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

September 21, 2023 updated by: Eva Serup-Hansen, Herlev Hospital

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

205

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Herlev, Denmark, 2730
        • Recruiting
        • Oncology dept, Herlev and Gentofte Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eva Serup-Hansen, MD, PhD
        • Sub-Investigator:
          • katrine S Storm, MD
        • Sub-Investigator:
          • Anna-Lene Fromm, MD
        • Sub-Investigator:
          • Laura V Diness, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with non-metastatic squamous cell carcinoma of the anus, referred for chemo-radiotherapy with curative intent.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early Rate of Common Terminology Criteria for Adverse Events (CTCAE) Gastrointestinal Toxicity grade 2 or more (scale from 0-5, 5 being the highest)
Time Frame: from mid-treatment to 3 months after end of treatment
percentage of patients with grade 2 or more early treatment-related Gastrointestinal-toxicity
from mid-treatment to 3 months after end of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All Early Common Terminology Criteria for Adverse Events (CTCAE) Treatment Related Toxicities. Grade 1-5 (5 being the highest)
Time Frame: from mid-treatment to 3 months after end of treatment
percentage of patients with grade 2 or more early treatment-related toxicity
from mid-treatment to 3 months after end of treatment
All Late Common Terminology Criteria for Adverse Events (CTCAE) Treatment Related Toxicities
Time Frame: From 3 months after end of treatment to 5 years follow-up
percentage of patients with grade 2 or more late treatment-related toxicity
From 3 months after end of treatment to 5 years follow-up
Patient Reported Outcomes (PRO)
Time Frame: 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
from baseline to 5 years follow-up
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Assessment
Time Frame: from baseline to 5 years follow-up
Collection ofEuropean Organisation for Research and Treatment of Cancer (EORTC) Quality of life questionnaire C30
from baseline to 5 years follow-up
Progression Free Survival
Time Frame: From time of inclusion to disease progression, assessed up to 5 years follow-up
Progression free survival (from time of inclusion to disease progression)
From time of inclusion to disease progression, assessed up to 5 years follow-up
Overall Survival
Time Frame: From time of inclusion to death from any cause, assessed up to 5 years follow-up
Overall survival
From time of inclusion to death from any cause, assessed up to 5 years follow-up
Disease Free Survival
Time Frame: From time of inclusion to death from bladder cancer, assessed up to 5 years follow-up
Disease Free Survival
From time of inclusion to death from bladder cancer, assessed up to 5 years follow-up
Treatment Related Hospitalization
Time Frame: From of start of radiation therapy through 5 year follow-up
Hospitalization due to radiation therapy treatment related toxicity
From of start of radiation therapy through 5 year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herlev Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2031

Study Registration Dates

First Submitted

June 27, 2022

First Submitted That Met QC Criteria

June 27, 2022

First Posted (Actual)

June 30, 2022

Study Record Updates

Last Update Posted (Actual)

September 25, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-21028093

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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