Evaluating the rate of complete clinical response following total neoadjuvant therapy by using chemoradiotherapy by Intensity modulated radiation therapy with simultaneous integrated boost (IMRT-SIB) in patients with lower rectal cancer; a Phase II randomized clinical trial
Investigation of complete clinical response in patients with lower rectal cancer treated with integrated chemoradiotherapy and boost technique
Design
This study is a single-arm phase 2 clinical trial, based on the 1-Sample 2-Sided Equality formula, about 29 patients are needed.
Settings and conduct
Data collection in this study will be through information registration forms specific to this project and follow-up in the form of telephone interviews and examination of the results recorded in the patients' files by colonoscopy, MRI and pathology modalities. The study period will be from 1402 to 1404 on patients referred to the Cancer Institute of Imam Khomeini Hospital
Participants/Inclusion and exclusion criteria
Entry requirements: age over 18 years with lower rectal cancer within 5 cm of the anal wedge and non-metastaticConditions of non-entry: history of malignancy or digestive problems, inability to perform MRI, presence of active cancer in another part of the body
Intervention groups
Patients will undergo radiotherapy and chemotherapy simultaneously with capecitabine tablets five days a week. After radiotherapy, T3/4 or N+ patients undergo chemotherapy with one of XELOX or FOLFOX regimens. Evaluation of the response to treatment is done 12-16 weeks after the end of the treatment by MRI and colonoscopy. If there is a good response to the treatment, chemotherapy is continued until 16 weeks are completed and then a re-evaluation similar to the first evaluation is done. will be Patients with a complete clinical response will enter the Watch and Wait protocol if the patient agrees and other conditions are met (regular visit for follow-up and surgeon's approval).
Main outcome variables
The rate of tumor regression in MRI and colonoscopy/complete clinical response in patients/increasing the probability of not needing surgery in patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150929024266N6
Registration date:2024-02-24, 1402/12/05
Registration timing:registered_while_recruiting
Last update:2024-02-24, 1402/12/05
Update count:0
Registration date
2024-02-24, 1402/12/05
Registrant information
Name
Reza Ghalehtaki
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2520
Email address
r-ghaletaki@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-06, 1402/10/16
Expected recruitment end date
2025-12-26, 1404/10/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the rate of complete clinical response following total neoadjuvant therapy by using chemoradiotherapy by Intensity modulated radiation therapy with simultaneous integrated boost (IMRT-SIB) in patients with lower rectal cancer; a Phase II randomized clinical trial
Public title
Investigating the clinical response rate of patients with lower rectal cancer after combined treatment with intensity-modulated chemoradiotherapy and pre-surgical chemotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Non-metastatic rectal cancer (>T2N0) that is less than 5 cm from the anal wedge
Exclusion criteria:
Inability to do MRI (whether mechanical or claustrophobia)
Lack of proper MRI for disease staging
Multiple comorbidities
Inadequate blood, kidney, or liver indices for the possibility of receiving chemotherapy
History of previous malignancies in the pelvis or other areas of the intestine, history of previous surgeries or radiotherapy in the pelvic area
MSI-H patients who are candidates for immunotherapy
History of IBD or FAP and other colon polyposis syndromes
Active malignancies in other areas of the body.
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine- Tehran University of Medical Sciences
Street address
Poursina Street, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2023-12-01, 1402/09/10
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.484
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
The rate of clinical response in MRI and colonoscopy
Timepoint
12 to 16 weeks after completion of treatment
Method of measurement
Reduction in size or complete disappearance of mass in MRI and colonoscopy
Secondary outcomes
empty
Intervention groups
1
Description
The target population is people over 18 years of age with non-metastatic rectal cancer that are less than 5 cm from the anus and have good clinical conditions.Patients undergoing radiotherapy using 25-66/57 GTV, SIB and 25/45 CTV will receive five days a week (Saturday to Wednesday) and will be treated with chemotherapy regimen with Xeloda 825 2m/mg twice a day orally between The first to fourteenth days will be arranged. SIB-PTV will be gross tumor on MRI plus 1 cm of geometric margin. After radiotherapy, T3/4 or N+ patients undergo chemotherapy with one of XELOX or FOLFOX regimens. Examining the results of patients 12-16 weeks after the end of treatment will be done by MRI and colonoscopy.The MRI report must be reviewed by two people separately or reported by an experienced person. If there is a good response to the treatment and the tumor has decreased in size significantly, the chemotherapy is continued until 16 weeks are completed, and then a re-evaluation similar to the first evaluation is done. Patients with complete clinical response enter the Wait and W protocol if the patient agrees and other conditions are met (regular follow-up visits and surgeon's approval).Complete response means the absence of residual activity in MRI and the absence of tumor, ulcer or polyp in colonoscopy. If there is no suitable response, the patient will be referred for surgery and the rest of the chemotherapy will be done after the operation.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex, cancer institute
Full name of responsible person
Reza Ghaletaki
Street address
Keshavarz Blvd. Gharib St. Imam Khomeini Hospital Complex, Cancer institute
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2585
Fax
+98 21 6658 1604
Email
isnr.group@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari-Sari
Street address
No 206, First Floor, Official Building, Medical Faculty, Poursina Street, 16th Azar Street, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1461884513
Phone
+98 21 81631
Email
research@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of Research, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Reza Ghalehtaki
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2520
Fax
+98 21 6119 2520
Email
r-ghaletaki@student.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reza Ghalehtaki
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2520
Fax
+98 21 6119 2520
Email
r-ghaletaki@student.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reza Ghalehtaki
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2520
Fax
+98 21 6119 2520
Email
r-ghaletaki@student.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available