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

Study Overview
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Brief Summary
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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.

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

Conditions
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Anal Cancer, Recurrent Anal Cancer

Intervention / Treatment
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* Radiation: Pencil beam proton therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Doseescalated pencil beam proton therapy<br>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. | Radiation: Pencil beam proton therapy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local control | MRI | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local re-recurrence |  | 6 and 24 months | 
| Progression free survival |  | 3-5 year FU | 
| Overall survival |  | 3-5 year FU | 
| Pathological evaluation of R0, R1 or R2 resection |  | 6 months | 
| Toxicity | evaluated by NCI-CTCAE v. 5.0 | up to 6 weeks, 1 year, 3 year | 
| Quality of life assessment | EORTC QLQ-c30 | up to 6 weeks, 1 year, 3 year | 
| Quality of life assessment | QLQ-CR29 | up to 6 weeks, 1 year, 3 year | 
| Quality of life assessment | QLQ-ANL27 | up to 6 weeks, 1 year, 3 year | 
| Quality of life assessment | LARS score | up to 6 weeks, 1 year, 3 year | 
| Translational research | cfDNA | baseline, end of therapy, 1 year | 
| 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 | Clavien-Dindo | 30-day | 
| To investigate 6-month surgical site morbidity |  | 6 months |