Clinical trial · Interventional
A Prospective Single Arm Study of Intraoperative Radiotherapy for Locally Advanced or Recurrent Rectal Cancer
NCT01493206CI-TRIAL-00090409completedPhase 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 hypothesis is that intraoperative radiotherapy for locally advanced or recurrent rectal cancer improve outcomes without causing significant side effects.
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 |
|---|---|---|---|
| Malignant Rectal Neoplasm | Malignant Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Recurrent Tumor | Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intraoperative radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- intraoperative radiotherapy
- interventionNames
- Radiation: intraoperative radiotherapy
Primary outcomes (1)
- measure
- clinical outcomes
- timeFrame
- 3-year
- description
- locoregional control, progression-free and overall survival rates.
Secondary outcomes (1)
- measure
- toxicities
- timeFrame
- 3-6 monthly up to 30 months
- description
- Toxicity score criteria defined by Intraoperative Radiation Therapy Working Group Criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * locally advanced or recurrent rectal cancer * suitable for radical surgery but at high risk of positive resection margins, * no evidence of metastasis, * age greater than 18 years, * histologically confirmed adenocarcinoma, * ECOG performance status \<2. * Informed consent Exclusion Criteria: * unresectable pelvic disease * distant metastasis * significant co-morbidities
References
Publications (0)
Data not yet available
No reference posted for this study.