Comparing Shorter and Longer Radiotherapy Before Surgery for Advanced Rectal Cancer
Compares two radiotherapy schedules given before surgery in adults with locally advanced rectal cancer.
Plain-language title generated from the registry record
Registry title: Short Course or Long Course Radiotherapy as Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer
Key facts
- Where
- New Delhi, IndiaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07258797, who can take part
Where in India
- Rajiv Gandhi Cancer Institute And Research CentreNew Delhi, IndiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Rajiv Gandhi Cancer Institute & Research Center, India
- Trial code
- NCT07258797
- Record updated
- 2 December 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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; Hemoglobin ≥ 9 g/dL; Absolute neutrophil count ≥ 1,500/mm³; Platelets ≥ 100,000/mm³; Total bilirubin ≤ 1.5 × ULN; Aspartate transaminase/Alanine transaminase ≤ 2.5 × ULN; Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min; Fit for neoadjuvant therapy and curative resection; Willing and able to provide written, informed consent; Baseline MRI and biopsy (even if done outside) must be reviewed and approved by the institutional radiology and pathology review board, requiring concurrence from two independent pathologists and two independent radiologists.
Exclusion: Prior pelvic radiotherapy or systemic chemotherapy for rectal cancer; Metastatic disease at presentation (distant nodes, liver, lung, peritoneum, etc.); 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; Severe comorbid conditions precluding therapy (e.g., decompensated cardiac, hepatic, or renal disease); Psychiatric illness or social situations that may limit compliance with study requirements; Pregnant or breastfeeding women; Inability to comply with protocol requirements or follow-up schedule.