The GENTLER Trial: GenesisCare Epithelial Neoplasia Trial using Lighter dose Extensive field Radiotherapy

Not Applicable

• Conditions: Skin cancer; Cancer - Non melanoma skin cancer

• Registration Number: ACTRN12620000618954
• Lead Sponsor: GenesisCare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-27
• Last Update Posted: 3 April 2023

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified