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

Sponsor

Wuhan University (Other)

Overall Status

Unknown status

CT.gov ID

NCT00454519

Collaborator

NPO Organization to Support Peritoneal Dissemination Treatment (Other), Kishiwada Tokushukai Hospital (Other), Kusatsu General Hopital (Other), Ikeda Hospital (Other)

Enrollment

Location

Arms

Study Details

Study Description

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.

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

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 :

Mar 1, 2007

Anticipated Primary Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A 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 Names: 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.

Arm

Intervention/Treatment

Experimental: A

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 Names:

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.

Outcome Measures

Primary Outcome Measures

overall survival time [from operation to death due to cancer recurrence]

Secondary Outcome Measures

perioperative morbidity and mortality [Within 30 days postoperation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Center of Wuhan University & Department of Oncology, Zhongnan Hospital of Wuhan University	Wuhan	Hubei	China	430071

Sponsors and Collaborators

Wuhan University
NPO Organization to Support Peritoneal Dissemination Treatment
Kishiwada Tokushukai Hospital
Kusatsu General Hopital
Ikeda Hospital

Investigators

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