Clinical trial · Observational
Re-optimization Based Online Adaptive Radiotherapy of Anal Cancer
ROAR-A: Re-optimization Based Online Adaptive Radiotherapy of Anal Cancer
NCT05438836CI-TRIAL-00069891ROAR-ArecruitingClinicalTrials.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)
A single-arm, prospective, Phase II, single-center clinical trial that will investigate if daily online adaptive radiotherapy for anal cancer will significantly reduce early treatment-related GI toxicity compared with the historically reported rate for non-adaptive intensity modulated radiation therapy (IMRT).
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 |
|---|---|---|---|
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
| Anal Carcinoma | Anal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Anal Squamous Cell Carcinoma | Anal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| online adaptive radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Online adaptive radiotherapy
- description
- Daily online adaptive radiotherapy
- interventionNames
- Radiation: online adaptive radiotherapy
Primary outcomes (1)
- measure
- Early Rate of Common Terminology Criteria for Adverse Events (CTCAE) Gastrointestinal Toxicity grade 2 or more (scale from 0-5, 5 being the highest)
- timeFrame
- from mid-treatment to 3 months after end of treatment
- description
- percentage of patients with grade 2 or more early treatment-related Gastrointestinal-toxicity
Secondary outcomes (8)
- measure
- All Early Common Terminology Criteria for Adverse Events (CTCAE) Treatment Related Toxicities. Grade 1-5 (5 being the highest)
- timeFrame
- from mid-treatment to 3 months after end of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy-verified anal cancer * Eligible for curative intended radiotherapy * Written and oral consent Exclusion Criteria: * Other malignant disease within the past 5 years (excluding basal cell carcinoma)
References
Publications (1)
- DERIVEDStorm KS, Astrom LM, Sibolt P, Behrens CP, Persson GF, Serup-Hansen E. ROAR-A: re-optimization based Online Adaptive Radiotherapy of anal cancer, a prospective phase II trial protocol. BMC Cancer. 2024 Mar 25;24(1):374. doi: 10.1186/s12885-024-12111-1. PMID 38528456