Surgery Plus Intraoperative Peritoneal Hyperthermic Chemotherapy (IPHC) to Treat Peritoneal Carcinomatosis
IPHC
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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 29, 2007
CompletedFirst Posted
Study publicly available on registry
March 30, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedFebruary 13, 2009
February 1, 2009
2.8 years
March 29, 2007
February 12, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall survival time
from operation to death due to cancer recurrence
Secondary Outcomes (1)
perioperative morbidity and mortality
Within 30 days postoperation
Study Arms (2)
A
EXPERIMENTALcytoreductive surgery, IPHC, cisplatin 20 mg/m2/L, Mitomycin C 4 mg/m2/L, postoperative chemotherapy.
B
ACTIVE COMPARATORcytoreductive surgery alone, postoperative chemotherapy.
Interventions
the whole abdominal-pelvic cavity is explored and maximal cytoreductive surgery is performed to remove visible tumor burden as much as possible.
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.
Eligibility Criteria
You may qualify if:
- Gastric cancer or colorectal cancer with peritoneal carcinomatosis
- Gastric cancer or colorectal cancer with malignant ascites
- Karnofsky Performance Scale(KPS)\>50
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wuhan Universitylead
- NPO Organization to Support Peritoneal Dissemination Treatmentcollaborator
- Kishiwada Tokushukai Hospitalcollaborator
- Kusatsu General Hopitalcollaborator
- Ikeda Hospitalcollaborator
Study Sites (1)
Cancer Center of Wuhan University & Department of Oncology, Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071, China
Related Publications (3)
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.
PMID: 19018599BACKGROUNDZou D, Cai Y, Jin M, Zhang M, Liu Y, Chen S, Yang S, Zhang H, Zhu X, Huang C, Zhu Y, Miao X, Wei Y, Yang X, Tian J. A genetic variant in the immune-related gene ERAP1 affects colorectal cancer prognosis. Chin Med J (Engl). 2024 Feb 20;137(4):431-440. doi: 10.1097/CM9.0000000000002845. Epub 2023 Sep 8.
PMID: 37690994DERIVEDWu HT, Yang XJ, Huang CQ, Sun JH, Ji ZH, Peng KW, Zhang Q, Li Y. Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy with lobaplatin and docetaxel improves survival for patients with peritoneal carcinomatosis from abdominal and pelvic malignancies. World J Surg Oncol. 2016 Sep 15;14(1):246. doi: 10.1186/s12957-016-1004-4.
PMID: 27633880DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 29, 2007
First Posted
March 30, 2007
Study Start
March 1, 2007
Primary Completion
December 1, 2009
Last Updated
February 13, 2009
Record last verified: 2009-02