ClinTrial Refer

Trial Acronym
GENTLER

Registration Number
ACTRN12620000618954

Scientific Title
GenesisCare Epithelial Neoplasia Trial using Lighter dose Extensive field Radiotherapy

The purpose of this trial is to see if a reduced radiotherapy can deliver equivalent treatment response to full dose radiotherapy for patients with skin cancer.

Who is it for?
You may be eligible for this study if you are aged 50 or older and have non-melanoma skin cancer.

Study details
Participants in this group will receive one of two treatments.  This is determined by patient preference  and medical officer recommendation.  Both groups will have the reduced radiotherapy dose for 5 weeks, either as five doses per week with a week between treatment weeks; or as 3 doses per week for 5 weeks. Both groups will receive the same dose.

The purpose of this trial is to see if a reduced radiotherapy can deliver equivalent treatment response to full dose radiotherapy for patients with skin cancer.

A total of 100 participants will be recruited with the study across selected GenesisCare Sites within Australia.  It is anticipated that it will take 36 months to complete the accrual of 100 participants. All participants will be followed for another 12 months after the end of accrual, giving the trial a total duration of 48 months (4 years).

1.	Be aged 50 years or greater;

2.	Have ESFC greater than 50 cm2;

3.	Provide written informed consent; and

4.	Fulfil at least two of the following three criteria (a, b, c):
a.	Karnofsky performance score of less than or equal to 70;
b.	Be unable to complete a fully fractionated, long-course of treatment due to a comorbidity or the requirement for nursing home care;
c.	Be aged greater than or equal to 70 years 

5.	Charlson Comorbidity Score  greater than or equal to 5

6.  Willing to use adequate contraception measures (both in vivo and in vitro) during and for six months after radiation treatment for participants who will engage in the conception of a child

1.	Received local therapy within the last 4 weeks.  This includes excision, cryotherapy, photo-dynamic therapy, radiotherapy or topical agents including 5FU, imiquimod ingenol mebutatte.

2.	Have a clinically or biopsy-proven invasive skin malignancy within the treatment field to be treated which has either been untreated, or incompletely excised within the last 6 months

3.	Currently receiving systemic chemotherapy or treatment with new targeted drugs (e.g. immunotherapy, tyrosine kinase inhibitors or BRAF inhibitors);

4.	Are concurrently using radio sensitising drugs for medical comorbidities (e.g. methotrexate for rheumatoid arthritis, hydroxyurea etc);

5.	For patients who are having lower limbs treated and have any of the following:
•	Chronic lymphoedema with pitting oedema, peripheral vascular disease in the form of intermittent claudication or critical ischemia
•	Chronic leg ulcer within the proposed treatment field
•	Relapsing cellulitis 

6.	Have received prior radiotherapy to the same treatment site or

7.     Any other medical condition as defined by the investigator which significantly impacts the patient’s involvement and suitability in this study

Trial Location Name

Address

Status

Genesiscare Fiona Stanley Hospital Radiation Oncology Centre

GenesisCare, Murdoch Drive, Murdoch WA, Australia

Closed

Primary Contact : Trial Coordinator, CWA-ClinicalTrialsCoordinators@genesiscare.com , +618 6152 5273

GenesisCare

Website URL

Link Name

Link URL

ANZCTR

http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ACTRN12620000618954p

Secondary IDs
N/A

Study Type
Interventional

Intervention Code
Treatment - Other

Phase
Not Applicable

Minimum Age
50

Maximum Age
100

Date Registered
03/08/2020

Date Closed
N/A

Status
Closed

Enrolment Type
By Specialist and/or Surgeon Referral

Mutation Status and Biomarker
Any or not stated

Is it a Cohort Trial?
No

Is this a Tele-Trial?
No

Can healthy volunteer participate?
No

Discipline

Health Condition

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