A Pilot Randomised Controlled Pilot Study to Assess the Efficacy of Photodynamic Therapy vs. Radiotherapy for Superficial Skin Cancer.

Phase 3

Withdrawn

• Conditions: Basal Cell Carcinoma; Bowen's Disease; Cancer - Non melanoma skin cancer

• Registration Number: ACTRN12615001061527
• Lead Sponsor: St Vincent's Hospital, Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1 Biopsy-proven superficial BCC or Bowen’s disease.
2 De novo lesions; i.e. lesions previously untreated.
3 Lesion able to be treated by PDT or RT.
4 Lesion originally at least 10mm in maximum dimension(this is to facilitate a single 3mm punch biopsy needed for diagnosis and for an optional translation study based on immunohistochemical staining of the diagnostic biopsy).
5 18 years or older.
6 Patient is not suitable for surgery either because surgery is too great a burden, the patient is not capable of having surgery (usually due to comorbidity) or has refused surgery.
7 Immunosuppressed patients to be included (HIV, Transplant, Auto immune being actively treated (i.e. with chemotherapy (CTX) or steroid dose over 7mg prednisolone equivalent daily) with stratification.
8 Life expectancy of at least 2 years.

Exclusion Criteria

1 Lesions unsuitable for PDT or radiotherapy: More infiltrative skin cancers (including nodular, micronodular, infiltrative, morphoeic BCC or infiltrating SCC); Perineural invasion; Subungual lesions; Perioccular lesions unable to be treated by PDT or RT; Larger than PDT field (8x18cm); Pigmented BCC; Genital and perianal lesions
2 Aged under 18 years
3 Unable to attend treatment for practical reasons
4 Porphyria, SLE
5 Pregnancy, lactation
6 Unable to have RT – e.g. Gorlins, XP.
7 Photosensitive disorder to visible light spectrum
8 Hypersensitivity to the Metvix cream
9 Previous treatment to index lesion

Study & Design

• Study Type: Interventional
• Study Design: Not specified