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

Not Applicable

Not yet recruiting

• Conditions: Locally Advanced Rectal Carcinoma
• Interventions: Radiation: Long course radiotherapy with concurrent capecitabine(825mg/m2); Radiation: Short course radiotherapy with concurrent capecitabine(825mg/m2)

• Registration Number: NCT05920928
• Lead Sponsor: Tehran University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-05
• Study First Submitted QC: 2023-06-24
• Last Update Submitted: 2023-06-24
• Study First Posted: 2023-06-27
• Last Update Posted: 2023-06-27
• Study Start: 2023-09-23
• Primary Completion: 2024-08-31
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 114

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Long course chemoRadiotherapy (50.4Gy in 28 fr)	Long course radiotherapy with concurrent capecitabine(825mg/m2)	Neoadjuvant Long course radiotherapy (50.4 Gy in 28 fr) with concurrent capecitabine (825mg/m2) for locally advanced rectal cancer
Short course chemoRadiotherapy (25Gy in 5 fr)	Short course radiotherapy with concurrent capecitabine(825mg/m2)	Neoadjuvant short course radiotherapy (25 Gy in 5 fr) with concurrent capecitabine (825mg/m2) for locally advanced rectal cancer

Primary Outcome Measures

Name	Time	Method
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.