Clinical trial · Interventional
Intraoperative Electron Radiotherapy in Rectal Cancer - A Feasibility Trial
NCT05877352CI-TRIAL-00111607ELECTRAactive not recruitingN/AClinicalTrials.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)
Single centre double-blinded three-arm randomised controlled trial of extended margin surgery + IOERT at standard dose (10 Gy) versus extended margin surgery + IOERT at higher dose (15 Gy) versus extended margin surgery alone in a 1:1:1 ratio in patients with Locally Advanced Rectal Cancer (LARC) or Locally Recurrent Rectal Cancer (LRRC).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Locally Recurrent Rectal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Extended Margin Surgery | Procedure | — | UNRESOLVED |
| Intraoperative Electron Radiotherapy (IOERT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- No IOERT
- description
- Extended margin surgery
- interventionNames
- Procedure: Extended Margin Surgery
- type
- EXPERIMENTAL
- label
- Low Dose IOERT
- description
- Extended margin surgery and IOERT at standard dose (10 Gy)
- interventionNames
- Radiation: Intraoperative Electron Radiotherapy (IOERT)
- Procedure: Extended Margin Surgery
- type
- EXPERIMENTAL
- label
- High Dose IOERT
- description
- Extended margin surgery and IOERT at higher dose (15 Gy)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 16 * Non-metastatic/oligo-metastatic (up to 3 lesions from 2 sites predicted to be radically treatable) - locally advanced or locally recurrent disease involving the posterior or lateral components of the pelvis and predicted to be resectable but with close margins from imaging as determined by a specialist MDT (sMDT) * Colorectal sMDT review with experience in pelvic exenteration, which has proposed IntrOperative Electron Radiotherapy (IOERT) as an option for treatment * Patient suitable for IOERT as component of treatment in the view of the responsible Clinical Oncologist * Performance status ≤1 as defined by the Eastern Cooperative Oncology Group (ECOG) * Deemed medically fit for surgery * Written informed consent Exclusion Criteria: * Unresectable disease/likelihood of R2 resection * sMDT determined excess prior radiotherapy within IOERT target zone * Women who are pregnant or breastfeeding * Participation within an interventional clinical trial within 3 months of the point of registration within ELECTRA
References
Publications (0)
Data not yet available
No reference posted for this study.