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Trial Title:
Surgery Plus Intraoperative Peritoneal Hyperthermic Chemotherapy (IPHC) to Treat Peritoneal Carcinomatosis
NCT ID:
NCT00454519
Condition:
Stomach Neoplasms
Colorectal Neoplasms
Neoplasm Metastasis
Mesothelioma
Conditions: Official terms:
Neoplasms
Neoplasm Metastasis
Mesothelioma
Colorectal Neoplasms
Carcinoma
Peritoneal Neoplasms
Stomach Neoplasms
Mitomycins
Mitomycin
Conditions: Keywords:
peritoneal carcinomatosis
cisplatin
mitomycin
gastric cancer
colorectal cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
cytoreductive surgery
Description:
the whole abdominal-pelvic cavity is explored and maximal cytoreductive surgery is
performed to remove visible tumor burden as much as possible.
Arm group label:
B
Intervention type:
Procedure
Intervention name:
intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin
Description:
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.
Arm group label:
A
Other name:
HIPEC
Summary:
OBJECTIVES:
- 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.
Detailed description:
DISEASE CHARACTERISTICS:
- 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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Gastric cancer or colorectal cancer with peritoneal carcinomatosis
- Gastric cancer or colorectal cancer with malignant ascites
- Karnofsky Performance Scale(KPS)>50
Exclusion Criteria:
- Age less than 20 years old, or beyond 70 years old
- 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
Gender:
All
Minimum age:
20 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Center of Wuhan University & Department of Oncology, Zhongnan Hospital of Wuhan University
Address:
City:
Wuhan
Zip:
430071
Country:
China
Status:
Recruiting
Contact:
Last name:
Yan Li, M.D., Ph.D
Phone:
+86-27-67813152
Phone ext:
3152
Email:
liyansd2@163.com
Contact backup:
Last name:
Yonemura Yutaka, M.D., Ph.D
Phone:
+81-072-433-2131
Email:
y.yonemura@coda.ocn.ne.jp
Investigator:
Last name:
Guo-Liang Yang, M.D
Email:
Sub-Investigator
Investigator:
Last name:
Fu-Lin Cheng, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Yan Li, M.D., Ph.D
Email:
Principal Investigator
Investigator:
Last name:
Mao-Hui Feng, M.D., Ph.D
Email:
Sub-Investigator
Investigator:
Last name:
Shibo Masaya, M.D.
Email:
Sub-Investigator
Start date:
March 2007
Lead sponsor:
Agency:
Wuhan University
Agency class:
Other
Collaborator:
Agency:
NPO Organization to Support Peritoneal Dissemination Treatment
Agency class:
Other
Collaborator:
Agency:
Kishiwada Tokushukai Hospital
Agency class:
Other
Collaborator:
Agency:
Kusatsu General Hopital
Agency class:
Other
Collaborator:
Agency:
Ikeda Hospital
Agency class:
Other
Source:
Wuhan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00454519
