An interventional study of SCRT : 25 Gy in 5 fractions over 1 week to the pelvis using IGRT technique and LCRT + Consolidation Chemotherapy in Adenocarcinoma of the Rectum, sponsored by Rajiv Gandhi Cancer Institute & Research Center, India. Not yet recruiting at 1 site in India. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Rajiv Gandhi Cancer Institute & Research Center, India · Not applicable, Interventional, and Treatment
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.
The SHOOL study is a single-institution, open-label, randomized prospective study designed to evaluate and compare two internationally accepted total neoadjuvant therapy (TNT) strategies in patients with locally advanced rectal cancer (LARC). These strategies differ primarily in their radiotherapy schedule and include:
Arm A: Short-course radiotherapy (SCRT; 25 Gy in 5 fractions over 1 week), followed by consolidation chemotherapy and surgery
Arm B: Long-course chemoradiotherapy (LCRT; 50.4 Gy in 28 fractions with concurrent Capecitabine over 5-5.5 weeks), followed by consolidation chemotherapy and surgery The study acronym "SHOOL" reflects the clinical dilemma of whether SHOrt-course Or Long-course radiotherapy offers better or more practical outcomes when delivered within a TNT framework.
This prospective study aims to explore how these two strategies compare in terms of tumour response (as measured by pathological complete response, pCR), toxicity, treatment compliance, feasibility, quality of life, and local recurrence rates at 3 and 5 years. Given that both arms represent evolving standards of care, this study is designed to generate real-world data that can guide institutional decision-making and inform future definitive trials.
1,761 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's planned enrollment of 150 is above the median of 65 across 1,297 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Rajiv Gandhi Cancer Institute & Research Center, India is the lead sponsor of 25 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Radiotherapy: 25 Gy in 5 fractions over 1 week to the pelvis using IGRT technique. 1. Interval before Chemotherapy: 1-2 weeks after completion of radiotherapy. 2. Chemotherapy: Modified FOLFOX6 every 2 weeks (total of 12 cycles).
Radiation: SCRT : 25 Gy in 5 fractions over 1 week to the pelvis using IGRT technique
Radiotherapy: 1. Primary tumor and involved nodes: 50 Gy in 25 fractions. 2. Elective nodal basin: 45 Gy in 25 fractions. Delivered concurrently with oral Capecitabine (825 mg/m² twice daily on radiotherapy days).
Radiation: LCRT + Consolidation Chemotherapy
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
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
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 (%)
Time frame: 3 and 5 years
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 (%)
Time frame: 3 and 5 years
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
Time frame: Evaluated at 3 years and 5 years
Acute Toxicities graded using CTCAE version 5.0
All adverse events occurring during RT and chemotherapy up to 3 months post-surgery
Time frame: 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 (%)
Time frame: 6 months to 2 years post-treatment
Treatment completion Rate measured in percentage of participants (%)
Proportion of participants who complete the planned treatment regimen, including radiotherapy (RT), chemotherapy cycles, and surgery. Reasons for any deviations from the planned treatment, such as toxicity, patient refusal, or disease progression, will be documented and analyzed. Unit of Measure: Percentage of participants (%)
Time frame: 1 year
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Assessed by the proportion of participants adhering to the treatment protocol as planned, rates of treatment delays or dose reductions due to adverse events, and multidisciplinary team (MDT) decision-making trends regarding treatment modifications. These measures collectively evaluate the practical implementation and patient tolerance of the therapeutic regimen. Unit of Measure: Percentage of participants (%) and descriptive trends
Time frame: 1 year
Plan to share: Yes — De-identified data sets will include participant demographics, baseline measures, intervention details, clinical outcomes, and adverse events recorded during the study.
Supporting information: Study protocol, Icf
This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Rajiv Gandhi Cancer Institute & Research Center, India