Surgery Plus Intraoperative Peritoneal Hyperthermic Chemotherapy (IPHC) to Treat Peritoneal Carcinomatosis

Study Overview
=================
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

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

Conditions
-----------------
Stomach Neoplasms, Colorectal Neoplasms, Neoplasm Metastasis, Mesothelioma

Intervention / Treatment
-----------------
* Procedure: cytoreductive surgery
* Procedure: intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>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<br>* 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.<br>* Other names: HIPEC;|
| Active Comparator: B<br>cytoreductive surgery alone, postoperative chemotherapy. | Procedure: cytoreductive surgery<br>* the whole abdominal-pelvic cavity is explored and maximal cytoreductive surgery is performed to remove visible tumor burden as much as possible.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival time |  | from operation to death due to cancer recurrence | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perioperative morbidity and mortality |  | Within 30 days postoperation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cisplatin, peritoneal carcinomatosis, mitomycin, gastric cancer, colorectal cancer