Determination of the Effect of Metfomin on Pathologic Complete Response (pCR) to Chemoradiotherapy of Rectal Cancer in Non-diabetic Patients
Design
Two arm parallel group & single blinded randomized trial
Settings and conduct
This study will be conducted on patients with rectal cancer referred to radiation oncology department of Namazi hospital in Shiraz during September 2017 and April 2019. All patients will be done 2 cycles of chemotherapy (with XELOX regimen), long course RT (50.4 Gy in 1.8 - 2 Gy per fraction) followed by surgery. The case group will be taken metformin 500 mg Po Bid after eating and taking into account the contraindications (N = 45), and the control group will not be taken metformin (N = 45). The patient will be unaware of medication content (single blinded). Adverse effects of intervention will be evaluated. A standard surgical planning will be considered for all patients. Postsurgical pathology examination provides a description of the specimen.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients aged 18 to 75 y/o with performance status <2 with rectal adenocarcinoma; non-diabetics treated from 2017 to 2019 with neoadjuvant chemoradiation followed by surgical resection at a single institution.
Exclusion criteria: All patients treated with surgery or radiation alone; those with distant metastatic disease at the time of presentation; having another malignancy; a Hx of previous RT to pelvis; any contraindication for RT; and a Hx of hypersensitivity reaction to the medications.
Intervention groups
1- case group: taking metformin 500 mg Po Bid after eating and taking into account the contraindications (N = 45); 2- control group: not taking metformin (N = 45).
Main outcome variables
The primary outcome is pathologic complete response, and the secondary outcome includes side effects.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190726044335N1
Registration date:2019-08-20, 1398/05/29
Registration timing:prospective
Last update:2019-08-20, 1398/05/29
Update count:0
Registration date
2019-08-20, 1398/05/29
Registrant information
Name
Monireh Jelodari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4320
Email address
mjelodari@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Evaluation of the Effect of Metformin on Pathologic Complete Response (pCR) to Chemoradiotherapy of Rectal Cancer in Non-Diabetic Patients
Public title
Therapeutic effect of metformin in rectal cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All non-diabetic patients with rectal adenocarcinoma aged 18 to 75 y/o and performance status <2
Exclusion criteria:
Treatment with surgery or radiation alone, distant metastasis, previous pelvic radiotherapy, and hypersensitivity reaction to the medications
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Using the random numbers table
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient will not be unaware of the medication content
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Faculty of medicine, Zand Avenue
City
Shiraz
Province
Fars
Postal code
71937-11351
Approval date
2019-04-28, 1398/02/08
Ethics committee reference number
IR.SUMS.MED.REC.1398.104
Health conditions studied
1
Description of health condition studied
Rectal cancer
ICD-10 code
C20
ICD-10 code description
Malignant neoplasm of rectum
Primary outcomes
1
Description
Pathologic complete response
Timepoint
Post operation
Method of measurement
Pathologic examination
Secondary outcomes
1
Description
Side effects
Timepoint
Weekly during intervention course
Method of measurement
Radiation therapy oncology group toxicity criteria
Intervention groups
1
Description
Intervention group: The patients with rectal cancer in the case group will be taken the metformin 500 mg Po Bid after eating and taking into account the contraindications.
Category
Treatment - Drugs
2
Description
Control group: The patients with rectal cancer in the control group will not be taken the metformin.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Shapour Omidvari
Street address
Thirty-Sixth room, Department of radiation oncology, Namazi hospital, Namazi square
City
Shiraz
Province
Fars
Postal code
71937-11351
Phone
+98 71 3647 4320
Fax
+98 71 3647 4320
Email
omidvari@sums.ac.ir
Web page address
http://www.sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Ghasemi
Street address
Deputy of Research, Shiraz University of Medical Sciences, Zand Avenue
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Web page address
http://research.sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Monireh Jelodari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Forty-second room, Department of radiation oncology, Namazi hospital, Namazi square
City
Shiraz
Province
Fars
Postal code
71937-11351
Phone
+98 71 3647 4320
Fax
+98 71 3647 4320
Email
mjelodari@sums.ac.ir
Web page address
http://www.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shapour Omidvari
Position
Full Professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Thirty-Sixth room, Department of radiation oncology, Namazi hospital, Namazi square
City
Shiraz
Province
Fars
Postal code
71937-11351
Phone
+98 71 3647 4320
Fax
+98 71 3647 4320
Email
omidvari@sums.ac.ir
Web page address
http://www.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Monireh Jelodari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Forty-second room, Department of radiation oncology, Namazi hospital, Namazi square
City
Shiraz
Province
Fars
Postal code
71937-11351
Phone
+98 71 3647 4320
Fax
+98 71 3647 4320
Email
mjelodari@sums.ac.ir
Web page address
http://www.sums.ac.ir
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
Information about main outcomes of the study
When the data will become available and for how long
Six months after publishing the results
To whom data/document is available
Researchers in universities and scientific and research cente
Under which criteria data/document could be used
In order to improve the treatment of the disease and subsequent research and with the permission of the authors
From where data/document is obtainable
Department of radiation oncology of Shiraz university of medical sciences
What processes are involved for a request to access data/document
Sending the request in writing or by email to the authors