Surgery Plus Intraoperative Peritoneal Hyperthermic Chemotherapy (IPHC) to Treat Peritoneal Carcinomatosis
- Conditions
- Stomach NeoplasmsColorectal NeoplasmsNeoplasm MetastasisMesothelioma
- Interventions
- Procedure: intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycinProcedure: cytoreductive surgery
- Registration Number
- NCT00454519
- Lead Sponsor
- Wuhan University
- Brief 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- Gastric cancer or colorectal cancer with peritoneal carcinomatosis
- Gastric cancer or colorectal cancer with malignant ascites
- Karnofsky Performance Scale(KPS)>50
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin cytoreductive surgery, IPHC, cisplatin 20 mg/m2/L, Mitomycin C 4 mg/m2/L, postoperative chemotherapy. B cytoreductive surgery cytoreductive surgery alone, postoperative chemotherapy.
- Primary Outcome Measures
Name Time Method overall survival time from operation to death due to cancer recurrence
- Secondary Outcome Measures
Name Time Method perioperative morbidity and mortality Within 30 days postoperation
Trial Locations
- Locations (1)
Cancer Center of Wuhan University & Department of Oncology, Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China