Clinical trial · Interventional
Non-operative Management for Locally Advanced Rectal Cancer
Phase II Study to Assess the Safety of Non-operative Management for Low Rectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a 5 year Phase II study to evaluate the safety of non-operative management (NOM) in patients with low rectal cancer (LRC) who achieve a complete clinical response (cCR) following chemoradiotherapy (CRT). The safety of NOM will be evaluated by assessing (i) rate of local re-growth and (ii) rate of macroscopically positive resection margin (R2) when surgery is required due to local re-growth. NOM will be considered safe or as effective as surgery to achieve local control if the rate of local re-growth is equal to or less than 30% and the rate of a macroscopically positive margin is 0%.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-operative management | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- non-operative management
- description
- Patients with low rectal cancer who have achieved a complete clinical response following chemoradiotherapy will undergo active follow-up with regular clinical visits, physical exam, endoscopy and imaging assessments at regular intervals for 2 years to assess for tumour re-growth or spread to the liver and lungs
- interventionNames
- Procedure: Non-operative management
Primary outcomes (2)
- measure
- Rate of local re-growth
- timeFrame
- 2 years
- description
- The safety of non-operative management will be evaluated by assessing the rate of local re-growth in the study population. This approach will be considered safe if the local re-growth rate is equal to or less than 30%.
- measure
- Rate of macroscopically positive resection margin
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Completed chemoradiotherapy (CRT) as standard of care \[Stage II and Stage III (T3-T4N0, AnyTN1-2)\]; \[50 Gy (2 Gy x 25 fractions) with 5-FU or capecitabine\] * Planned or probable APR * ALL criteria for complete clinical response are met between 8 and 10 weeks following completion of CRT * 18 years or older * Provides written consent Exclusion Criteria: * Unable to undergo MRI * Metastatic disease (including extramesorectal and retroperitoneal lymph nodes) * Pregnancy * Inflammatory bowel disease * More than one primary colorectal cancer * Other malignancy within 5 years of treatment for current rectal cancer * Unfit for surgery
References
Publications (1)
- DERIVEDKennedy ED, Schmocker S, Brown C, Liberman S, Baxter NN, Drolet S, Neumann K, Simunovic M, Richard C, Brezden-Masley C, Jhaveri K, Kopek N, Kirsch R. Nonoperative management protocol for locally advanced rectal cancer. Colorectal Dis. 2024 Jun;26(6):1285-1291. doi: 10.1111/codi.17035. Epub 2024 May 26. PMID 38797916