Comparison of efficacy and adverse effects of two chemotherapy regimens including carboplatin-paclitaxel and capecitabine-oxaliplatin in neo-adjuvant chemo-radiation of esophageal cancer for patients who were referred to Imam Khomeini cancer institute during year 95-96
Comparison of efficacy and adverse effects of two chemotherapy regimens including carboplatin-paclitaxel and capecitabine-oxaliplatin in neo-adjuvant chemo-radiation of esophageal cancer for patients who were referred to Imam Khomeini cancer institute during year 95-96
Design
Two arm parallel group randomised trial without blindness to assess the efficacy and adverse effects of chemotherapy regimens.
Settings and conduct
Trial will be conducted in Imam Khomeini cancer institute. Esophageal cancer patients who are candidate for neo-adjuvant chemo-radiation will be entered. This trail will be done without blinding.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Patients who are between 18-75 years old
2.Tumor should located in thoracic esophagus or gastro-esophageal junction. 3. Pathology consists of squamous cell carcinoma or adenocarcinoma.
4. Tumor should be resectable.
5. Disease should be curable
Exclusion criteria:
1. Patient who suffers from bad performance status.
Intervention groups
Esophageal cancer patients will receive one of chemotherapy regimens as neo-adjuvant chemo-radiation. Intervention group will receive carboplatin-paclitaxel. Control group will get chemotherapy consist of capecibatine-oxaliplatin.
Main outcome variables
Tumor regression grade
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140903019036N3
Registration date:2018-08-17, 1397/05/26
Registration timing:registered_while_recruiting
Last update:2018-08-17, 1397/05/26
Update count:0
Registration date
2018-08-17, 1397/05/26
Registrant information
Name
Borna Farazmand
Name of organization / entity
Tehran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8842 9230
Email address
borna1367@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy and adverse effects of two chemotherapy regimens including carboplatin-paclitaxel and capecitabine-oxaliplatin in neo-adjuvant chemo-radiation of esophageal cancer for patients who were referred to Imam Khomeini cancer institute during year 95-96
Public title
Comparison of two chemotherapy regimens including carboplatin-paclitaxel and capecitabine-oxaliplatin in neo-adjuvant chemo-radiation of esophageal cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Tumor should located in thoracic esophagus or gastro-esophageal junction.
Patients' age should be between 18-75 years old.
Pathology consists of squamous cell carcinoma or adenocarcinoma.
Tumor should be resectable.
Disease should be curable.
Exclusion criteria:
Patient who suffers from bad performance status.
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
Before starting the study, 4 part blocks consisting A and B were generated randomly. Patients were assigned to blocks consecutively. Codes were belonged to two groups consist of carboplatin-paclitaxel or capecitabine-oxaliplatin and so patients were randomized to two groups.
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
Ethics committee of ّImam Khomeini Hospital
Street address
East Baqerkhan St, Chamran Highway, Tehran, Tehran Province
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Approval date
2017-09-04, 1396/06/13
Ethics committee reference number
IR.TUMS.IKHC.REC.1396.3365
Health conditions studied
1
Description of health condition studied
Esophageal cancer
ICD-10 code
C15.5
ICD-10 code description
Malignant neoplasm of lower third of esophagus
Primary outcomes
1
Description
Tumor regression grade
Timepoint
Tumor regression grade will determine once after surgery.
Method of measurement
Tumor regression grade will determine through surgical sample by pathologist.
Secondary outcomes
1
Description
Gastrointestinal adverse effects
Timepoint
Gastrointestinal adverse effects will be evaluated at 1 and 3 months after neo-adjuvant chemoradiation.
Method of measurement
Gastrointestinal adverse effects will be evaluated through CTCAE (Common Terminology Criteria for Adverse Events).
2
Description
Hematologic adverse effects
Timepoint
Hematologic adverse effects will be evaluated at 1 and 3 months after neo-adjuvant chemoradiation.
Method of measurement
Hematologic adverse effects will be evaluated through CTCAE (Common Terminology Criteria for Adverse Events).
3
Description
Surgical margin's tumor remnant
Timepoint
Surgical margin's tumor remnant is determined once after surgery.
Method of measurement
Surgical margin's tumor remnant is determined through pathologist's assessment.
Intervention groups
1
Description
Intervention group: chemotherapy with oxaliplatin (85 mg/m2, week 1, 3, 5) + capecitabine (625mg/m2, BD, day 1 to 5, weekly), during radiotherapy
Category
Treatment - Drugs
2
Description
Control group: chemotherapy with carboplatin (AUC = 2) + Paclitaxel (50 mg/m2), weekly, during radiotherapy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran cancer institute
Full name of responsible person
Borna Farazmand
Street address
East Baqerkhan St, Chamran Highway, Tehran, Tehran Province
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119
Email
b-farazmand@razi.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Ebrahim Esmati
Street address
East Baqerkhan St, Chamran Highway, Tehran, Tehran Province
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119
Fax
Email
eb_esmati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
40
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Borna Farazmand
Position
Resident of clinical oncology
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
East Baqerkhan St, Chamran Highway, Tehran, Tehran Province
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 2518
Email
b-farazmand@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ebrahim Esmati
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
East Baqerkhan St, Chamran Highway, Tehran, Tehran Province
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119
Email
eb_esmati@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Borna Farazmand
Position
Resident of clinical oncology
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
East Baqerkhan St, Chamran Highway, Tehran, Tehran Province
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119
Email
b-farazmand@razi.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Data of other research maybe becomes at risk
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The report of study will be released
When the data will become available and for how long
It will be after publishing the paper.
To whom data/document is available
The results will be accessible for all
Under which criteria data/document could be used
To administer in clinical decision making the result will be accessible.
From where data/document is obtainable
To receive the results contact to correspondent.
What processes are involved for a request to access data/document