least 3,500/mm^3
- Platelet count at least 80,000/mm^3
- 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
- Creatinine no greater than 1.5 mg/dL
- No significant irreversible cardiac ischemia
- No significant changes in ECG recording
- FEV_1 at least 1.2 liters
- Maximum voluntary ventilation at least 50% expected
- Not pregnant or nursing
- Negative pregnancy test
- No concurrent medical problems that would preclude surgery
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2007|
|Estimated Primary Completion Date :||December 2009|
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
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
Active Comparator: B
cytoreductive surgery alone, postoperative chemotherapy.
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.
- overall survival time [ Time Frame: from operation to death due to cancer recurrence ]
- perioperative morbidity and mortality [ Time Frame: Within 30 days postoperation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00454519
|Contact: Yan Li, M.D., Ph.Dfirstname.lastname@example.org|
|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 email@example.com|
|Contact: Yonemura Yutaka, M.D., Ph.D +81-072-433-2131 firstname.lastname@example.org|
|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|