Clinical trial · Interventional
Adaptive Individualized High-Dose Radiotherapy Analysis-REctum-1 (AIDA-RE-1)
AIDA-RE-1: Adaptive Individualized Hig-Dose Radiotherapy Analysis-Rectum-1. Interventional Study on Neoadjuvant Adaptive-treatment of High Risk Rectal Cancer
NCT03479814CI-TRIAL-00032256unknownN/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)
Aim of the study is to evaluate achievement of complete pathologic response (pCR) in high-risk rectal cancer treated with neoadjuvant concomitant chemotherapy plus adaptive-intensity modulated imaging-guided radiotherapy
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoadjuvant Treatment | — | UNRESOLVED | — |
| Radiotherapy | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMRT-SIB plus sequential IG-RT boost | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IMRT-SIB plus sequential IG-RT boost
- description
- 45 Gy plus 5 Gy concomitant boost are delivered to rectum and locoregional lymphnodes (25 fractions); sequential IG-RT (imaging guided-radiotherapy) boost of 5 Gy in 2 fractions is planned with 18-FDG-PET
- interventionNames
- Radiation: IMRT-SIB plus sequential IG-RT boost
Primary outcomes (1)
- measure
- complete pathological response (pCR)
- timeFrame
- 6 weeks
- description
- pCR is defined as ypT0N0
Secondary outcomes (5)
- measure
- Acute toxicity
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histologically confirmed diagnosis of locally advanced rectal cancer (cT3N+, cT4Nx, local relapse, cT3N0); cT2N+ is acceptable if low rectum is involved * M0 * ECOG 0-2 Exclusion Criteria: * M1 * familial adenomatous polyposis (FAP), non-polyposis hereditary colorectal cancer, inflammatory bowel disease * severe cardiopathy * previous pelvic RT
References
Publications (0)
Data not yet available
No reference posted for this study.