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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05055635
Other study ID # DCPT070721
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date July 7, 2021
Est. completion date July 6, 2030

Study information

Verified date July 2021
Source University of Aarhus
Contact Camilla Kronborg, MD, PhD
Phone +45 78 45 00 00
Email camkro@rm.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 55
Est. completion date July 6, 2030
Est. primary completion date July 6, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

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

Locations

Country Name City State
Denmark Danish Centre for Particle Therapy Aarhus N Aarhus

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Local control MRI 12 months
Secondary Local re-recurrence 6 and 24 months
Secondary Progression free survival 3-5 year FU
Secondary Overall survival 3-5 year FU
Secondary Pathological evaluation of R0, R1 or R2 resection 6 months
Secondary Toxicity evaluated by NCI-CTCAE v. 5.0 up to 6 weeks, 1 year, 3 year
Secondary Quality of life assessment EORTC QLQ-c30 up to 6 weeks, 1 year, 3 year
Secondary Quality of life assessment QLQ-CR29 up to 6 weeks, 1 year, 3 year
Secondary Quality of life assessment QLQ-ANL27 up to 6 weeks, 1 year, 3 year
Secondary Quality of life assessment LARS score up to 6 weeks, 1 year, 3 year
Secondary Translational research cfDNA baseline, end of therapy, 1 year
Secondary Summed radiotherapy dose volume to organs at risk and correlation to toxicities up to 6 weeks, 1 year, 3 year
Secondary To investigate 30-day surgical overall morbidity Clavien-Dindo 30-day
Secondary To investigate 6-month surgical site morbidity 6 months
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