Surgery Plus Intraoperative Peritoneal Hyperthermic Chemotherapy (IPHC) to Treat Peritoneal Carcinomatosis (IPHC)
Primary Purpose
Stomach Neoplasms, Colorectal Neoplasms, Neoplasm Metastasis
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
cytoreductive surgery
intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Neoplasms focused on measuring peritoneal carcinomatosis, cisplatin, mitomycin, gastric cancer, colorectal cancer
Eligibility 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
Sites / Locations
- Cancer Center of Wuhan University & Department of Oncology, Zhongnan Hospital of Wuhan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
cytoreductive surgery, IPHC, cisplatin 20 mg/m2/L, Mitomycin C 4 mg/m2/L, postoperative chemotherapy.
cytoreductive surgery alone, postoperative chemotherapy.
Outcomes
Primary Outcome Measures
overall survival time
Secondary Outcome Measures
perioperative morbidity and mortality
Full Information
NCT ID
NCT00454519
First Posted
March 29, 2007
Last Updated
February 12, 2009
Sponsor
Wuhan University
Collaborators
NPO Organization to Support Peritoneal Dissemination Treatment, Kishiwada Tokushukai Hospital, Kusatsu General Hopital, Ikeda Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00454519
Brief Title
Surgery Plus Intraoperative Peritoneal Hyperthermic Chemotherapy (IPHC) to Treat Peritoneal Carcinomatosis
Acronym
IPHC
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 Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2007 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Wuhan University
Collaborators
NPO Organization to Support Peritoneal Dissemination Treatment, Kishiwada Tokushukai Hospital, Kusatsu General Hopital, Ikeda Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms, Colorectal Neoplasms, Neoplasm Metastasis, Mesothelioma
Keywords
peritoneal carcinomatosis, cisplatin, mitomycin, gastric cancer, colorectal cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
cytoreductive surgery, IPHC, cisplatin 20 mg/m2/L, Mitomycin C 4 mg/m2/L, postoperative chemotherapy.
Arm Title
B
Arm Type
Active Comparator
Arm Description
cytoreductive surgery alone, postoperative chemotherapy.
Intervention Type
Procedure
Intervention Name(s)
cytoreductive surgery
Intervention Description
the whole abdominal-pelvic cavity is explored and maximal cytoreductive surgery is performed to remove visible tumor burden as much as possible.
Intervention Type
Procedure
Intervention Name(s)
intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin
Other Intervention Name(s)
HIPEC
Intervention Description
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.
Primary Outcome Measure Information:
Title
overall survival time
Time Frame
from operation to death due to cancer recurrence
Secondary Outcome Measure Information:
Title
perioperative morbidity and mortality
Time Frame
Within 30 days postoperation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Li, M.D., Ph.D
Phone
+86-27-62337478
Email
liyansd2@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Li, M.D., Ph.D
Organizational Affiliation
Cancer Center of Wuhan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yonemura Yutaka, MD, PhD
Organizational Affiliation
NPO Organization to Support Peritoneal Dissemination Treatment
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Center of Wuhan University & Department of Oncology, Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430071
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Li, M.D., Ph.D
Phone
+86-27-67813152
Ext
3152
Email
liyansd2@163.com
First Name & Middle Initial & Last Name & Degree
Yonemura Yutaka, M.D., Ph.D
Phone
+81-072-433-2131
Email
y.yonemura@coda.ocn.ne.jp
First Name & Middle Initial & Last Name & Degree
Guo-Liang Yang, M.D
First Name & Middle Initial & Last Name & Degree
Fu-Lin Cheng, M.D.
First Name & Middle Initial & Last Name & Degree
Yan Li, M.D., Ph.D
First Name & Middle Initial & Last Name & Degree
Mao-Hui Feng, M.D., Ph.D
First Name & Middle Initial & Last Name & Degree
Shibo Masaya, M.D.
12. IPD Sharing Statement
Citations:
PubMed Identifier
19018599
Citation
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.
Results Reference
background
PubMed Identifier
27633880
Citation
Wu 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.
Results Reference
derived
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Surgery Plus Intraoperative Peritoneal Hyperthermic Chemotherapy (IPHC) to Treat Peritoneal Carcinomatosis
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