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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by Wuhan University.
Recruitment status was:  Recruiting
NPO Organization to Support Peritoneal Dissemination Treatment
Kishiwada Tokushukai Hospital
Kusatsu General Hopital
Ikeda Hospital
Information provided by:
Wuhan University Identifier:
First received: March 29, 2007
Last updated: February 12, 2009
Last verified: February 2009


  • 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 Intervention Phase
Stomach Neoplasms
Colorectal Neoplasms
Neoplasm Metastasis
Procedure: cytoreductive surgery
Procedure: intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Wuhan University:

Primary Outcome Measures:
  • overall survival time [ Time Frame: from operation to death due to cancer recurrence ]

Secondary Outcome Measures:
  • perioperative morbidity and mortality [ Time Frame: Within 30 days postoperation ]

Estimated Enrollment: 60
Study Start Date: March 2007
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:


  • 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



- 20 to 70 years old

Performance status:

- KPS>50

Life expectancy:

- More than 8 weeks


  • WBC at least 3,500/mm^3
  • Platelet count at least 80,000/mm^3


  • 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


- Creatinine no greater than 1.5 mg/dL


  • No significant irreversible cardiac ischemia
  • No significant changes in ECG recording


  • FEV_1 at least 1.2 liters
  • Maximum voluntary ventilation at least 50% expected


  • Not pregnant or nursing
  • Negative pregnancy test
  • No concurrent medical problems that would preclude surgery

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

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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Please refer to this study by its identifier: NCT00454519

China, Hubei
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
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prof. Yan Li, M.D., Ph.D, Cancer Center of Wuhan University Identifier: NCT00454519     History of Changes
Other Study ID Numbers: WUCC-0701 
Study First Received: March 29, 2007
Last Updated: February 12, 2009

Keywords provided by Wuhan University:
peritoneal carcinomatosis
gastric cancer
colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Stomach Neoplasms
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
Body Temperature Changes
Signs and Symptoms
Neoplastic Processes
Pathologic Processes
Stomach Diseases
Antineoplastic Agents
Antibiotics, Antineoplastic processed this record on February 20, 2017