Anal CancerROAR-ANCT05438836
Re-optimization Based Online Adaptive Radiotherapy of Anal Cancer
An observational study of Anal Cancer and Anal Carcinoma, run by Herlev Hospital at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Cancer, Anal Carcinoma, Anal Squamous Cell Carcinoma
- What is being tested?
- online adaptive radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 205 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2022to 1 Jan 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with non-metastatic squamous cell carcinoma of the anus, referred for chemo-radiotherapy with curative intent.
Who may be able to join
- Biopsy-verified anal cancer
- Eligible for curative intended radiotherapy
- Written and oral consent
Who cannot join
- Other malignant disease within the past 5 years (excluding basal cell carcinoma)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Oncology dept, Herlev and Gentofte Hospital
Herlev, 2730
Eva S Serup-Hansen, MD, PhD, +4538689084, eva.serup-hansen@regionh.dk
katrine s Storm, MD, +4538686269, katrine.smedegaard.storm@regionh.dk
About this study
Official title: 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).
- Conditions
- Anal Cancer, Anal Carcinoma, Anal Squamous Cell Carcinoma
- Being tested
- online adaptive radiotherapy
- Keywords
- adaptive radiotherapy, Anal cancer, Online Adaptive radiotherapy (oART)
- Medical subject headings
- Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online adaptive radiotherapyRadiation
Also called Varian Ethos Adaptive Radiation Therapy
Online adaptive radiotherapy compared to standard non-adaptive Image-Guided Radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Online adaptive radiotherapy | Daily online adaptive radiotherapy Receives: Radiation: online adaptive radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Rate of Common Terminology Criteria for Adverse Events (CTCAE) Gastrointestinal Toxicity grade 2 or more (scale from 0-5, 5 being the highest)
percentage of patients with grade 2 or more early treatment-related Gastrointestinal-toxicity
Measured: from mid-treatment to 3 months after end of treatment
Secondary outcomes (8)
All Early Common Terminology Criteria for Adverse Events (CTCAE) Treatment Related Toxicities. Grade 1-5 (5 being the highest)
percentage of patients with grade 2 or more early treatment-related toxicity
Measured: from mid-treatment to 3 months after end of treatment
All Late Common Terminology Criteria for Adverse Events (CTCAE) Treatment Related Toxicities
percentage of patients with grade 2 or more late treatment-related toxicity
Measured: From 3 months after end of treatment to 5 years follow-up
Patient Reported Outcomes (PRO)
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
Measured: from baseline to 5 years follow-up
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Assessment
Collection ofEuropean Organisation for Research and Treatment of Cancer (EORTC) Quality of life questionnaire C30
Measured: from baseline to 5 years follow-up
Progression Free Survival
Progression free survival (from time of inclusion to disease progression)
Measured: From time of inclusion to disease progression, assessed up to 5 years follow-up
Overall Survival
Overall survival
Measured: From time of inclusion to death from any cause, assessed up to 5 years follow-up
Disease Free Survival
Disease Free Survival
Measured: From time of inclusion to death from bladder cancer, assessed up to 5 years follow-up
Treatment Related Hospitalization
Hospitalization due to radiation therapy treatment related toxicity
Measured: From of start of radiation therapy through 5 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start1 Jan 2022
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 205 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Serup-Hansen, Herlev Hospital
- Investigators
- Eva S Serup-Hansen, MD, PhD, Principal investigator, Herlev og Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438836
- Sponsor's protocol ID
- H-21028093
- Acronym
- ROAR-A
- Status last verified
- Sep 2023
- First submitted
- 27 Jun 2022
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38528456
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROAR-A: Re-optimization Based Online Adaptive Radiotherapy of Anal Cancer
- ClinicalTrials.gov ID
- NCT05438836
- Acronym / sponsor ID
- ROAR-A / H-21028093
- Conditions
- Anal Cancer, Anal Carcinoma, Anal Squamous Cell Carcinoma
- Keywords
- adaptive radiotherapy, Anal cancer, Online Adaptive radiotherapy (oART)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 205 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2031 (estimated)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Online adaptive radiotherapy | – | Radiation: online adaptive radiotherapyDaily online adaptive radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-metastatic squamous cell carcinoma of the anus, referred for chemo-radiotherapy with curative intent.
Key inclusion criteria (3 listed)
- Biopsy-verified anal cancer
- Eligible for curative intended radiotherapy
- Written and oral consent
Key exclusion criteria (1 listed)
- Other malignant disease within the past 5 years (excluding basal cell carcinoma)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| online adaptive radiotherapyAlso: Varian Ethos Adaptive Radiation TherapyOnline adaptive radiotherapy compared to standard non-adaptive Image-Guided Radiotherapy | Radiation | Online adaptive radiotherapy |
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)
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
8 secondary outcomes
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
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
Patient Reported Outcomes (PRO)
Time frame: 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
Progression Free Survival
Time frame: 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
Disease Free Survival
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Derived from this study: PubMed 38528456Storm 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eva S Serup-Hansen, MD, PhD principal investigator
Herlev og Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Cancer and Anal Carcinoma, run by Herlev Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eva Serup-Hansen, MD, PhD (+4538689084, eva.serup-hansen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05438836, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.