The role of intra-abdominal chemotherapy in inoperable gastric cancer to change to operable tumor in case-control study about one year survival and improve quality of life
The aim of this study is to investigate one year survival rate and improvement in quality of life in patients with inoperable gastric cancer whom undergo neoadjuvant intraperitoneal chemotherapy. A total of 40 patients will be recruited in this study. Twenty patients who are diagnosed as inoperable tumor at the time of operation (local invasion to pancrease or great vessels) we will insert a peritoneal dialysis catheter near the tumor to perform percutaneous intraperitoneal chemotherapy. Ten days after the initial operation, we will perform percutaneous intraperitoneal chemotherapy including: mitomycin , cis platin and 5FU for three following days by infusion pump. We will repeat this sequence after 10 days for 3 times. Ten days after latest chemotherapy we will perform laparotomy for possible definitive procedure. Two-year survival rate will be compared between intervention and control groups.
General information
Acronym
no
IRCT registration information
IRCT registration number:IRCT201107257112N1
Registration date:2011-10-03, 1390/07/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-10-03, 1390/07/11
Registrant information
Name
Ramin Azhough
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 1317
Email address
azhoughr@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Liver and Gastrointestinal Diseases Research Center in Tabriz
Expected recruitment start date
2011-09-16, 1390/06/25
Expected recruitment end date
2013-09-21, 1392/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The role of intra-abdominal chemotherapy in inoperable gastric cancer to change to operable tumor in case-control study about one year survival and improve quality of life
Public title
The role of intra-abdominal chemotherapy in inoperable gastric cancer to change to operable tumor
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: presence of criteria for diagnosis as inoperable patient including: 1-local invasion to retroperitoneal organs including: Great veins like aorta-celiac body and solid organs like pancraces. 2 - peritoneal or omentum seeding or metastatic tumor like krukenberg tumor
Exclusion criteria: presence of ascites or metastasis, old age (more than 65 years old), cachectic patients with albumin less than 3 and edema
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University Of Medical Sciences
Street address
Tabriz University Of Medical Sciences, Golgasht avenue,Tabriz
City
Tabriz
Postal code
5166616471
Approval date
2011-06-12, 1390/03/22
Ethics committee reference number
91306/5
Health conditions studied
1
Description of health condition studied
Gastric cancer
ICD-10 code
C16
ICD-10 code description
Malignant neoplasm of stomach
Primary outcomes
1
Description
One year survival
Timepoint
6 months after the end of trial
Method of measurement
Follow up the patients
2
Description
Quality of life
Timepoint
6 months after the end of trial
Method of measurement
Follow up the patients
Secondary outcomes
1
Description
Tumor perforation
Timepoint
Beginning of trial to 6 months after trial
Method of measurement
Follow the patients and study quality of patient`s life
2
Description
Great vesseles perforation
Timepoint
Beginning of trial to 6 months after trial
Method of measurement
Follow the patients and study quality of patient’s life
3
Description
Vomitting
Timepoint
Beginning of trial to 6 months after trial
Method of measurement
Follow the patients and study quality of patient’s life
4
Description
Nausea
Timepoint
Beginning of trial to 6 months after trial
Method of measurement
Follow the patients and study quality of patient`s life
5
Description
Intra abdominal infection
Timepoint
Beginning of trial to 6 months after trial
Method of measurement
Follow the patients and study quality of patient’s life
Intervention groups
1
Description
Intervention group: a peritoneal dialysis catheter is inserted to around the adherence area and its distal is brought out the skin. 10 days after the operation, mitomycin -cisplatin-5 Fluorouacil will be injected from the catheter during for three consecutive days using infusion pump and then the patients will be discharged. 10 days later the laparotomy will be done to explore feasibility of removing tumor.
Category
Treatment - Other
2
Description
Control group: The abdomen will be closed without any intervention or receiving peritoneal chemotherapy.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam reza hospital,Tabriz
Full name of responsible person
Dr. Ramin Azhough, Professor Of General Surgery
Street address
General surgery ward ,Emam reza hospital, Golghasht avenue ,Azadi avenue,Azadi avenue, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Liver and Gastrointestinal Diseases Research Center