Anal CancerPhase 2ReRad IIINCT05055635
Pencil Beam Proton Therapy for Recurrences in Anal Cancer Patients Previously Treated With Radiotherapy (DACG 5)
A Phase 2 study testing Pencil beam proton therapy in people with Anal Cancer and Recurrent Anal Cancer, run by University of Aarhus at 1 site in Denmark.
Trial summary
This protocol aims to determine toxicity and efficacy of re-irradiation for patients with recurrences from anal cancers with dose-escalated pencil beam proton therapy either pre-operative for marginally resectable recurrences or as a definitive treatment strategy (un-resectable, operation declined etc.). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Cancer, Recurrent Anal Cancer
- What is being tested?
- Pencil beam proton therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Jul 2021to 6 Jul 2030
- Phase
- Phase 2
- 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
Who may be able to join
- Recurrent anal cancer
- Bioptically verified (squamous cell carcinoma)
- Available dose plan from primary radiotherapy
- Previous RT (>30Gy EQD2)
- Evaluated in MDT-conferences (Herlev, Aarhus)
- Age>18 years
Show all 9Show fewer
- PS 0-2
- Adequate organ function
- Written informed consent
Who cannot join
- Distant metastases deemed without curative intended treatment options (PET-CT)
- Unable to undergo MRI, PET-CT
- Inability to attend full course radiotherapy and follow up in the outpatient clinic.
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
Danish Centre for Particle Therapy
Aarhus N, Aarhus, 8200
Camilla Kronborg, MD, PhD, +45 7845 0000, camkro@rm.dk
About this study
Official title: ReRad III. Pencil Beam Proton Therapy for Recurrences in Anal Cancer Patients Previously Treated With Radiotherapy
This protocol aims to determine toxicity and efficacy of re-irradiation for patients with recurrences from anal cancers with dose-escalated pencil beam proton therapy either pre-operative for marginally resectable recurrences or as a definitive treatment strategy (un-resectable, operation declined etc.). The over-all aim is to improve local tumor control with acceptable side effects.
- Conditions
- Anal Cancer, Recurrent Anal Cancer
- Being tested
- Pencil beam proton therapy
- Medical subject headings
- Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pencil beam proton therapyRadiation
Neo-adjuvant or definitive pencil beam proton therapy: 55 Gy(RBE)/44fx - 65 Gy(RBE)/52 fx (1.25 Gy per fraction), two fractions a day
| Study group | Role | What they receive |
|---|---|---|
| Doseescalated pencil beam proton therapy | Experimental | Neo-adjuvant or definitive pencil beam proton therapy: 55 Gy(RBE)/44fx - 65 Gy(RBE)/52 fx (1.25 Gy per fraction), two fractions a day. Receives: Radiation: Pencil beam proton therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local control
MRI
Measured: 12 months
Secondary outcomes (13)
Local re-recurrence
Measured: 6 and 24 months
Progression free survival
Measured: 3-5 year FU
Overall survival
Measured: 3-5 year FU
Pathological evaluation of R0, R1 or R2 resection
Measured: 6 months
Toxicity
evaluated by NCI-CTCAE v. 5.0
Measured: up to 6 weeks, 1 year, 3 year
Quality of life assessment
EORTC QLQ-c30
Measured: up to 6 weeks, 1 year, 3 year
Quality of life assessment
QLQ-CR29
Measured: up to 6 weeks, 1 year, 3 year
Quality of life assessment
QLQ-ANL27
Measured: up to 6 weeks, 1 year, 3 year
Quality of life assessment
LARS score
Measured: up to 6 weeks, 1 year, 3 year
Translational research
cfDNA
Measured: baseline, end of therapy, 1 year
Summed radiotherapy dose volume to organs at risk and correlation to toxicities
Measured: up to 6 weeks, 1 year, 3 year
To investigate 30-day surgical overall morbidity
Clavien-Dindo
Measured: 30-day
To investigate 6-month surgical site morbidity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start7 Jul 2021
- Primary completion6 Jul 2027 (estimated)
- Study completion6 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055635
- Sponsor's protocol ID
- DCPT070721
- Acronym
- ReRad III
- Status last verified
- Jul 2021
- First submitted
- 8 Jul 2021
- Last updated
- 24 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ReRad III. Pencil Beam Proton Therapy for Recurrences in Anal Cancer Patients Previously Treated With Radiotherapy
- ClinicalTrials.gov ID
- NCT05055635
- Acronym / sponsor ID
- ReRad III / DCPT070721
- Conditions
- Anal Cancer, Recurrent Anal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 6 Jul 2027 (estimated)
- Study completion
- 6 Jul 2030 (estimated)
- First posted
- 24 Sep 2021 (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.
This protocol aims to determine toxicity and efficacy of re-irradiation for patients with recurrences from anal cancers with dose-escalated pencil beam proton therapy either pre-operative for marginally resectable recurrences or as a definitive treatment strategy (un-resectable, operation declined etc.). The over-all aim is to improve local tumor control with acceptable side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Doseescalated pencil beam proton therapy | Experimental | Radiation: Pencil beam proton therapyNeo-adjuvant or definitive pencil beam proton therapy: 55 Gy(RBE)/44fx - 65 Gy(RBE)/52 fx (1.25 Gy per fraction), two fractions a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Recurrent anal cancer
- Bioptically verified (squamous cell carcinoma)
- Available dose plan from primary radiotherapy
- Previous RT (>30Gy EQD2)
- Evaluated in MDT-conferences (Herlev, Aarhus)
Key exclusion criteria (3 listed)
- Distant metastases deemed without curative intended treatment options (PET-CT)
- Unable to undergo MRI, PET-CT
- Inability to attend full course radiotherapy and follow up in the outpatient clinic.
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 |
|---|---|---|
| Pencil beam proton therapyNeo-adjuvant or definitive pencil beam proton therapy: 55 Gy(RBE)/44fx - 65 Gy(RBE)/52 fx (1.25 Gy per fraction), two fractions a day | Radiation | Doseescalated pencil beam proton therapy |
Primary outcome
Local control
Time frame: 12 months
MRI
13 secondary outcomes
Local re-recurrence
Time frame: 6 and 24 months
Progression free survival
Time frame: 3-5 year FU
Overall survival
Time frame: 3-5 year FU
Pathological evaluation of R0, R1 or R2 resection
Time frame: 6 months
Toxicity
Time frame: up to 6 weeks, 1 year, 3 year
Quality of life assessment
Time frame: up to 6 weeks, 1 year, 3 year
Quality of life assessment
Time frame: up to 6 weeks, 1 year, 3 year
Quality of life assessment
Time frame: up to 6 weeks, 1 year, 3 year
Quality of life assessment
Time frame: up to 6 weeks, 1 year, 3 year
Translational research
Time frame: baseline, end of therapy, 1 year
Summed radiotherapy dose volume to organs at risk and correlation to toxicities
Time frame: up to 6 weeks, 1 year, 3 year
To investigate 30-day surgical overall morbidity
Time frame: 30-day
To investigate 6-month surgical site morbidity
Time frame: 6 months
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 24 Sep 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pencil beam proton therapy in people with Anal Cancer and Recurrent Anal Cancer, run by University of Aarhus 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 9 inclusion and 3 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 24 Sep 2021. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Camilla Kronborg, MD, PhD (+45 78 45 00 00, camkro@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local control (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Sep 2021.