Study design: A prospective phase II, non-randomized observational study of dose-escalated pencil beam proton therapy re-irradiation for pelvic recurrences from rectal cancer. Re-irradiation is either a part of neo-adjuvant treatment or as a definitive treatment strategy for un-resectable recurrences.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
65
Doseescalated pencil beam proton Therapy
Danish Centre for Particle Therapy
Aarhus, Denmark
RECRUITINGR0-resection
Neo-adjuvant treatment: Rate of pathological complete resection (R0)
Time frame: 5-6 years
1-year local control
Definitive treatment: Rate of 1-year local control rates evaluated by CT or MRI.
Time frame: 6-7 years
Local recurrence
Local re-recurrence determined by imaging 6, 12 and 24 month post treatment
Time frame: 6-8 years
Disease free survival
Disease free survival, defined as time from first day of treatment until first documented sign of disease or death from any course
Time frame: 10 years
Overall survival
Overall survival defined as time from first day of treatment to death from any cause
Time frame: 10 years
Toxicity
Toxicity evaluated by NCI-CTCAE v. 5.0 acute and chronic
Time frame: 5-7 years
Patient reported outcomes
Quality of life assessment by EORTC QLQ-c30, QLQ-CR29, supplementary EORTC items, and LARS score. Acute and chronic
Time frame: 5-7 year
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