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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
55
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
Danish Centre for Particle Therapy
Aarhus N, Aarhus, Denmark
RECRUITINGLocal control
MRI
Time frame: 12 months
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
evaluated by NCI-CTCAE v. 5.0
Time frame: up to 6 weeks, 1 year, 3 year
Quality of life assessment
EORTC QLQ-c30
Time frame: up to 6 weeks, 1 year, 3 year
Quality of life assessment
QLQ-CR29
Time frame: up to 6 weeks, 1 year, 3 year
Quality of life assessment
QLQ-ANL27
Time frame: up to 6 weeks, 1 year, 3 year
Quality of life assessment
LARS score
Time frame: up to 6 weeks, 1 year, 3 year
Translational research
cfDNA
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Clavien-Dindo
Time frame: 30-day
To investigate 6-month surgical site morbidity
Time frame: 6 months