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

NCT ID: NCT07258797

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2029-03-31

Brief 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.

Detailed Description

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.

Conditions

Adenocarcinoma of the Rectum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SCRT + Consolidation Chemotherapy

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).

Group Type: ACTIVE_COMPARATOR

SCRT : 25 Gy in 5 fractions over 1 week to the pelvis using IGRT technique

Intervention Type: RADIATION

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

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).

Group Type: ACTIVE_COMPARATOR

LCRT + Consolidation Chemotherapy

Intervention Type: RADIATION

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

Interventions

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

Intervention Type: RADIATION

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

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rajiv Gandhi Cancer Institute & Research Center, India

OTHER

Sponsor Role: lead

Responsible Party

Shaifali Goel

Consultant, Department of Gastrointestinal and Hepatobiliary services

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jaskaran Sethi, MD

Role: STUDY_DIRECTOR

Rajiv Gandhi Cancer Hospital and Research Centre, New Delhi

Locations

Rajiv Gandhi Cancer Institute and Research Centre

New Delhi, , India

Countries

India

Central Contacts

Shivendra Singh, MCh

Role: CONTACT

drshivendraonco@gmail.com

919818975024

Facility Contacts

Shaifali Goel, DrNB SG

Role: primary

doctor.shaifali@gmail.com

918368382060

References

Bahadoer RR, Dijkstra EA, van Etten B, Marijnen CAM, Putter H, Kranenbarg EM, Roodvoets AGH, Nagtegaal ID, Beets-Tan RGH, Blomqvist LK, Fokstuen T, Ten Tije AJ, Capdevila J, Hendriks MP, Edhemovic I, Cervantes A, Nilsson PJ, Glimelius B, van de Velde CJH, Hospers GAP; RAPIDO collaborative investigators. Short-course radiotherapy followed by chemotherapy before total mesorectal excision (TME) versus preoperative chemoradiotherapy, TME, and optional adjuvant chemotherapy in locally advanced rectal cancer (RAPIDO): a randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Jan;22(1):29-42. doi: 10.1016/S1470-2045(20)30555-6. Epub 2020 Dec 7.

Reference Type: BACKGROUND

PMID: 33301740 (View on PubMed)

Other Identifiers

RGCIRC/IRB-BHR/52/2025

Identifier Type: -

Identifier Source: org_study_id