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

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University of Aarhus

Status and phase

Enrolling
Phase 2

Conditions

Anal Cancer
Recurrent Anal Cancer

Treatments

Radiation: Pencil beam proton therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05055635
DCPT070721

Details and patient eligibility

About

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.

Enrollment

55 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

55 participants in 1 patient group

Doseescalated pencil beam proton therapy
Experimental group
Description:
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.
Treatment:
Radiation: Pencil beam proton therapy

Trial contacts and locations

1

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Central trial contact

Camilla Kronborg, MD, PhD

Data sourced from clinicaltrials.gov

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