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

This study is currently recruiting participants.
Verified by Wuhan University, June 2008

Sponsors and Collaborators: Wuhan University
NPO Organization to Support Peritoneal Dissemination Treatment
Kishiwada Tokushukai Hospital
Kusatsu General Hopital
Ikeda Hospital
Information provided by: Wuhan University
ClinicalTrials.gov Identifier: NCT00454519
  Purpose

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

MedlinePlus related topics:   Cancer    Colorectal Cancer    Fever    Mesothelioma    Stomach Cancer   

Drug Information available for:   Cisplatin    Mitomycin    Mitomycins   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Wuhan University:

Primary Outcome Measures:
  • overall survival time [ Time Frame: from operation to death due to cancer recurrence ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • perioperative morbidity and mortality [ Time Frame: Within 30 days postoperation ] [ Designated as safety issue: Yes ]

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
A: Experimental
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
B: Active Comparator
cytoreductive surgery alone, postoperative chemotherapy.
Procedure: cytoreductive surgery

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
  Eligibility
Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454519

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


Responsible Party:   Cancer Center of Wuhan University ( Prof. Yan Li, M.D., Ph.D )
Study ID Numbers:   WUCC-0701
First Received:   March 29, 2007
Last Updated:   June 11, 2008
ClinicalTrials.gov Identifier:   NCT00454519
Health Authority:   China: Ministry of Health

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

Study placed in the following topic categories:
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Stomach cancer
Intestinal Diseases
Mitomycins
Rectal Diseases
Intestinal Neoplasms
Carcinoma
Fever
Stomach Diseases
Digestive System Diseases
Cisplatin
Stomach Neoplasms
Mitomycin
Neoplasm Metastasis
Mesothelioma
Gastrointestinal Neoplasms
Adenoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Neoplasms, Mesothelial
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antibiotics, Antineoplastic
Pharmacologic Actions
Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Radiation-Sensitizing Agents
Therapeutic Uses
Alkylating Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 20, 2008




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