RecruitingPhase 2NCT05055635

Pencil Beam Proton Therapy for Recurrences in Anal Cancer Patients Previously Treated With Radiotherapy (DACG 5)

ReRad III. Pencil Beam Proton Therapy for Recurrences in Anal Cancer Patients Previously Treated With Radiotherapy


Sponsor

University of Aarhus

Enrollment

55 participants

Start Date

Jul 7, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria9

  • 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 Criteria3

  • 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.

Interventions

RADIATIONPencil beam proton therapy

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


Locations(1)

Danish Centre for Particle Therapy

Aarhus N, Aarhus, Denmark

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NCT05055635


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