Re-optimization Based Online Adaptive Radiotherapy of Anal Cancer

NCT ID: NCT05438836

Last Updated: 2023-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

205 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2031-01-01

Brief Summary

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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).

Detailed Description

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Conditions

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Anal Cancer Anal Carcinoma Anal Squamous Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Online adaptive radiotherapy

Daily online adaptive radiotherapy

online adaptive radiotherapy

Intervention Type RADIATION

Online adaptive radiotherapy compared to standard non-adaptive Image-Guided Radiotherapy

Interventions

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online adaptive radiotherapy

Online adaptive radiotherapy compared to standard non-adaptive Image-Guided Radiotherapy

Intervention Type RADIATION

Other Intervention Names

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Varian Ethos Adaptive Radiation Therapy

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Herlev Hospital

OTHER

Sponsor Role lead

Responsible Party

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Eva Serup-Hansen

Clinical oncologist, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eva S Serup-Hansen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Herlev og Gentofte Hospital

Locations

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Oncology dept, Herlev and Gentofte Hospital

Herlev, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Eva Serup-Hansen, MD, PhD

Role: CONTACT

+4538689084

katrine S storm, MD

Role: CONTACT

+4538686269

Facility Contacts

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Eva S Serup-Hansen, MD, PhD

Role: primary

+4538689084

katrine s Storm, MD

Role: backup

+4538686269

References

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Storm 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.

Reference Type DERIVED
PMID: 38528456 (View on PubMed)

Other Identifiers

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H-21028093

Identifier Type: -

Identifier Source: org_study_id

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