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NOT YET RECRUITING
NCT07258797
NA

Short Course or Long Course Radiotherapy as Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer

Sponsor: Rajiv Gandhi Cancer Institute & Research Center, India

View on ClinicalTrials.gov

Summary

This study compares two standard radiotherapy approaches (short-course vs. long-course) given before surgery in patients with locally advanced rectal cancer. The goal is to see which treatment is more effective and better tolerated.

Official title: Short Course or Long Course Radiotherapy as Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer : A Prospective, Open Label, Single Institution, Randomized, Parallel Arm Comparative Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2025-12-01

Completion Date

2029-03-31

Last Updated

2025-12-02

Healthy Volunteers

No

Interventions

RADIATION

SCRT : 25 Gy in 5 fractions over 1 week to the pelvis using IGRT technique

Arm A - SCRT + Consolidation Chemotherapy 1. Radiotherapy: 25 Gy in 5 fractions over 1 week to the pelvis using IGRT technique. 2. Interval before Chemotherapy: 1-2 weeks after completion of radiotherapy. 3. Chemotherapy: Modified FOLFOX6 every 2 weeks (total of 12 cycles). If the patient is fit, the option of intensifying the chemo to mFOLFIRINOX will be discussed with the patient

RADIATION

LCRT + Consolidation Chemotherapy

Arm B - LCRT + Consolidation Chemotherapy 1) Radiotherapy: o Primary tumor and involved nodes: 50 Gy in 25 fractions. o Elective nodal basin: 45 Gy in 25 fractions. Delivered concurrently with oral Capecitabine (825 mg/m² twice daily on radiotherapy days). o Technique: IGRT 2) Interval before Chemotherapy: 1-2 weeks after completion of chemoradiotherapy. 3) Chemotherapy: Modified FOLFOX6

Locations (1)

Rajiv Gandhi Cancer Institute and Research Centre

New Delhi, India