Surgery Plus Intraoperative Peritoneal Hyperthermic Chemotherapy (IPHC) to Treat Peritoneal Carcinomatosis
Information source: Wuhan University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stomach Neoplasms; Colorectal Neoplasms; Neoplasm Metastasis; Mesothelioma
Intervention: cytoreductive surgery (Procedure); intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin (Procedure)
Phase: Phase 2
Status: Recruiting
Sponsored by: Wuhan University Official(s) and/or principal investigator(s): Yan Li, M.D., Ph.D, Principal Investigator, Affiliation: Cancer Center of Wuhan University Yonemura Yutaka, MD, PhD, Principal Investigator, Affiliation: NPO Organization to Support Peritoneal Dissemination Treatment
Overall contact: Yan Li, M.D., Ph.D, Phone: +86-27-62337478, Email: liyansd2@163.com
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: overall survival time
Secondary outcome: perioperative morbidity and mortality
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
Minimum age: 20 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Yan Li, M.D., Ph.D, Phone: +86-27-62337478, Email: liyansd2@163.com
Cancer Center of Wuhan University & Department of Oncology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei 430071, China; Recruiting Yan Li, M.D., Ph.D, Phone: +86-27-67813152, Ext: 3152, Email: liyansd2@163.com Yonemura Yutaka, M.D., Ph.D, Phone: +81-072-433-2131, Email: y.yonemura@coda.ocn.ne.jp Guo-Liang Yang, M.D, Sub-Investigator Fu-Lin Cheng, M.D., Sub-Investigator Yan Li, M.D., Ph.D, Principal Investigator Mao-Hui Feng, M.D., Ph.D, Sub-Investigator Shibo Masaya, M.D., Sub-Investigator
Additional Information
Related publications: 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. doi: 10.1245/s10434-008-0226-2. Epub 2008 Nov 19.
Starting date: March 2007
Last updated: February 12, 2009
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