Clinical trial · Interventional
Local Excision of Clinical T3 Rectal Adenocarcinoma Showing Major Response(ycT0-1) After Neoadjuvant Chemoradiotherapy
Local Excision of Clinical T3 Mid- or Low-Rectal Adenocarcinoma Showing Major Response(ycT0-1) After Neoadjuvant Chemoradiotherapy: Prospective Multicenter Single-arm Phase II Clinical Trial
NCT02490709CI-TRIAL-00018462unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is evaluation of the safety and the efficacy of transanal local excision in patients with cT3 rectal cancer which was downstaged into ycT0-1 after neoadjuvant chemoradiotherapy.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Local excision | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Local excision
- description
- Local excision for rectal cancer with good response
- interventionNames
- Procedure: Local excision
Primary outcomes (1)
- measure
- 3-year disease free survival
- timeFrame
- 1-5 years
- description
- Death or recurrence as an event
Secondary outcomes (2)
- measure
- Complete response rate
- timeFrame
- 1-5 years
- description
- The rate of complete response of the tumor after neoadjuvant chemoradiotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * age: more than 20 years * biopsy-proven adenocarcinoma of the rectum * clinical staging, cT3NxM0 * Rectal cancer located 8 cm from the anal verge * Restaging in 6-10 weeks after completion of neoadjuvant chemoradiotherapy, ycT0-1N0M0 * ECOG performance status 2 or less Exclusion Criteria: * Synchronous colon cancer or other malignancy * Obstructing rectal cancer * Pregnant or breast-feeding * Receiving any other study agents * History of prior colorectal cancer or inflammatory bowel disease * Hereditary colorectal cancer (FAP, HNPCC)
References
Publications (0)
Data not yet available
No reference posted for this study.