The objective of this study is to investigate disease free survival of patients with gastric cancer who are treated with surgery then chemoradiotherapy or vice versa. In this phase III clinical trial, patients with primary gastric cancer are randomly assigned to undergo surgery and then receive chemoradiotherapy or receive chemoradiotherapy and then surgery. After that, the patients in both groups receive chemotherapy for 3-4 times. All patients are visited frequently during the study period and any adverse effects will be recorded. Response to treatment is evaluated by post operative pathology and disease free survival time is measured by systematic follow-ups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138901111155N7
Registration date:2010-09-10, 1389/06/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-09-10, 1389/06/19
Registrant information
Name
Farahnaz Joukar
Name of organization / entity
Guilan University of Medical Sciences, Gastrointestinal and liver disease Research Center
Country
Iran (Islamic Republic of)
Phone
+98 13 1553 5116
Email address
info@gldrc.org
Recruitment status
Recruitment complete
Funding source
Gastrointestinal and Liver Diseases Research Center
Expected recruitment start date
2010-07-06, 1389/04/15
Expected recruitment end date
2013-07-23, 1392/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To compare disease free survival between conventional method and chemotherapy before surgery in patient with gastric cancer.
Public title
To compare disease free survival of patient with gastric cancer between 2 treatment regimens.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Primary gastric cancer in non cardiac area, No distant metastasis, Age less than 70 years old, Normal CBC (Hb>10, Plt>100/000, WBC>4000, PMN>1500), normal liver and kidney function, Satisfaction of patients to do this treatment, Conformance of surgeon for operation, No excessive changes in patients' weight, Carnofski criteria>70
Exclusion criteria: History of other cancers (instead of non melanocytic cancer of skin, History of major medical diseases (Intensive heart and/or lung disease)
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Gastrointestinal and Liver Diseases Research Center
Street address
Gastrointestinal and Liver Diseases Research Center- Razi hospital - Sardar Jangal Ave-Rasht-Iran
City
Rasht
Postal code
4144895655
Approval date
2009-11-11, 1388/08/20
Ethics committee reference number
148
Health conditions studied
1
Description of health condition studied
Gastric cancer
ICD-10 code
C16.9
ICD-10 code description
Malignant neoplasm of stomach, Stomach, unspecified Stomach
Primary outcomes
1
Description
Response to neoadjuvant therapy
Timepoint
After surgery; every month until 3 months, every 3 months until 6 months and every 6 months until 36 months.
Method of measurement
pathological report
2
Description
Disease free time
Timepoint
Every month until 3 months, every 3 months until 6 month, every 6 month until the end of follow up
Method of measurement
In years, pathologic results during the follow-ups
Secondary outcomes
1
Description
Side effects of the treetment
Timepoint
Every month until 3 months, every 3 months until 6 months, every 6 months until the end of follow up
Method of measurement
Interview and physical exam
Intervention groups
1
Description
In neo-adjuvant group (Cases); patients receive chemotherapy (Cisplatin 20mg/m2 and 5FU 325mg/m2) and simultaneous abdomen and stomach Cobalt radiotherapy before radical surgery of the stomach. Finally, they receive ECX regimen; Xeloda (Capecitabin 625 mg) twice a day and Epirubicin 50 mg/m2 for 2 weeks.
Category
Treatment - Drugs
2
Description
In adjuvant group (Controls); patients undergo radical surgery then receive chemotherapy (Leukotrien 30mg/m2 for 4 days and 5FU 325mg/m2) and abdomen and stomach Cobalt radiotherapy in the first and last weeks, and after that receive 3-4 periods of ECX. ECX regimen contains; Xeloda (Capecitabin 625 mg) twice a day and Epirubicin 50 mg/m2 for 2 weeks.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastrointestinal and Liver Diseases Research Center
Full name of responsible person
Professor Fariborz Mansour-Ghanaei
Street address
Gastrointestinal and Liver Diseases Research Center- Razi Hospital - Sardar Jangal Ave
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gastrointestinal and Liver Diseases Research Center
Full name of responsible person
Farahnaz Joukar
Street address
Gastrointestinal and Liver Diseases Research Center- Razi hospital - Sardar Jangal Ave
City
Rasht
Grant name
Grant code / Reference number
152
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gastrointestinal and Liver Diseases Research Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Gastrointestinal and Liver Diseases Research Center
Full name of responsible person
Farahnaz Joukar
Position
Assistant of Gastrointestinal and Liver Diseases Research Center
Other areas of specialty/work
Street address
Gastrointestinal and Liver Diseases Research Center- Razi hospital - Sardar Jangal Ave
City
Rasht
Postal code
Phone
00981315535116-00989113811118
Fax
Email
F_Jokar@gums.ac.ir www.gldrc.org
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gastrointestinal and Liver Diseases Research Center
Full name of responsible person
Dr. Fariborz Mansour-Ghanaei
Position
Professor of Internal Medicine & gastroenterology
Other areas of specialty/work
Street address
Gastrointestinal and Liver Diseases Research Center- Razi Hospital - Sardar Jangal Ave
City
Rasht
Postal code
Phone
00981315535116- 00989111313787
Fax
Email
Ghanaei@gums.ac.ir www.gldrc.org
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Gastrointestinal and Liver Diseases Research Center
Full name of responsible person
Dr Mahsa Rostami
Position
Doctor
Other areas of specialty/work
Street address
Gastrointestinal and Liver Diseases Research Center- Razi Hospital - Sardar Jangal Ave
City
Rasht
Postal code
Phone
+98 13 1553 5116
Fax
Email
mahsa_59_2007@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)