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Recruiting NCT05055635

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

Phase II Interventional Anal Cancer Recurrent Anal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pencil beam proton therapy.
Who it may be relevant to
Registry conditions: Anal Cancer, Recurrent Anal Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Radiation Pencil 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

Primary outcome measures

  • Local control [Time frame: 12 months]
Secondary outcome measures (12)
  • Local re-recurrence [Time frame: 6 and 24 months]
  • Progression free survival [Time frame: 3-5 year FU]
  • Overall survival [Time frame: 3-5 year FU]
  • Pathological evaluation of R0, R1 or R2 resection [Time frame: 6 months]
  • Toxicity [Time frame: up to 6 weeks, 1 year, 3 year]
  • Quality of life assessment [Time frame: up to 6 weeks, 1 year, 3 year]
  • Quality of life assessment [Time frame: up to 6 weeks, 1 year, 3 year]
  • Quality of life assessment [Time frame: up to 6 weeks, 1 year, 3 year]
  • Quality of life assessment [Time frame: up to 6 weeks, 1 year, 3 year]
  • Translational research [Time frame: baseline, end of therapy, 1 year]
  • Summed radiotherapy dose volume to organs at risk and correlation to toxicities [Time frame: up to 6 weeks, 1 year, 3 year]
  • To investigate 30-day surgical overall morbidity [Time frame: 30-day]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • Danish Centre for Particle Therapy — Aarhus N

Identifiers

NCT: NCT05055635 · DCPT070721

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