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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Wuhan University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
NPO Organization to Support Peritoneal Dissemination Treatment
Kishiwada Tokushukai Hospital
Kusatsu General Hopital
Ikeda Hospital
Information provided by:
Wuhan University
ClinicalTrials.gov Identifier:
NCT00454519
First received: March 29, 2007
Last updated: February 12, 2009
Last verified: February 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 ] [ 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
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:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
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
Study First Received: March 29, 2007
Last Updated: February 12, 2009
Health Authority: China: Ministry of Health

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

Additional relevant MeSH terms:
Neoplasms
Mesothelioma
Neoplasms, Mesothelial
Colorectal Neoplasms
Neoplasm Metastasis
Stomach Neoplasms
Fever
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014