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

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)

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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