Pencil Beam Proton Therapy for Recurrences in Anal Cancer Patients Previously Treated With Radiotherapy (DACG 5)
ReRad III
ReRad III. Pencil Beam Proton Therapy for Recurrences in Anal Cancer Patients Previously Treated With Radiotherapy
1 other identifier
interventional
55
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2021
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 7, 2021
CompletedFirst Submitted
Initial submission to the registry
July 8, 2021
CompletedFirst Posted
Study publicly available on registry
September 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 6, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 6, 2030
September 24, 2021
July 1, 2021
6 years
July 8, 2021
September 14, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Local control
MRI
12 months
Secondary Outcomes (13)
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
up to 6 weeks, 1 year, 3 year
- +8 more secondary outcomes
Study Arms (1)
Doseescalated pencil beam proton therapy
EXPERIMENTALNeo-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.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Danish Centre for Particle Therapy
Aarhus N, Aarhus, 8200, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2021
First Posted
September 24, 2021
Study Start
July 7, 2021
Primary Completion (Estimated)
July 6, 2027
Study Completion (Estimated)
July 6, 2030
Last Updated
September 24, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share