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

University of Aarhus1 site in 1 country55 target enrollmentJuly 7, 2021

ConditionsAnal Cancer Recurrent Anal Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Anal Cancer
Sponsor: University of Aarhus
Enrollment: 55
Locations: 1
Primary Endpoint: Local control
Status: Recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 7, 2021

End Date

July 6, 2030

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Aarhus

Responsible Party

Sponsor

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
•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.

Outcomes

Primary Outcomes

Local control

Time Frame: 12 months

MRI

Secondary Outcomes

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