Comparison of the Clinical Response of Total nEoadjuvant Treatment of Two Methods of Long-term or Short-term cHemoRadiotherapy Followed by Consolidation Chemotherapy in Patients With Locally Advanced rectAl Cancer (TEHRAN) , a Randomized Controlled Clinical Trial
The purpose of this research is to compare two methods of TNT radiation therapy with same chemotherapy regimen.
Design
This study is a phase two tial, the sample size was estimated to be 114 based on similar trials, and then the patients were randomly divided into two groups.
Settings and conduct
Patients are treated with radiotherapy and chemotherapy at the Cancer Institution of Imam Khomeini Hospital
Participants/Inclusion and exclusion criteria
Patients who are referred to the Cancer Institute between September 2023 and the end of March 2024, who has rectal adenocarcinoma from 5 cm to 15 cm from the anal verge and is Node positive or T3 and T4 based on MRI or EUS.In case of any other chemotherapy or radiotherapy treatment, will be disregarded in the trial.
Intervention groups
Group1: Long course radiotherapy with concurrent capecitabine(825mg/m2)
Radiation is administered in conjunction with concomitant capecitabine (825mg/m2)
group2: Short course radiotherapy with concurrent capecitabine(825mg/m2)
Compared to conventional treatments, short-term radiotherapy has lower fraction numbers but higher radiation doses per fraction
Main outcome variables
Evaluation of complete clinical response rate after neoadjuvant treatment with MRI and colonoscopy
General information
Reason for update
Acronym
TEHRAN
IRCT registration information
IRCT registration number:IRCT20230604058384N1
Registration date:2023-06-14, 1402/03/24
Registration timing:prospective
Last update:2023-06-14, 1402/03/24
Update count:0
Registration date
2023-06-14, 1402/03/24
Registrant information
Name
Seyed Masoud Miratashi Yazdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8163 3626
Email address
masoudssu@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Clinical Response of Total nEoadjuvant Treatment of Two Methods of Long-term or Short-term cHemoRadiotherapy Followed by Consolidation Chemotherapy in Patients With Locally Advanced rectAl Cancer (TEHRAN) , a Randomized Controlled Clinical Trial
Public title
Comparison of the Clinical Response of Total Neoadjuvant Treatment of Two Methods of Long-term or Short-term Chemoradiotherapy in Rectal Cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Locally advanced (T3-4, N+)adenocarcinoma of rectum is located 5 to 15 cm from anal verge
is located 5 to 15 cm from anal verge
Exclusion criteria:
Familial syndromes e.g. lynch
Previous history of cancer
Previous history of chemotherapy
Recurrent disease
Metastatic disease
Inability to perform MRI (Claustrophobia or prosthetic valve)
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
114
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization the permuted block randomization method was employed, in which blocks of four parts were formed, and the sequence where each part was assigned to each group was determined by random numbers. The randomization process was carried out using the web based application sealedenvelope.com.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
For the treatment of rectal cancer, there are primarily two radiation techniques. Long-term radiotherapy is 50.4 Gy delivered in 28 fractions, while short-term radiotherapy is 25 Gy delivered in 5 parts. These two approaches have not before been compared to one another, and the goal of the study is to accomplish just that.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Imam Khomeini Hospital Complex- Tehran University of Medical Sciences
Intervention group: Long-course radiation therapy with a dose of 50.4 Gy in 28 sessions along with concurrent chemotherapy with capecitabine at a dose of 825 mg/m2 and then consolidation chemotherapy with XELOX regimen for 6 cycles
Category
Treatment - Other
2
Description
Intervention group: Short-course radiation therapy with a dose of 25 Gy in 5 sessions along with concurrent chemotherapy with capecitabine at a dose of 825 mg/m2 and then consolidation chemotherapy with XELOX regimen for 6 cycles
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
the risk that the original authors could not exploit the entire potential of the data they obtained, possible failures in patients’ privacy protection, technical barriers such as the lack of standard formats, and possible data misinterpretation