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

March 29, 2007
February 12, 2009
March 2007
December 2009   (final data collection date for primary outcome measure)
overall survival time [ Time Frame: from operation to death due to cancer recurrence ] [ Designated as safety issue: Yes ]
  • survival time
  • time to treatment failure
Complete list of historical versions of study NCT00454519 on ClinicalTrials.gov Archive Site
perioperative morbidity and mortality [ Time Frame: Within 30 days postoperation ] [ Designated as safety issue: Yes ]
perioperative morbidity and mortality
Not Provided
Not Provided
 
Surgery Plus Intraoperative Peritoneal Hyperthermic Chemotherapy (IPHC) to Treat Peritoneal Carcinomatosis
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

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.

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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Stomach Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Mesothelioma
  • 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.
  • 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
  • Experimental: A
    cytoreductive surgery, IPHC, cisplatin 20 mg/m2/L, Mitomycin C 4 mg/m2/L, postoperative chemotherapy.
    Intervention: Procedure: intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin
  • Active Comparator: B
    cytoreductive surgery alone, postoperative chemotherapy.
    Intervention: Procedure: cytoreductive surgery
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. Epub 2008 Nov 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Not Provided
December 2009   (final data collection date for primary outcome measure)

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
Both
20 Years to 70 Years
No
Contact: Yan Li, M.D., Ph.D +86-27-62337478 liyansd2@163.com
China
 
NCT00454519
WUCC-0701
Yes
Prof. Yan Li, M.D., Ph.D, Cancer Center of Wuhan University
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
Wuhan University
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP