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

NCT05920928 | Unknown

• 1 other identifier: IR.TUMS.IKHC.REC. 9911880002
• Study Type: interventional
• Target: 114
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Locally Advanced Rectal Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Long course chemoRadiotherapy (50.4Gy in 28 fr)

EXPERIMENTAL

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)

Short course chemoRadiotherapy (25Gy in 5 fr)

EXPERIMENTAL

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)

Interventions

Short course radiotherapy with concurrent capecitabine(825mg/m2) RADIATION

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)

Also known as: Short term radiotherapy (25Gy in 5Fr)

Short course chemoRadiotherapy (25Gy in 5 fr)

Long course radiotherapy with concurrent capecitabine(825mg/m2) RADIATION

Long-term radiation is administered in conjunction with concomitant capecitabine (825mg/m2)

Also known as: Long term radiotherapy (50.4Gy in 28Fr)

Long course chemoRadiotherapy (50.4Gy in 28 fr)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Locally advanced (T3-4, N+)adenocarcinoma of rectum that is located 5 to 15 cm from anal verge .

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Related Publications (1)

• Aghili M, Ghalehtaki R, Yaghooti-Khorasani M, Yazdi SMM, Kolahdouzan K. Comparison of the Clinical Response in Total Neoadjuvant Treatment With Long-Term or Short-Term Chemoradiotherapy Followed by Consolidation Chemotherapy in Patients With Locally Advanced Rectal Cancer (TEHRAN); the Protocol for a Randomized Controlled Clinical Trial. Cancer Med. 2025 Dec;14(24):e71472. doi: 10.1002/cam4.71472.

  PMID: 41412957 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 27, 2023
• Study Start: September 23, 2023
• Primary Completion: August 31, 2024
• Study Completion: April 1, 2025
• Last Updated: June 27, 2023

Record last verified: 2023-06