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

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ClinicalTrials.gov Identifier: NCT00454519
Recruitment Status : Unknown
Verified February 2009 by Wuhan University.
Recruitment status was:  Recruiting
First Posted : March 30, 2007
Last Update Posted : February 13, 2009
Sponsor:
Collaborators:
NPO Organization to Support Peritoneal Dissemination Treatment
Kishiwada Tokushukai Hospital
Kusatsu General Hopital
Ikeda Hospital
Information provided by:
Wuhan University

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

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, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Publications:

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

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    Key Record Dates
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