Pencil beam proton therapy for recurrent anal cancer
Official title: ReRad III. Pencil Beam Proton Therapy for Recurrences in Anal Cancer Patients Previously Treated With Radiotherapy
Run by University of Aarhus · NCT05055635 · Data updated 2026-11-12
This study is testing a new type of proton therapy for people with recurrent anal cancer to see if it can help control the tumor better while causing fewer side effects.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 55 (estimated) |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Aarhus N, Aarhus) |
| Status | Recruiting |
| Started | July 7, 2021 |
| Main results expected | July 6, 2027 |
| Study ends | July 6, 2030 |
| Registry record updated | September 24, 2021 |
| Trial ID | NCT05055635 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old with bioptically verified recurrent anal squamous cell carcinoma who have previously received radiation therapy.
✕Probably not a fit
Patients with distant metastases or those unable to undergo necessary imaging studies or complete the treatment regimen may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the safety and effectiveness of dose-escalated pencil beam proton therapy in patients with recurrent anal cancer who have previously undergone radiotherapy. The approach aims to improve local tumor control while minimizing side effects, using proton therapy either as a pre-operative treatment for marginally resectable cases or as a definitive treatment for those who are un-resectable or have declined surgery. Participants must have a confirmed diagnosis of squamous cell carcinoma and meet specific eligibility criteria, including prior radiation exposure and adequate organ function.
Why it matters
Potential benefit: If successful, this treatment could provide improved local control of anal cancer recurrences with fewer side effects compared to traditional therapies.
How similar studies have gone: While this approach is innovative, similar studies using proton therapy for other cancers have shown promising results, suggesting potential for success in this context.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * PS 0-2 * Adequate organ function * Written informed consent Exclusion Criteria: * 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.
Where it's running
-
Danish Centre for Particle Therapy
Aarhus N, Aarhus, Denmark Recruiting
Study contacts
- Study coordinator: Camilla Kronborg, MD, PhD
- Email: camkro@rm.dk
- Phone: +45 78 45 00 00
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.