Evidence map›Paper›PMID 38528456›Full record

ArticleBMC cancer2024

ROAR-A: re-optimization based Online Adaptive Radiotherapy of anal cancer, a prospective phase II trial protocol.

Katrine Smedegaard Storm, Lina M Åström, Patrik Sibolt, Claus P Behrens, Gitte F Persson, Eva Serup-Hansen

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05438836 (ROAR-A), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.7field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05438836 recruitingnot on this map

ROAR-A: Re-optimization Based Online Adaptive Radiotherapy of Anal Cancer

TypeobservationalSponsorHerlev HospitalRan2022 to 2031Enrolled205ConditionsAnal Cancer, Anal Carcinoma, Anal Squamous Cell CarcinomaArmsonline adaptive radiotherapy
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. Review
  2. Innovative radiotherapy approaches.ESMO gastrointestinal oncology · 2026
    Review
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Katrine Smedegaard StormDepartment of Oncology, Copenhagen University Hospital - Herlev and Gentofte, Herlev, Denmark. Katrine.smedegaard.storm@regionh.dk.
Lina M ÅströmDepartment of Oncology, Copenhagen University Hospital - Herlev and Gentofte, Herlev, Denmark.
Patrik SiboltDepartment of Oncology, Copenhagen University Hospital - Herlev and Gentofte, Herlev, Denmark.
Claus P BehrensDepartment of Oncology, Copenhagen University Hospital - Herlev and Gentofte, Herlev, Denmark.
Gitte F PerssonDepartment of Oncology, Copenhagen University Hospital - Herlev and Gentofte, Herlev, Denmark.
Eva Serup-HansenDepartment of Oncology, Copenhagen University Hospital - Herlev and Gentofte, Herlev, Denmark.
Gentofte Hospital · DKUniversity of Copenhagen · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChemo-radiotherapy with curative intent for anal cancer has high complete remission rates, but acute treatment-related gastrointestinal (GI) toxicity is significant. Toxicity occurs due to irradiation of surrounding normal tissue. Current radiotherapy requires the addition of large planning margins to the radiation field to ensure target coverage regardless of the considerable organ motion in the pelvic region. This increases the irradiated volume and radiation dose to the surrounding normal tissue and thereby toxicity. Online adaptive radiotherapy uses artificial intelligence to adjust the treatment to the anatomy of the day. This allows for the reduction of planning margins, minimizing the irradiated volume and thereby radiation to the surrounding normal tissue.This study examines if cone beam computed tomography (CBCT)-guided oART with daily automated treatment re-planning can reduce acute gastrointestinal toxicity in patients with anal cancer. METHODS/

designThe study is a prospective, single-arm, phase II trial conducted at Copenhagen University Hospital, Herlev and Gentofte, Denmark. 205 patients with local only or locally advanced anal cancer, referred for radiotherapy with or without chemotherapy with curative intent, are planned for inclusion. Toxicity and quality of life are reported with Common Terminology Criteria of Adverse Events and patient-reported outcome questionnaires, before, during, and after treatment. The primary endpoint is a reduction in the incidence of acute treatment-related grade ≥ 2 diarrhea from 36 to 25% after daily online adaptive radiotherapy compared to standard radiotherapy. Secondary endpoints include all acute and late toxicity, overall survival, and reduction in treatment interruptions.

resultsAccrual began in January 2022 and is expected to finish in January 2026. Primary endpoint results are expected to be available in April 2026. DISCUSSION: This is the first study utilizing online adaptive radiotherapy to treat anal cancer. We hope to determine whether there is a clinical benefit for the patients, with significant reductions in acute GI toxicity without compromising treatment efficacy.

trial registrationClinicalTrials.gov Identifier: NCT05438836. Danish Ethical Committee: H-21028093.

Indexed as

Anus NeoplasmsRadiotherapy, Image-GuidedRadiotherapy, Intensity-ModulatedArtificial IntelligenceClinical Trials, Phase II as TopicDiarrheaHumansProspective StudiesQuality of LifeRadiotherapy DosageRadiotherapy Planning, Computer-AssistedTreatment OutcomeAnal cancerChemoradiotherapyCT-guided adaptive radiotherapyDaily adaptive radiotherapyOnline adaptive radiotherapy

Identifiers

PMID38528456
PMCPMC10962183
OpenAlexW4393163626

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.