Comparison of response and toxicity of capecitabine and oxaliplatin chemotherapy regimen with taxol and carboplatin with radiotherapy in esophageal cancer patients
Comparison of response and toxicity of two different regimens of chemotherapy with esophageal cancer
Design
The study is a clinical trial in which two groups of 35 patients are evaluated in parallel with two different chemotherapy regimens with radiotherapy and the patients rate of response (rate of pathologic response through surgery or re-endoscopy) as well as complications are compared. The study is a single-blind study and patients in each group are unaware of the treatment and outcome of the opposite group.
Settings and conduct
Patients were recruited in two groups of 35 patients with esophageal cancers diagnosed at Firoozgar Hospital and Haft Tir Hospital from 1396 to 1398. Patients in each group will receive a special chemotherapy regimen with radiotherapy and upon completion chemoradiotherapy, A group of patients who are candidates for surgery will undergo surgery, and a group of patients who are not candidates for surgery will undergo re-endoscopy (it is important to be diagnosed with EUS at the beginning of the disease diagnosis), and then patients will be compared in both groups for treatment response and complications with different chemotherapy regimens
Participants/Inclusion and exclusion criteria
Under 80 years of age. Do not have severe dysphagia. No cervical esophageal involvement.
Intervention groups
Two groups of 35 esophageal cancer patients receiving different chemotherapy regimens with radiotherapy will be compared.
One group will receive taxol and carboplatin regimens with radiotherapy and one group will receive capecitabine and oxaliplatin with radiotherapy and will then compare the pathologic and clinical response rates and complications between the two groups.
Main outcome variables
Pathologic response rate. Clinical response rate. Complications include: diarrhea and fatigue. Anorexia rate. Neutropenia and thrombocytopenia. Esophagitis severity.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170306032913N4
Registration date:2020-02-16, 1398/11/27
Registration timing:registered_while_recruiting
Last update:2020-02-16, 1398/11/27
Update count:0
Registration date
2020-02-16, 1398/11/27
Registrant information
Name
Alireza Nikoofar
Name of organization / entity
Firoozgar Clinical Research Development Center (FCRDC)
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1743
Email address
nikoofar@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of response and toxicity of capecitabine and oxaliplatin chemotherapy regimen with taxol and carboplatin with radiotherapy in esophageal cancer patients
Public title
Comparison of response and toxicity of capecitabine and oxaliplatin chemotherapy regimen with taxol and carboplatin with radiotherapy in esophageal cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Proper Performance Status.
No severe dysphagia
Exclusion criteria:
Age over 80.
Cervical Esophageal involvement
Age
From 40 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are divided into two groups with two different chemotherapy regimens that are prescribed in combination with radiotherapy. The disadvantages are described in each group but patients in each group will not be aware of the other group's line therapy. It also analyzes data without any benefit or potential loss
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Department of Radiotherapy,Firoozgar Hospital,Valadi Ave,Valiasr Square,Tehran
City
Tehran
Province
Tehran
Postal code
1593748711
Approval date
2019-09-28, 1398/07/06
Ethics committee reference number
IR.IUMS.FMD.REC.1398.220
Health conditions studied
1
Description of health condition studied
Chemoradiotherapy in esophageal cancer patients
ICD-10 code
C15
ICD-10 code description
Malignant neoplasm of esophagus
Primary outcomes
1
Description
Pathologic and clinical response to chemoradiotherapy with two different regimens in esophageal cancer patients
Timepoint
Evaluation of response rate after completion of chemoradiotherapy and evaluation and comparison of complications during treatment
Method of measurement
Postoperative pathology report. EUS re-report after chemoradiotherapy
Secondary outcomes
empty
Intervention groups
1
Description
Control group of 35 esophageal cancer patients receiving weekly paclitaxel (75mg/m2) and carboplatin (AUC:2)regimen with 5 days a week radiotherapy ( total dose:45-50Gy)
Category
Treatment - Drugs
2
Description
The intervention group of 35 esophageal cancer patients receiving capcitabine( 625mg/m2 daily during radiotherapy) and weekly oxaliplatin (50 mg/m2) regimen with 5 days a week radiotherapy ( total dose:45-50Gy)
Department of Radiotherapy,Firouzgar Hospital,Valadi St,Valiasr Square,Tehran
City
Tehran
Province
Tehran
Postal code
1593748711
Phone
+98 21 8214 1792
Email
arnikoofar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
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
Iran University of Medical Sciences
Full name of responsible person
Alireza Nikoofar
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Department of Radiotherapy,Firooz Hospital,Valadi St,Valiasr Square,Tehran
City
Tehran
Province
Tehran
Postal code
1593748711
Phone
+98 21 8214 1792
Fax
+98 21 8214 1782
Email
arnikoofar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Alireza Nikoofar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Department of Radiotherapy,Firouzgar Hospital,Valadi St,Valiasr Square,Tehran
City
Tehran
Province
Tehran
Postal code
1593748711
Phone
+98 21 8214 1792
Email
arnikoofar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Aida Cheraghi
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Department of Radiotherapy,Firouzgar Hospital,Valadi St,Valiasr Square,Tehran
City
Tehran
Province
Tehran
Postal code
1593748711
Phone
+98 21 8214 1792
Email
aidacheraghi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All patient documentation, including participants' personal information, will be shared after unidentifiable individuals, and the main outcome will include the extent of pathologic and clinical response and the extent of any of the listed complications will be shared
When the data will become available and for how long
Access started in 1399
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
The information will be made available to researchers who want to continue to plan or compare results with other regimens.
From where data/document is obtainable
Department of Radiotherapy, Firoozgar Hospital, Dr. Ali Reza Nikofar
arnikoofar@gmail.com
What processes are involved for a request to access data/document
Visit to the Radiotherapy Department of Firoozgar Hospital and Dr. Nikoofar
The applicant was provided with information for about a week