NCT05055635 Pencil Beam Proton Therapy for Recurrences in Anal Cancer Patients Previously Treated With Radiotherapy (DACG 5)
| NCT ID | NCT05055635 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Aarhus |
| Condition | Anal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 55 participants |
| Start Date | 2021-07-07 |
| Primary Completion | 2027-07-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 55 participants in total. It began in 2021-07-07 with a primary completion date of 2027-07-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.). The over-all aim is to improve local tumor control with acceptable side effects.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05055635 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05055635 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05055635 currently recruiting?
Yes, NCT05055635 is actively recruiting participants. Contact the research team at camkro@rm.dk for enrollment information.
Where is the NCT05055635 trial being conducted?
This trial is being conducted at Aarhus N, Denmark.
Who is sponsoring the NCT05055635 clinical trial?
NCT05055635 is sponsored by University of Aarhus. The trial plans to enroll 55 participants.
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