Re-optimization Based Online Adaptive Radiotherapy of Anal Cancer

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Brief Title

Re-optimization Based Online Adaptive Radiotherapy of Anal Cancer

Official Title

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

Brief Summary

      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).

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Early Rate of Common Terminology Criteria for Adverse Events (CTCAE) Gastrointestinal Toxicity grade 2 or more (scale from 0-5, 5 being the highest)

Secondary Outcome

 All Early Common Terminology Criteria for Adverse Events (CTCAE) Treatment Related Toxicities. Grade 1-5 (5 being the highest)

Condition

Anal Cancer

Intervention

online adaptive radiotherapy

Study Arms / Comparison Groups

 Online adaptive radiotherapy
Description:  Daily online adaptive radiotherapy

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Radiation

Estimated Enrollment

205

Start Date

January 1, 2022

Completion Date

January 1, 2031

Primary Completion Date

January 1, 2026

Eligibility Criteria

        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)

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Eva S Serup-Hansen, MD, PhD, +4538689084, [email protected]

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations

NCT ID

NCT05438836

Organization ID

H-21028093

Responsible Party

Principal Investigator

Study Sponsor

Herlev Hospital

Study Sponsor

Eva S Serup-Hansen, MD, PhD, Principal Investigator, Herlev og Gentofte Hospital

Verification Date

August 2022