The SHiP-Rt Study aims to investigate the safety and efficacy of reducing the number of RT fractions and RT duration, compared to the current standard of care (36Gy in 12 fractions over 16 days), by using shortened hypofractionated accelerated palliative radiotherapy (30Gy in 6 alternate-day fractions), aided by contemporary RT planning, verification, and delivery techniques.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Radiotherapy using 30Gy in 6 fractions (alternate days) over 12 days.
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire, United Kingdom
University Hospitals Coventry and Warwickshire
Coventry, Warwickshire, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, United Kingdom
The Shrewsbury and Telford Hospital NHS Trust
Shrewsbury, West Midlands, United Kingdom
Successful completion of treatment without reporting grade 3-4 oesophagitis, within 4 weeks of completing RT, using CTCAE v4.03.
Time frame: 4 weeks of completing RT
Toxicity if proposd hypofractionated high dose palliative RT using CTCAE v4.03
Time frame: 12 months
Patient reported outcome measures (PROMS) using Quality-of Life Questionnaires (QLQ-C30 & QLQ-LC13)
Time frame: 12 months
Disease response and progression
Time frame: 12 months
Cost-savings calculations to compare the proposed treatment regime to the standard of care.
Time frame: 12 months
Number of participants offered to participate in the study vs how many consent vs how many complete treatment
Time frame: 12 months
Time to start systemic therapy from recruitment.
Time frame: 12 months
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