Clinical Trial: Study of Electronic Brachytherapy for Cutaneous Basal Cell Carcinoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Study of Electronic Brachytherapy for Cutaneous Basal Cell Carcinoma

Brief Summary: Electronic brachytherapy (EBT) offers an isotope-free radiation therapy modality for the treatment of specific skin lesions, especially non-melanoma skin cancers (NMSC). Within the treatment of NMSC, surgical removal of the lesion is currently the treatment of choice for the majority of cases. However in an estimated 10-15% of NMSC patients, surgery might not be the best treatment option. Location of the tumour in cosmetically sensitive areas, patient comorbidities, old age, use of anti-coagulation etc. might all be reasons to select radiotherapy as first choice of treatment. The objective of ths study will be to determine histologically confirmed clinical efficacy, safety, and usability of Electronic Brachytherapy, an innovative treatment for Basal Cell Carcinoma (BCC).

Detailed Summary:

  • Rationale: Electronic brachytherapy (EBT) offers an isotope-free radiation therapy modality for the treatment of specific skin lesions, especially non-melanoma skin cancers (NMSC). Within the treatment of NMSC, surgical removal of the lesion is currently the treatment of choice for the majority of cases. However in an estimated 10-15% of NMSC patients, surgery might not be the best treatment option. Location of the tumour in cosmetically sensitive areas, patient comorbidities, old age, use of anti-coagulation etc. might all be reasons to select radiotherapy as first choice of treatment.
  • Objective: To determine histologically confirmed clinical efficacy, safety, and usability of Electronic Brachytherapy, an innovative treatment for Basal Cell Carcinoma (BCC).
  • Study design: Prospective, out-patient based, single centre, single treatment modality
  • Study population: 40 patients, >18 years old, having at least 1 BCC. Intervention: BCC will be treated with EBT, using low-energy X-rays. Area of the lesion will be evaluated for tumour presence and size before, during and at 2 weeks, 6 weeks and 3 months after treatment. If the patient has more than one BCC, all of them will be treated with Electronic Brachytherapy but only the largest one will be analysed in the study.
  • Main study parameters/endpoints: Local control of BCC.
  • Secondary parameters: Acute skin toxicity, skin cosmesis, and care giver satisfaction, and patient satisfaction.
  • Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will be exposed to low-energy X-rays. Required site-visits are: 1 pretreatment visits (intake/informed consent and biopsy), 6 treatment visits over
    Sponsor: Instituto de Investigacion Sanitaria La Fe

    Current Primary Outcome:

    • Clinical Response of Electronic Brachytherapy [ Time Frame: 2 weeks after treatment ]
      Response criteria: Complete response (disappearance of tumor), partial response persistence with tumor size reduction), no response (no change in tumor size), tumor progression (increase in tumor size).
    • Clinical Response of Electronic Brachytherapy [ Time Frame: 6 weeks after treatment ]
      Response criteria: Complete response (disappearance of tumor), partial response persistence with tumor size reduction), no response (no change in tumor size), tumor progression (increase in tumor size).
    • Clinical Response of Electronic Brachytherapy [ Time Frame: 3 months after treatment ]
      Response criteria: Complete response (disappearance of tumor), partial response persistence with tumor size reduction), no response (no change in tumor size), tumor progression (increase in tumor size).
    • Clinical Response of Electronic Brachytherapy [ Time Frame: 6 months after treatment ]
      Response criteria: Complete response (disappearance of tumor), partial response persistence with tumor size reduction), no response (no change in tumor size), tumor progression (increase in tumor size).
    • Clinical Response of Electronic Brachytherapy [ Time Frame: 12 months after treatment ]
      Response criteria: Complete response (disappearance of tumor), partial response persistence with tumor size reduction), no response (no change in tumor size), tumor progression (increase in tumor size

      Original Primary Outcome: Same as current

      Current Secondary Outcome:

      • Patient quality of life [ Time Frame: Before treatment and at 3 months post treatment. ]
        Patient quality of life before and after treatment with Esteya Electronic brachytherapy will be measured using the validated Skindex 16 questionnaire. Patient quality of life will be measured before treatment and at 3 months post treatment.
      • Rate of grade ≥3-4 adverse events [ Time Frame: 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months after treatment. ]
        The study will use the EORTC-RTOG and Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for assessing toxicity related to brachytherapy. Grade 4 or higher adverse events will be reported, with the exception of grade 4 radiation dermatitis. Grade 5 radiation dermatitis will be reported.
      • Caregiver experience (questionnaire) [ Time Frame: 3 weeks ]
        User experience with the Esteya electronic brachytherapy device will be measured using the USE Questionnaire (http://hcibib.org/perlman/question.cgi?form=USE). All users of the device will be asked to fill in one questionnaire after their last use of the treatment device. Only one questionnaire will be filled in per user.


      Original Secondary Outcome: Same as current

      Information By: Instituto de Investigacion Sanitaria La Fe

      Dates:
      Date Received: October 13, 2016
      Date Started: July 2013
      Date Completion:
      Last Updated: October 17, 2016
      Last Verified: October 2016