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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRajiv Gandhi Cancer Institute & Research Center, India

About this trial

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.

Eligibility criteria

Qualifiers

Histologically confirmed adenocarcinoma of the rectum

Locally advanced disease based on MRI including cT3-T4 and/or node positive disease (cN1 or N2)

Tumor located within 15 cm from the anal verge (confirmed by endoscopy or MRI)

ECOG performance status 0-2

Disqualifiers

Metastatic disease at presentation (distant nodes, liver, lung, peritoneum, etc.)

Prior pelvic radiotherapy or systemic chemotherapy for rectal cancer

Presence of synchronous malignancies or previous malignancy within 5 years except: Treated basal cell or squamous cell carcinoma of the skin, In situ cervical cancer, Active uncontrolled infection

Known HIV infection with CD4 < 200 cells/μL, or active hepatitis B or C

Trial design

Treatments tested in this trial

  • SCRT : 25 Gy in 5 fractions over 1 week to the pelvis using IGRT technique
  • LCRT + Consolidation Chemotherapy

Treatment groups

150 Participants
are divided into 2 treatment groups