Adenocarcinoma of the RectumSHOOLNCT07258797
Short Course or Long Course Radiotherapy as Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer
A study testing SCRT : 25 Gy in 5 fractions over 1 week to the pelvis using IGRT technique and LCRT + Consolidation Chemotherapy in people with Adenocarcinoma of the Rectum, run by Rajiv Gandhi Cancer Institute & Research Center, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adenocarcinoma of the Rectum
- What is being tested?
- SCRT : 25 Gy in 5 fractions over 1 week to the pelvis using IGRT technique and LCRT + Consolidation Chemotherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIndia
- Study dates
- 1 Dec 2025to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
- Severe comorbid conditions precluding therapy (e.g., decompensated cardiac, hepatic, or renal disease)
- Pregnant or breastfeeding women
- Inability to comply with protocol requirements or follow-up schedule
- Psychiatric illness or social situations that may limit compliance with study requirements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
Rajiv Gandhi Cancer Institute and Research Centre
New Delhi, 110085
Shaifali Goel, DrNB SG, 918368382060, doctor.shaifali@gmail.com
About this study
Official title: 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.
Read the 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
- Being tested
- SCRT : 25 Gy in 5 fractions over 1 week to the pelvis using IGRT technique, LCRT + Consolidation Chemotherapy
- Keywords
- SHORT COURSE RADIOTHERAPY, LONG COURSE RADIOTHERAPY, RECTAL CANCER, OUTCOMES, SURVIVAL
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCRT : 25 Gy in 5 fractions over 1 week to the pelvis using IGRT techniqueRadiation
Arm A - SCRT + Consolidation Chemotherapy
- Radiotherapy: 25 Gy in 5 fractions over 1 week to the pelvis using IGRT technique.
- Interval before Chemotherapy: 1-2 weeks after completion of radiotherapy.
- 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 ChemotherapyRadiation
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 group | Role | What they receive |
|---|---|---|
| SCRT + Consolidation Chemotherapy | Active comparator | 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). Receives: Radiation: SCRT : 25 Gy in 5 fractions over 1 week to the pelvis using IGRT technique |
| LCRT + Consolidation Chemotherapy | Active comparator | 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). Receives: Radiation: LCRT + Consolidation Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%)
Measured: 3 and 5 years
Secondary outcomes (6)
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 (%)
Measured: 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
Measured: 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
Measured: 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 (%)
Measured: 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 (%)
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adenocarcinoma of the RectumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rajiv Gandhi Cancer Institute & Research Center, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaifali Goel, Rajiv Gandhi Cancer Institute & Research Center, India
- Investigators
- Jaskaran Sethi, MD, Study director, Rajiv Gandhi Cancer Hospital and Research Centre, New Delhi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258797
- Sponsor's protocol ID
- RGCIRC/IRB-BHR/52/2025
- Acronym
- SHOOL
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data sets will include participant demographics, baseline measures, intervention details, clinical outcomes, and adverse events recorded during the study.
Publications
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.
PubMed 33301740
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07258797
- Acronym / sponsor ID
- SHOOL / RGCIRC/IRB-BHR/52/2025
- Conditions
- Adenocarcinoma of the Rectum
- Keywords
- SHORT COURSE RADIOTHERAPY, LONG COURSE RADIOTHERAPY, RECTAL CANCER, OUTCOMES, SURVIVAL
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Rajiv Gandhi Cancer Institute & Research Center, IndiaUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCRT + Consolidation Chemotherapy | Active comparator | Radiation: SCRT : 25 Gy in 5 fractions over 1 week to the pelvis using IGRT techniqueRadiotherapy: 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). |
| LCRT + Consolidation Chemotherapy | Active comparator | Radiation: LCRT + Consolidation ChemotherapyRadiotherapy: 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (8 listed)
- 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
- Severe comorbid conditions precluding therapy (e.g., decompensated cardiac, hepatic, or renal disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCRT : 25 Gy in 5 fractions over 1 week to the pelvis using IGRT techniqueArm 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 | Radiation | SCRT + Consolidation Chemotherapy |
| LCRT + Consolidation ChemotherapyArm 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 | Radiation | LCRT + Consolidation Chemotherapy |
Primary outcome
Pathological complete response (pCR) rate measured in proportion of participants (%)
Time frame: 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 (%)
6 secondary outcomes
Local Recurrence Rate measured in percentage of participants (%)
Time frame: 3 and 5 years
Overall Survival (OS) in months
Time frame: Evaluated at 3 years and 5 years
Acute Toxicities graded using CTCAE version 5.0
Time frame: 3 months post surgery
Late Toxicities documented using clinician assessment and patient reported outcomes EORTC QLQ-C30 and QLQ-CR29
Time frame: 6 months to 2 years post-treatment
Treatment completion Rate measured in percentage of participants (%)
Time frame: 1 year
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Background: PubMed 33301740Bahadoer 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.
- Individual participant dataSharing planned: Yes. De-identified data sets will include participant demographics, baseline measures, intervention details, clinical outcomes, and adverse events recorded during the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jaskaran Sethi, MD study director
Rajiv Gandhi Cancer Hospital and Research Centre, New Delhi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCRT : 25 Gy in 5 fractions over 1 week to the pelvis using IGRT technique and LCRT + Consolidation Chemotherapy in people with Adenocarcinoma of the Rectum, run by Rajiv Gandhi Cancer Institute & Research Center, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shivendra Singh, MCh (919818975024, drshivendraonco@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (pCR) rate measured in proportion of participants (%) (time frame: 3 and 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07258797, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.