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Ethics committees
#1
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2023-12-12, 1402/09/21
2023-12-12 00:00:00
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IR.MEDSAB.REC.1402.089
IR.MEDSAB.REC.1402.089
Recruitment centers
#1
Name of recruitment center - English: Vasei Educational and Medical Center
Name of recruitment center - Persian: مرکز آموزشی درمانی واسعی
Full name of responsible person - English: Seyed Alireza Javadinia
Full name of responsible person - Persian: سید علیرضا جوادی نیا
Street address - English: Vasei hospital , Shohadaye Hasteii Blvd
Street address - Persian: بیمارستان واسعی، بلوار شهدای هسته ای
City - English: Sabzevar
City - Persian: سبزوار
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9617747431
Phone: +98 51 4401 4000
Fax:
Email: javadinia.alireza@gmail.com
Web page address: https://medsab.ac.ir/index.aspx?pageid=339&p=1
Name of recruitment center - English: Vasei Educational and Medical Center Name of recruitment center - Persian: مرکز آموزشی درمانی واسعی Full name of responsible person - English: Seyed Alireza Javadinia Full name of responsible person - Persian: سید علیرضا جوادی نیا Street address - English: Vasei hospital , Shohadaye Hasteii Blvd Street address - Persian: بیمارستان واسعی، بلوار شهدای هسته ای City - English: Sabzevar City - Persian: سبزوار Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9617747431 Phone: +98 51 4401 4000 Fax: Email: javadinia.alireza@gmail.com Web page address: https://medsab.ac.ir/index.aspx?pageid=339&p=1
Sponsors / Funding sources
#1
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50
10050
#2
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Kazem Hasanpour
Full name of responsible person - Persian: کاظم حسن پور
Street address - English: Tohid Shahr BLV.
Street address - Persian: بلوار شهدای هسته ای
City - English: Sabzevar
City - Persian: سبزوار
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9613873136
Phone: +98 51 4401 8319
Fax:
Email: drhassanpour@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Kazem Hasanpour Full name of responsible person - Persian: کاظم حسن پور Street address - English: Tohid Shahr BLV. Street address - Persian: بلوار شهدای هسته ای City - English: Sabzevar City - Persian: سبزوار Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9613873136 Phone: +98 51 4401 8319 Fax: Email: drhassanpour@yahoo.com Web page address:
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۴۰۲۰۴۹
۴۰۲۰۴۹
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Yes
1
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50
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Public
public
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Domestic
domestic
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Academic
academic
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A clinical Trial on the frequency of pathologic complete response in total neoadjuvant treatment in comparison with standard approach in patients with rectal adenocarcinoma
A clinical Trial on the frequency of pathologic complete response in total neoadjuvant treatment in comparison with standard approach in patients with rectal adenocarcinoma
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یک کارآزمایی بالینی در خصوص بررسی فراوانی پاسخ کامل پاتولوژی در بیماران مبتلا به آدنوکارسینوم رکتوم تحت درمان نئوادجوانت کامل در مقایسه با درمان استاندارد
یک کارآزمایی بالینی در خصوص بررسی فراوانی پاسخ کامل پاتولوژی در بیماران مبتلا به آدنوکارسینوم رکتوم تحت درمان نئوادجوانت کامل در مقایسه با درمان استاندارد
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Sabzevar University of Medical Sciences
Sabzevar University of Medical Sciences
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دانشگاه علوم پزشکی سبزوار
دانشگاه علوم پزشکی سبزوار
Protocol summary
Study aim
To compare the effectiveness of the total neoadjuvant therapy with standard approach in rectal adenocarcinoma patients
Design
This randomized and single-blind clinical trial with parallel and control groups will be conducted on 60 patients who will be randomly selected using the blocks.
Settings and conduct
Patients with rectal adenocarcinoma referring to Omid and Imam Reza Hospital, Mashhad, Iran are chosen as the participants of the study. In this single-blind study, sealed opaque envelopes will be used to conceal the sequencing. The person responsible for data collection is blind to group allocation and the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with rectal adenocarcinoma based on pathological diagnosis; the zero to two level of Eastern Cooperative Oncology Group (ECOG); healthy functioning bone marrow; healthy functioning liver; healthy functioning kidneys.
Exclusion criteria: Having simultaneous adenocarcinoma in other areas of the colon; having metastasis; history of previous malignancy; history of chemotherapy; history of pelvic radiotherapy; having inflammatory intestinal disease; having bilateral hip prosthesis; having allergic to 5-fluorouracil and its other derivatives; having allergic to oxaliplatin.
Intervention groups
In the intervention group, the patient will receive neoadjuvant treatment with pelvic radiotherapy along with capecitabine capsule, then neoadjuvant chemotherapy with FOLFOX or CapOx regimen, and finally definitive surgery.
In the control group, the patient will undergo standard treatment in the form of first neoadjuvant treatment by pelvic radiotherapy with capecitabine capsules, then definitive surgery and finally adjuvant chemotherapy with FOLFOX or CapOx regimen.
