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

Colorectal Neoplasms Clinical Trial

— IPHC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00454519
• Other study ID #: WUCC-0701
• Status: Recruiting
• Phase: Phase 2
• First received: March 29, 2007
• Last updated: February 12, 2009
• Start date: March 2007

Study information

• Verified date: February 2009
• Source: Wuhan University
• Contact: Yan Li, M.D., Ph.D
• Phone: +86-27-62337478
• Email: liyansd2[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Mesothelioma
• Neoplasm Metastasis
• Neoplasms
• Stomach Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Cancer Center of Wuhan University & Department of Oncology, Zhongnan Hospital of Wuhan University	Wuhan	Hubei

Sponsors (5)

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

Country where clinical trial is conducted

China, 

References & Publications (1)

Yang XJ, Li Y, al-shammaa Hassan AH, Yang GL, Liu SY, Lu YL, Zhang JW, Yonemura Y. Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy improves survival in selected patients with peritoneal carcinomatosis from abdominal and pelvic malignancies: results of 21 cases. Ann Surg Oncol. 2009 Feb;16(2):345-51. doi: 10.1245/s10434-008-0226-2. Epub 2008 Nov 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival time		from operation to death due to cancer recurrence	Yes
Secondary	perioperative morbidity and mortality		Within 30 days postoperation	Yes