None listed
Conditions
Brief summary
This pilot study will determine the safety and efficacy of a risk adapted hypofractionated (shortened course) of radiotherapy for treatment of elderly and/or fragile patients with Merkel cell carcinoma. Who is it for? You may be eligible to join this study if you are aged 60 years or above, have been diagnosed with Merkel cell carcinoma, are fragile and deemed unfit for a long course of radiotherapy or radio-/chemotherapy. Study details: Participants in this study will be included in either one of two groups according to their performance status. Participants with intermediate performance status will receive 46Gy - 52.5Gy in 20 fractions over 4 weeks, whilst participants with poor performance status will receive 33Gy in 6 fractions over 3 weeks. Patients may be treated with 3-D conformal RT, IMRT, Tomotherapy, VMAT, electron or kV / orthovolt radiotherapy at the discretion of their treating physician. Participants will be followed-up for up to 36 months post-treatment, in order to determine time to loco-regional progression, toxicity, survival rates and quality of life.
Interventions
Hypofractionated (shortened course) radiotherapy.
All patients will be treated with one of two hypofractionated radiotherapy schedules. The treating physician determines which schedule will be used.
Intermediate performance status patients will be treated to a dose of 46Gy in 20 fractions with gross disease boosted to 52.5Gy in 20 fractions (4 week total treatment time) with simultaneous integrated boost (SIB).
Poor performance status patients will be treated to a dose of 33Gy in 6 fractions ov
Hypofractionated (shortened course) radiotherapy. All patients will be treated with one of two hypofractionated radiotherapy schedules. The treating physician determines which schedule will be used. Intermediate performance status patients will be treated to a dose of 46Gy in 20 fractions with gross disease boosted to 52.5Gy in 20 fractions (4 week total treatment time) with simultaneous integrated boost (SIB). Poor performance status patients will be treated to a dose of 33Gy in 6 fractions over three weeks (treatments on Mon & Thurs or Tues & Fri). Patients may be treated with 3-D conformal RT, IMRT, Tomotherapy, VMAT, electron or kV / orthovolt radiotherapy.
Sponsors
Chris O'Brien Lifehouse
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
60 years or older, fragile, unfit for long course radiotherapy or radio-/chemotherapy. Histological diagnosis of Merkel Cell Cancer.
Exclusion criteria
Patients younger than 60 years Patients unable to give consent Patients who have previously had radiotherapy to the area of concern
Outcome results
None listed