Pencil beam proton therapy for recurrent anal cancer
ReRad III. Pencil Beam Proton Therapy for Recurrences in Anal Cancer Patients Previously Treated With Radiotherapy
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 |
| Enrollment | 55 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Aarhus N, Aarhus) |
| Trial ID | NCT05055635 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with bioptically verified recurrent anal squamous cell carcinoma who have previously received radiation therapy.
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.
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 performed: While this approach is innovative, similar studies using proton therapy for other cancers have shown promising results, suggesting potential for success in this context.
Eligibility criteria
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 this trial is running
Aarhus N, Aarhus
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.