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

NCT00454519 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2009-02-13

No results posted yet for this study

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.

Conditions

  • Stomach Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Mesothelioma

Interventions

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.

Sponsors & Collaborators

  • NPO Organization to Support Peritoneal Dissemination Treatment

    collaborator UNKNOWN

  • Kishiwada Tokushukai Hospital

    collaborator OTHER

  • Kusatsu General Hopital

    collaborator UNKNOWN

  • Ikeda Hospital

    collaborator UNKNOWN

  • Wuhan University

    lead OTHER

Principal Investigators

  • Yan Li, M.D., Ph.D · Cancer Center of Wuhan University

  • Yonemura Yutaka, MD, PhD · NPO Organization to Support Peritoneal Dissemination Treatment

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2009-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00454519 on ClinicalTrials.gov