Main outcome variables
Evaluation and comparison of the pathological complete response, local recurrence and distant metastasis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220723055527N1
Registration date:2022-11-07, 1401/08/16
Registration timing:prospective
Last update:2024-01-02, 1402/10/12
Update count:1
Registration date
2022-11-07, 1401/08/16
Registrant information
Name
Fereshteh Foroughi Pordanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3833 0626
Email address
foroughifrshte@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-11, 1401/09/20
Expected recruitment end date
2023-09-22, 1402/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effectiveness of the total neoadjuvant therapy with standard approach in rectal adenocarcinoma patients
Public title
The effectiveness of the total neoadjuvant therapy in in rectal adenocarcinoma patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with rectal adenocarcinoma based on pathological diagnosis
The zero to two level of Eastern Cooperative Oncology Group (ECOG)
Healthy functioning bone marrow
Healthy functioning liver
Healthy functioning kidneys
Exclusion criteria:
Having simultaneous adenocarcinoma in other areas of the colon
Having metastasis
History of previous malignancy
History of chemotherapy
History of pelvic radiotherapy
Having inflammatory intestinal disease
Having bilateral hip prosthesis
Having allergic to 5-fluorouracil and its other derivatives
Having allergic to oxaliplatin
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the restricted randomization method of block randomization base on statistical analysis system (SAS), computer software. All blocks are the same size, and in this two-group experiment we will have 6 blocks (including 3 participants in the intervention group and 3 participants in the control group). Random allocation software software is also used to randomize random sequence production software (Random allocation software). To conceal, we use Allocation concealment, which refers to the method used to perform a random sequence on study participants, so that the assigned group is not identified before the individual is assigned. Using non-transparent envelopes sealed with random sequences (Sequentially numbered, sealed, opaque envelopes). They are placed in order. In order to maintain the random sequence, numbering is done on the outer surface of the envelopes in the same way. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants in the study, one of the envelopes of the letter will be opened in order and the assigned group of the participant will be revealed.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyzer does not know which groups are located. The statistician will receive questionnaires as anonymously and in form A and B, and he/she does not know which are received the total neoadjuvant therapy or standard approach.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
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Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Approval date
2022-04-19, 1401/01/30
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1401.053
2
Ethics committee
Name of ethics committee
Research Ethics Committees of Sabzevar University of Medical Sciences
Street address
Nuclear Martyrs Boulevard, above the Memorial of the Unknown Martyrs, Campus of the University of Medical Sciences, Vice Chancellor for Research and Technology
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Approval date
2023-12-12, 1402/09/21
Ethics committee reference number
IR.MEDSAB.REC.1402.089
Health conditions studied
1
Description of health condition studied
Rectal adenocarcinoma
ICD-10 code
C20
ICD-10 code description
Malignant neoplasm of rectum
Primary outcomes
1
Description
The pathological complete response
Timepoint
One week after surgery
Method of measurement
Based on surgical pathology report
2
Description
Local recurrence
Timepoint
One year after intervention
Method of measurement
Pelvic computed tomography (CT) scan and colonoscopy
3
Description
Distant metastasis
Timepoint
One year after intervention
Method of measurement
Abdominal and pelvic CT scan
Secondary outcomes
1
Description
Complications of treatment
Timepoint
One, two and three weeks after treatment
Method of measurement
Based on the Common Terminology Criteria for Adverse Events (CTCAE)
Intervention groups
1
Description
Intervention group: The intervention group will first receive neoadjuvant treatment via pelvic radiotherapy with capecitabine tablets, then neoadjuvant chemotherapy with FOLFOX or CapOx regimen, and finally definitive surgery.
Category
Treatment - Drugs
2
Description
Control group: The control group will receive standard treatment in the form of neoadjuvant treatment via pelvic radiotherapy with capecitabine tablets, then definitive surgery and finally adjuvant chemotherapy with FOLFOX or CapOx regimen.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid hospital
Full name of responsible person
Fereshteh Foroughi Pordanjani
Street address
Omid Hospital, Al-Nandasht Square, Kooh Sangi Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3833 0626
Email
foroughifreshte@gmail.com
2
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Fereshteh Foroughi Pordanjani
Street address
Imam Reza Hospital, Imam Reza Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 1761 5063
Email
foroughifrshte@gmail.com
3
Recruitment center
Name of recruitment center
Vasei Educational and Medical Center
Full name of responsible person
Seyed Alireza Javadinia
Street address
Vasei hospital , Shohadaye Hasteii Blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617747431
Phone
+98 51 4401 4000
Email
javadinia.alireza@gmail.com
Web page address
https://medsab.ac.ir/index.aspx?pageid=339&p=1
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
50
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
2
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Kazem Hasanpour
Street address
Tohid Shahr BLV.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 8319
Email
drhassanpour@yahoo.com
Grant name
A clinical Trial on the frequency of pathologic complete response in total neoadjuvant treatment in comparison with standard approach in patients with rectal adenocarcinoma
Grant code / Reference number
۴۰۲۰۴۹
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar University of Medical Sciences
Proportion provided by this source
50
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
Mashhad University of Medical Sciences
Full name of responsible person
Fereshteh Foroughi Pordanjani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiology
Street address
Omid Hospital, Al-Nandasht Square, Kooh Sangi Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3833 0626
Email
foroughifrshte@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fereshteh Foroughi Pordanjani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiology
Street address
Omid Hospital, Al-Nandasht Square, Kooh Sangi Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3833 0626
Email
foroughifrshte@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fereshteh Foroughi Pordanjani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiology
Street address
Omid Hospital, Al-Nandasht Square, Kooh Sangi Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3833 0626
Email
foroughifrshte@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
In our study none of the personal data of patients will be shared. Only data that are related to outcomes of intervention will be shared.
When the data will become available and for how long
6 months after publishing the results
To whom data/document is available
The research data is exclusively accessible to the researchers working at universities and centers for scientific research.
Under which criteria data/document could be used
The research data is exclusively accessible to the researchers working at universities and centers for scientific research.
From where data/document is obtainable
Fereshteh Foroughi Pordanjani provides the data analysis to the applicants via email: foroughifrshte@gmail.com
What processes are involved for a request to access data/document
Applicants can send emails to him and receive a response within a week.