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

NCT ID: NCT05920928

Last Updated: 2023-06-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-23
• Study Completion Date: 2025-04-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: RADIATION

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

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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)

Interventions

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)

Intervention Type: RADIATION

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

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

Intervention Type: RADIATION

Other Intervention Names

Short term radiotherapy (25Gy in 5Fr); Long term radiotherapy (50.4Gy in 28Fr)

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tehran University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

IR.TUMS.IKHC.REC. 9911880002

Identifier Type: -

Identifier Source: org_study_id