Clinical trial · Interventional
Sphincter-preserving Surgery After Preoperative Treatment of Ultra-low Rectal Carcinoma
Phase II Trial Comparing Two Neoadjuvant Treatments in Patients With Ultra-low Rectal Cancer: High-dose Radiotherapy Versus Radio-chemotherapy
- 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 phase III trial included patients with low rectal adenocarcinoma which initially required APR, with a mean clinical distance between the tumor inferior pole and the levator ani of 0.5 cm. Patients were randomly assigned to receive high-dose radiation (45 + 18 Gy) or radiochemotherapy (45 Gy + 5FU continuous infusion). The surgical decision was based on the tumor status at surgery. All surgeons used a homogenous SSR technique such as intersphincteric resection. The primary endpoint was the SSR rate.
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 Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemo-radiotherapy | Radiation | — | UNRESOLVED |
| High-Dose radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- High-dose Radiotherapy
- interventionNames
- Radiation: High-Dose radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Chemo-radiotherapy
- interventionNames
- Radiation: Chemo-radiotherapy
Primary outcomes (1)
- measure
- Sphincter preservation rate
- timeFrame
- surgery
Secondary outcomes (7)
- measure
- Tumor response according to rectal endo-echography
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adenocarcinoma of ultra-low rectum at high risk of abdomino-périneal amputation * Tumor classified as EER UT2-UT3, whatever the nodal status * pathological confirmation of rectal adenocarcinoma without evidence of distant metastasis (M0), T2 or T3 resectable tumors without striated sphincter involvement and with the inferior margin of the tumor located less than 2 cm from the upper part of the levator ani. * Age 18 years or older * Informed and written consent Exclusion Criteria: * T1 * T4 (proven invasion of sphincter) * Diffuse metastatic syndrome (no curative intent, short expected life span) * preoperative incontinence (non due to the tumor)
References
Publications (0)
Data not yet available