Check the benefits of preoperative chemotherapy in the treatment of patients with gastric cancer; Effects of preoperative chemotherapy regimens in selected patients; Surgical complications in patients receiving neoadjuvant chemotherapy; Clinical response (stage clinical) to chemotherapy prior to surgery; Pathological response (stage pathological) to chemotherapy prior to surgery; The response to neoadjuvant chemotherapy according to age and sex. Neoadjuvant chemotherapy is given in 3 preoperational periods. Choice regime was Ajani (taxotere 80 mg/m2, Cisplatin 70 mg/m2, 5-FU 750 mg/m2). After chemotherapy, the patient's CT scan was performed again and patients who have had a partial response or stable condition, surgery were performed. After surgery, the samples were sent for pathologic assessment. Patients received 3 courses of chemotherapy just as the same regimen before surgery. Inclusion criteria: diagnosis of gastric cancer; stage 2 and 3 gastric cancer; surgical patient; age 18-75 years old. Exclusion criteria: the patient's unwillingness to participate in the study; age over 75 years old; the underlying conditions; gastric cancer in stages 1 and 4; the recent history of chemotherapy or radiotherapy; performance state less than 70 Karnofsky score.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015020220906N1
Registration date:2015-02-15, 1393/11/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-15, 1393/11/26
Registrant information
Name
Ali Hossein Samadi Takaldani
Name of organization / entity
Ardabil University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 45 3381 1142
Email address
ah.samadi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardabil University of Medical Sciences
Expected recruitment start date
2015-01-20, 1393/10/30
Expected recruitment end date
2015-06-21, 1394/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of neoadjuvant chemotherapy in patients with gastric cancer referred to the oncology clinic of Imam Khomeini Hospital of Ardabil
Public title
Effect of neoadjuvant chemotherapy in patients with gastric cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of gastric cancer; stage 2 and 3 gastric cancer; surgical patient; age 18-75 years old.
Exclusion criteria: the patient's unwillingness to participate in the study; age over 75 years old; the underlying conditions; gastric cancer in stages 1 and 4; the recent history of chemotherapy or radiotherapy; performance state less than 70 Karnofsky score.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ardabil University of Medical Sciences
Street address
Ardabil University of Medical Sciences, Daneshgah street, Near Shurabil Lake
City
Ardabil
Postal code
Approval date
2013-07-14, 1392/04/23
Ethics committee reference number
Arums.REC.92.14
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
TNM staging
Timepoint
Before and after chemotherapy
Method of measurement
TNM staging and questionnaire
Secondary outcomes
1
Description
Neoadjuvant chemotherapy side effects
Timepoint
Before surgery
Method of measurement
Questionnaire
Intervention groups
1
Description
The regime Ajani (Taxoter 80mg / m2 - cisplatin 70mg / m2 and 5FU 750mg / M2) are used before and after chemotherapy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ardabil Emam Khomeini hospital
Full name of responsible person
Ali Hossein Samadi- internal medicine, resident
Street address
Ardabil Emam Khomeini hospital, Gafur Jeddi street
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research and Technology
Full name of responsible person
Shahram Habibzadeh
Street address
Emam Khomeini Hospital
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?