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

Sponsor
Herlev Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05438836
Collaborator
(none)
205
Enrollment
1
Location
1
Arm
108
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Radiation: online adaptive radiotherapy
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
205 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
ROAR-A: Re-optimization Based Online Adaptive Radiotherapy of Anal Cancer
Actual Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2026
Anticipated Study Completion Date :
Jan 1, 2031

Arms and Interventions

Arm Intervention/Treatment
Experimental: Online adaptive radiotherapy

Daily online adaptive radiotherapy

Radiation: online adaptive radiotherapy
Online adaptive radiotherapy compared to standard non-adaptive Image-Guided Radiotherapy
Other Names:
  • Varian Ethos Adaptive Radiation Therapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Early Rate of Common Terminology Criteria for Adverse Events (CTCAE) Gastrointestinal Toxicity grade 2 or more (scale from 0-5, 5 being the highest) [from mid-treatment to 3 months after end of treatment]

      percentage of patients with grade 2 or more early treatment-related Gastrointestinal-toxicity

    Secondary Outcome Measures

    1. All Early Common Terminology Criteria for Adverse Events (CTCAE) Treatment Related Toxicities. Grade 1-5 (5 being the highest) [from mid-treatment to 3 months after end of treatment]

      percentage of patients with grade 2 or more early treatment-related toxicity

    2. All Late Common Terminology Criteria for Adverse Events (CTCAE) Treatment Related Toxicities [From 3 months after end of treatment to 5 years follow-up]

      percentage of patients with grade 2 or more late treatment-related toxicity

    3. Patient Reported Outcomes (PRO) [from baseline to 5 years follow-up]

      Collection of National Cancer Institute Patient Reported Outcome-Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE) questionnaire (scale from none to a lot) and comparison to Common Terminology Criteria for Adverse Events (CTCAE) and dosimetry data

    4. European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Assessment [from baseline to 5 years follow-up]

      Collection ofEuropean Organisation for Research and Treatment of Cancer (EORTC) Quality of life questionnaire C30

    5. Progression Free Survival [From time of inclusion to disease progression, assessed up to 5 years follow-up]

      Progression free survival (from time of inclusion to disease progression)

    6. Overall Survival [From time of inclusion to death from any cause, assessed up to 5 years follow-up]

      Overall survival

    7. Disease Free Survival [From time of inclusion to death from bladder cancer, assessed up to 5 years follow-up]

      Disease Free Survival

    8. Treatment Related Hospitalization [From of start of radiation therapy through 5 year follow-up]

      Hospitalization due to radiation therapy treatment related toxicity

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oncology dept, Herlev and Gentofte Hospital Herlev Denmark 2730

    Sponsors and Collaborators

    • Herlev Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eva Serup-Hansen, Clinical oncologist, MD, PhD, Herlev Hospital
    ClinicalTrials.gov Identifier:
    NCT05438836
    Other Study ID Numbers:
    • H-21028093
    First Posted:
    Jun 30, 2022
    Last Update Posted:
    Aug 4, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Eva Serup-Hansen, Clinical oncologist, MD, PhD, Herlev Hospital
    adaptive radiotherapy
    Anal cancer
    Online Adaptive radiotherapy (oART)
    Additional relevant MeSH terms:
    Carcinoma
    Anus Neoplasms

    Study Results

    No Results Posted as of Aug 4, 2022