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.
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
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
Parallel
SCRT : 25 Gy in 5 fractions over 1 week to the pelvis using IGRT technique
RadiationArm 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
RadiationArm 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
Pathological complete response (pCR) rate measured in proportion of participants (%)
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 (%)
Local Recurrence Rate measured in percentage of participants (%)
Proportion of participants experiencing loco-regional relapse, defined as reappearance of tumor at the primary site or regional lymph nodes, as confirmed by clinical evaluation and imaging (pelvic MRI or CT scan) at specified intervals post-treatment. Unit of Measure: Percentage of participants (%)
Overall Survival (OS) in months
Overall survival is defined as the time from randomization to death from any cause. Participants who are alive at the time of analysis or are lost to follow-up will be censored at the last date known to be alive. Outcome will be summarized using median survival and survival rates at specified time points. Unit of Measure: Time in months
Acute Toxicities graded using CTCAE version 5.0
All adverse events occurring during RT and chemotherapy up to 3 months post-surgery
Late Toxicities documented using clinician assessment and patient reported outcomes EORTC QLQ-C30 and QLQ-CR29
Number and proportion of participants experiencing treatment-related adverse effects arising between 6 months and 2 years post-treatment, including bowel dysfunction (e.g., frequency, urgency), bladder dysfunction (e.g., incontinence, retention), and sexual dysfunction. Assessment will be performed through standardized clinician evaluation and patient-reported outcome measures using validated questionnaires. Unit of Measure: Percentage of participants (%)
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