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NCT05920928 Clinical Trial

Comparison of the Clinical Response of Total Neoadjuvant Treatment of Two Methods of Long-term or Short-term Chemoradiotherapy in Rectal Cancer

Locally Advanced Rectal Carcinoma Clinical Trial

— TEHRAN  

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05920928
Other study ID # IR.TUMS.IKHC.REC. 9911880002
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 23, 2023
Est. completion date April 1, 2025

Study information
Verified date June 2023
Source Tehran University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Rectal cancer is one of the most prevalent malignancies in the world, and its prevalence is rising. In more advanced cases neoadjuvant therapy is advised before to surgery, and radiotherapy is one of its cornerstones. 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. In earlier studies, these two radiation techniques were combined with various chemotherapy drugs, and a relative comparison was established. Total neoadjuvant treatment, or TNT, has been linked to a better outcome because of the significance of organ preservation. The aim of this research is to compare two TNT radiation techniques with the same regimen of treatment.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 114
Est. completion date April 1, 2025
Est. primary completion date August 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: Locally advanced (T3-4, N+)adenocarcinoma of rectum that 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)

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• 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. capecitabine is given during treatment time (825mg/m2)
• Long course radiotherapy with concurrent capecitabine(825mg/m2)
Long-term radiation is administered in conjunction with concomitant capecitabine (825mg/m2)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Tehran University of Medical Sciences

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical complete response At the 18th week following the start of the treatment, the patient will be assessed. The evaluation consist of an MRI and a colonoscopy, with a PET scan being optional. Week
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