A pilot study: Risk adapted hypofractionated radiotherapy in Merkel Cell Carcinoma of the elderly and/or the fragile patient.

Not Applicable

• Conditions: Merkel Cell Carcinoma; Cancer - Non melanoma skin cancer

• Registration Number: ACTRN12615000190505
• Lead Sponsor: Chris O'Brien Lifehouse

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-26
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to loco-regional progression as assessed by clinical follow-up<br><br><br>[4 monthly for two years<br>6 monthly for third year];Incidence of acute grade 3 and 4 toxicity (CTCAE version 4)[At baseline, weekly during RT, then one and two weeks after completion of RT.<br>Four monthly for two years<br>Six monthly for third year]

Secondary Outcome Measures

Name	Time	Method
Time to distant failure as assessed by clinical follow-up.<br><br><br>[4 monthly for two years<br>6 monthly for third year<br>];Overall survival as assessed by clinical follow-up.<br>[4 monthly for two years<br>6 monthly for third year<br>];Quality of life as assessed by FACIT-F trial outcome index<br><br>[At baseline and at 3, 4 and 7 weeks after RT commencement and at 12, 24, 36 months.]