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

Sponsor

Tehran University of Medical Sciences (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05920928

Collaborator

(none)

114

Enrollment

Arms

18.3

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Locally Advanced Rectal Carcinoma	Radiation: Short course radiotherapy with concurrent capecitabine(825mg/m2) Radiation: Long course radiotherapy with concurrent capecitabine(825mg/m2)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

114 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Sep 23, 2023

Anticipated Primary Completion Date :

Aug 31, 2024

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Clinical complete response [Week]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Tehran University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tehran University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT05920928

Other Study ID Numbers:

IR.TUMS.IKHC.REC. 9911880002

First Posted:

Jun 27, 2023

Last Update Posted:

Jun 27, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Rectal Neoplasms

Capecitabine

Study Results

No Results Posted as of Jun 27, 2023