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

Study Description

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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

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Study Type :	Interventional (Clinical Trial)
Estimated 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 :	March 2007
Estimated Primary Completion Date :	December 2009

Arms and Interventions

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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 Name: 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

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Primary Outcome Measures :

1. overall survival time [ Time Frame: from operation to death due to cancer recurrence ]

Secondary Outcome Measures :

1. perioperative morbidity and mortality [ Time Frame: Within 30 days postoperation ]

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Contacts

Contact: Yan Li, M.D., Ph.D	+86-27-62337478	liyansd2@163.com

Locations

China, Hubei
Cancer Center of Wuhan University & Department of Oncology, Zhongnan Hospital of Wuhan University	Recruiting
Wuhan, Hubei, China, 430071
Contact: Yan Li, M.D., Ph.D +86-27-67813152 ext 3152 liyansd2@163.com
Contact: Yonemura Yutaka, M.D., Ph.D +81-072-433-2131 y.yonemura@coda.ocn.ne.jp
Sub-Investigator: Guo-Liang Yang, M.D
Sub-Investigator: Fu-Lin Cheng, M.D.
Principal Investigator: Yan Li, M.D., Ph.D
Sub-Investigator: Mao-Hui Feng, M.D., Ph.D
Sub-Investigator: Shibo Masaya, M.D.

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

More Information

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Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wu HT, Yang XJ, Huang CQ, Sun JH, Ji ZH, Peng KW, Zhang Q, Li Y. Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy with lobaplatin and docetaxel improves survival for patients with peritoneal carcinomatosis from abdominal and pelvic malignancies. World J Surg Oncol. 2016 Sep 15;14(1):246. doi: 10.1186/s12957-016-1004-4.

Responsible Party:	Prof. Yan Li, M.D., Ph.D, Cancer Center of Wuhan University
ClinicalTrials.gov Identifier:	NCT00454519 History of Changes
Other Study ID Numbers:	WUCC-0701
First Posted:	March 30, 2007
Last Update Posted:	February 13, 2009
Last Verified:	February 2009

Keywords provided by Wuhan University:

peritoneal carcinomatosis; cisplatin; mitomycin; gastric cancer; colorectal cancer

Additional relevant MeSH terms:

Neoplasms; Mesothelioma; Colorectal Neoplasms; Neoplasm Metastasis; Carcinoma; Stomach Neoplasms; Fever; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site	Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Stomach Diseases; Body Temperature Changes; Signs and Symptoms; Cisplatin; Mitomycins; Mitomycin; Antineoplastic Agents; Antibiotics, Antineoplastic