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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Locally Advanced Rectal Carcinoma
• Intervention / Treatment: Radiation: Long course radiotherapy with concurrent capecitabine(825mg/m2); Radiation: Short course radiotherapy with concurrent capecitabine(825mg/m2)

• Study Type: Interventional
• Enrollment (Estimated): 114
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Long course chemoRadiotherapy (50.4Gy in 28 fr); Neoadjuvant Long course radiotherapy (50.4 Gy in 28 fr) with concurrent capecitabine (825mg/m2) for locally advanced rectal cancer	Radiation: Long course radiotherapy with concurrent capecitabine(825mg/m2); Long-term radiation is administered in conjunction with concomitant capecitabine (825mg/m2); Other Names: Long term radiotherapy (50.4Gy in 28Fr)
Experimental: Short course chemoRadiotherapy (25Gy in 5 fr); Neoadjuvant short course radiotherapy (25 Gy in 5 fr) with concurrent capecitabine (825mg/m2) for locally advanced rectal cancer	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); Other Names: Short term radiotherapy (25Gy in 5Fr)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tehran University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): September 23, 2023
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: June 5, 2023
• First Submitted That Met QC Criteria: June 24, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 24, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine
• Other Study ID Numbers: IR.TUMS.IKHC.REC. 9911880002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No