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Clinical Trials/ACTRN12615001061527
ACTRN12615001061527
Withdrawn
Phase 3

A Randomised Controlled Pilot Study to Assess the Efficacy of Photodynamic Therapy vs. Radiotherapy for the Control of Basal Cell Carcinoma and Bowen's Disease.

St Vincent's Hospital, Sydney0 sites100 target enrollmentOctober 12, 2015
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
St Vincent's Hospital, Sydney
Enrollment
100
Status
Withdrawn
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 12, 2015
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
St Vincent's Hospital, Sydney

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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