Sixty patients with gastric adenocarcinoma who have locally-advanced disease will be studied during this trial. The diagnosis of gastric adenocarcinoma will be made by endoscopic biopsy and subsequent histopathological analysis. A computed tomography (CT) scan of abdomen and pelvis will be conducted for the study subjects. Presence of perigastric lymph node involvement in tumors of T2 and T3 size will be considered locally-advanced. The patients will be divided into two groups randomly. The first group will receive preoperative chemotherapy based on docetaxel, cisplatin and 5-FU regimen (Case group). This regimen will be used for 6 courses. The comtrol group will not receive any neoadjuvant chemotherapy. A repeat abdominopelvic CT scan will be conducted for the patients of the case group to document the probable lymph node regression. All patient will undergo surgical exploration for assessment of resectability. In the case group, the operation will be conducted 6-weeks after the last chemotherapy session. The resectability of locally-advanced gastric adenocarcinoma will be compared between two groups. The analysis will be conducted by Chi-square test using SPSS 19.0 software. The frequency of lymph node shrinkage in repeat CTs of patients who received neoadjuvant chemotherapy will be described. Demographic variables and in-hospital findings were also be recorded for all patients and will be compared between case and control groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014053113736N1
Registration date:2014-06-02, 1393/03/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-02, 1393/03/12
Registrant information
Name
Sina Zarrintan
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1330 1116
Email address
zarrintans@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy,
Faculty of Medicine,
Tabriz University of Medical Sciences
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2014-04-20, 1393/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of neoadjuvant chemotherapy on increasing resectability in patients with locally-advanced gastric cancer
Public title
Neoadjuvant chemotherapy in gastric adenocarcinoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1) Age between 18-70 years old
2) Confirmation of gastric adenocarcinoma by endoscopic sampling and histopathological analysis
3) Confirmation of locally-advanced disease by preoperative computed tomography
4) Confirmation of resectability by preoperative computed tomography
Exclusion criteria:
1) Ages older than 70
2) Gastric malignancies other than adenocarcinoma
3) Distant metastasis in preoperative assessment
4) Any contraindication to chemotherapy
5) History of previous chemotherapy
6) History of previous radiotherapy
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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
Golgasht St. Tabriz University
City
Tabriz
Postal code
Approval date
2012-06-19, 1391/03/30
Ethics committee reference number
524-9336
Health conditions studied
1
Description of health condition studied
Gastric adenocarcinoma
ICD-10 code
C16
ICD-10 code description
Malignant neoplasm of stomach
Primary outcomes
1
Description
Reseactability
Timepoint
Intraoperative (After chemotherapy in case group and after diagnosis in control group)
Method of measurement
Intraoperative findings
Secondary outcomes
1
Description
Local lymph node regression
Timepoint
After neoadjuvant chemotherapy (6 weeks)
Method of measurement
Computed tomography
Intervention groups
1
Description
Control group:
Surgical exploration without neoadjuvant chemotherapy
Category
Treatment - Surgery
2
Description
Intervention Group
Neoadjuvant chemotherapy:
- docetaxel 75 mg/m2, IV, 1 hour infusion, day 1
- cisplatin 75 mg/m2, IV , 2hour infusion, day 1
- 5 FU 750 mg/m2/day, IV continuous infusion, days 1-5
Will be repeat every 3 weeks for 6 courses
Surgical exploration 6 weeks after the last course of chemotherapy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Shahriyar Hashemzadeh
Street address
Imam Reza Hospital, Golgasht St.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Jafar Soleimanpour
Street address
Imam Reza Hospital, Golgasht St.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Shahriyar Hashemzadeh
Position
Professor of General and Thoracic Surgery/ MD
Other areas of specialty/work
Street address
Imam Reza Hospital, Golgasht St.
City
Tabriz
Postal code
51664
Phone
+98 41 1334 1317
Fax
+98 41 1334 1317
Email
shahriar_90@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Shahriyar Hashemzadeh
Position
Professor of General and Thoracic Surgery/ MD
Other areas of specialty/work
Street address
Imam Reza Hospital, Golgasht St.
City
Tabriz
Postal code
51664
Phone
+98 41 1334 1317
Fax
+98 41 1334 1317
Email
shahriar_90@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Sina Zarrintan
Position
Resident of General Surgery
Other areas of specialty/work
Street address
Imam Reza Hospital, Golgasht St.
City
Tabriz
Postal code
Phone
+98 41 1330 1116
Fax
+98 41 1333 4244
Email
s.zarrintan@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)