Pencil Beam Proton Therapy for Recurrences in Anal Cancer Patients Previously Treated With Radiotherapy (DACG 5)
Recruiting
Phase 2Interventional Study
Anal CancerRecurrent Anal Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
55 (estimated)
Sponsor
University of Aarhus · Other
Who this trial is looking for
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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.
Trial Locations
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Status
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
Exc…
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.
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