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Clinical Trials in India / NCT07258797
Starting soon Not applicable

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

NCT07258797 · tracked via the Priya Life Science India tracker
Sponsor
Rajiv Gandhi Cancer Institute & Research Center, India
Phase
Not applicable
Started
2025-12-01
Last updated
2025-12-02

Condition(s) studied

Adenocarcinoma of the Rectum

Investigational drug(s) / intervention(s)

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

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

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Histologically confirmed adenocarcinoma of the rectum 2. Locally advanced disease based on MRI including cT3-T4 and/or node positive disease (cN1 or N2) 3. Tumor located within 15 cm from the anal verge (confirmed by endoscopy or MRI) 4. ECOG performance status 0-2 5. Hemoglobin ≥ 9 g/dL 6. Absolute neutrophil count ≥ 1,500/mm³ 7. Platelets ≥ 100,000/mm³ 8. Total bilirubin ≤ 1.5 × ULN 9. Aspartate transaminase/Alanine transaminase ≤ 2.5 × ULN 10. Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min 11. Fit for neoadjuvant therapy and curative resection 12. Willing and able to provide written, informed consent 13. 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 Criteria: 1. Metastatic disease at presentation (distant nodes, liver, lung, peritoneum, etc.) 2. Prior pelvic radiotherapy or systemic chemotherapy for rectal cancer 3. 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 4. Known HIV infection with CD4 \< 200 cells/μL, or active hepatitis B or C 5. Severe comorbid conditions precluding therapy (e.g., decompensated cardiac, hepatic, or renal disease) 6. Pregnant or breastfeeding women 7. Inability to comply with protocol requirements or follow-up schedule 8. Psychiatric illness or social situations that may limit compliance with study requirements

Primary outcome measure(s)

  • Pathological complete response (pCR) rate measured in proportion of participants (%) — 3 and 5 years
    Proportion of participants achieving pathological complete response, defined as ypT0N0 on histopathological examination of resected tumor specimens after surgery. Assessment will be performed by institutional pathologists according to standardized reporting guidelines. The pCR rate is central to evaluating early tumor response to total neoadjuvant therapy. Unit of Measure: Proportion of participants (%)

Trial sites (1)

FacilityCityRegionStatus
Rajiv Gandhi Cancer Institute and Research Centre New Delhi India

More Rajiv Gandhi Cancer Institute & Research Center, India trials in India

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07258797 on ClinicalTrials.gov ↗ ← All trials in India