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Trial registered on ANZCTR


Registration number
ACTRN12615000190505
Ethics application status
Not yet submitted
Date submitted
13/02/2015
Date registered
26/02/2015
Date last updated
8/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study: Risk adapted hypofractionated radiotherapy in Merkel Cell Carcinoma of the elderly and/or the fragile patient.
Scientific title
A pilot study: Risk adapted hypofractionated radiotherapy in Merkel Cell Carcinoma of the elderly and/or the fragile patient assessing safety/efficacy.
Secondary ID [1] 286170 0
None
Universal Trial Number (UTN)
Trial acronym
MP4-pilot study.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Merkel Cell Carcinoma 294186 0
Condition category
Condition code
Cancer 294511 294511 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 291174 0
Treatment: Other
Comparator / control treatment
Prospective study with one of two hypofractionated radiotherapy treatment options.
The results will be descriptively compared between both groups (dose comparison) and also will be described in the context of historical data (TROG 96.07 study, Publication Poulsen M et al, JCO 2003).
Control group
Dose comparison

Outcomes
Primary outcome [1] 294290 0
Time to loco-regional progression as assessed by clinical follow-up
Timepoint [1] 294290 0
4 monthly for two years
6 monthly for third year
Primary outcome [2] 294363 0
Incidence of acute grade 3 and 4 toxicity (CTCAE version 4)
Timepoint [2] 294363 0
At baseline, weekly during RT, then one and two weeks after completion of RT.
Four monthly for two years
Six monthly for third year
Secondary outcome [1] 312969 0
Time to distant failure as assessed by clinical follow-up.
Timepoint [1] 312969 0
4 monthly for two years
6 monthly for third year
Secondary outcome [2] 313101 0
Overall survival as assessed by clinical follow-up.
Timepoint [2] 313101 0
4 monthly for two years
6 monthly for third year
Secondary outcome [3] 313102 0
Quality of life as assessed by FACIT-F trial outcome index
Timepoint [3] 313102 0
At baseline and at 3, 4 and 7 weeks after RT commencement and at 12, 24, 36 months.

Eligibility
Key inclusion criteria
60 years or older, fragile, unfit for long course radiotherapy or radio-/chemotherapy. Histological diagnosis of Merkel Cell Cancer.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive statistics.
Time to loco-regional progression (TTLRP), time to distant failure (TTDF) and overall survival (OS) curves will be calculated using the Kaplan-Meier (K-M) method.
Incidences of grade 3 or 4 acute toxicity will be reported as the proportions of patients developing these conditions; 95% confidence intervals (CI) for the true incidences will be calculated.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 290740 0
Hospital
Name [1] 290740 0
Radiation Oncology
Chris O'Brien Lifehouse
Country [1] 290740 0
Australia
Primary sponsor type
Hospital
Name
Chris O'Brien Lifehouse
Address
119-143 Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 289426 0
None
Name [1] 289426 0
n/a
Address [1] 289426 0
n/a
Country [1] 289426 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 292372 0
Sydney Local Health District HREC - RPAH Zone
Ethics committee address [1] 292372 0
Research Development Office
RPAH Medical Centre
Suite 210A, 100 Carillon Avenue
Newtown NSW 2042
Ethics committee country [1] 292372 0
Australia
Date submitted for ethics approval [1] 292372 0
18/02/2015
Approval date [1] 292372 0
Ethics approval number [1] 292372 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54914 0
A/Prof George Hruby
Address 54914 0
Radiation Oncology
Chris O'Brien Lifehouse
119-143 Missenden Road
Camperdown NSW 2050
Country 54914 0
Australia
Phone 54914 0
+ 61 2 8514 0218
Fax 54914 0
Email 54914 0
[email protected]
Contact person for public queries
Name 54915 0
Diana Naehrig
Address 54915 0
Radiation Oncology
Chris O'Brien Lifehouse
119-143 Missenden Road
Camperdown NSW 2050
Country 54915 0
Australia
Phone 54915 0
+ 61 2 8514 0490
Fax 54915 0
Email 54915 0
[email protected]
Contact person for scientific queries
Name 54916 0
George Hruby
Address 54916 0
Radiation Oncology
Chris O'Brien Lifehouse
119-143 Missenden Road
Camperdown NSW 2050
Country 54916 0
Australia
Phone 54916 0
+ 61 2 8514 0218
Fax 54916 0
Email 54916 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.