TARGeted Intraoperative radioTherapy (TARGIT) Registry Database (TARGIT R)
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|ClinicalTrials.gov Identifier: NCT02947425|
Recruitment Status : Recruiting
First Posted : October 27, 2016
Last Update Posted : July 11, 2018
|Condition or disease|
|Early-Stage Breast Carcinoma|
Registration of patients selected for this treatment; collecting data regarding safety and toxicity on patients who have had treatment with TARGIT.
Outcomes will be measured over short and long terms. Outcome measures will include effectiveness and safety, assessed in various cohorts of patients. Core outcomes will be used for effectiveness. In addition, true recurrence (basically, ipsilateral breast tumor recurrence at the same site as the original primary) will be used as defined by Recht. Safety outcomes will be based on Common Toxicity Criteria.
Budget impact analysis of IORT in subgroups of patients will be assessed. This amounts to using cost data to calculate the mean incremental (or extra) cost per person treated using intraoperative radiotherapy (IORT) versus external beam radiotherapy (EBRT) and mastectomies (where IORT could have been given instead) and then multiplying this by the total patients eligible nationally for IORT, to calculate the total expected budget impact on the NHS if IORT in these subgroups was rolled out nationally.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||2000 participants|
|Target Follow-Up Duration:||10 Years|
|Official Title:||TARGIT R: TARGeted Intraoperative radioTherapy (TARGIT) Registry Database|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||July 2022|
- Local tumour control (defined as no recurrent tumour in the ipsilateral breast) [ Time Frame: Five years ]Confirmation that the TARGIT technique results in an acceptably low rate of local recurrence when given outside of a randomised controlled trial.
- Adverse events related to the primary treatment of the breast cancer. [ Time Frame: Five years ]Confirmation that the TARGIT technique results in an acceptably low rate of safety events assessed by CTCAE v4.0 when given outside of a randomised controlled trial.
- Cost effectiveness [ Time Frame: Five years ]Confirmation that the TARGIT technique is cost-effective as assessed by both health related quality of life (EQ5D) and cost data.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02947425
|Contact: Nick J Roberts||SITU.TARGITR@ucl.ac.uk|
|Contact: Norman Williams, PhD||SITU.TARGITR@ucl.ac.uk|
|Royal Free Hospital||Recruiting|
|London, United Kingdom|
|Contact: Norman Williams, PhD SITU.TARGITR@ucl.ac.uk|
|Principal Investigator: Sarah Needleman|
|The London Clinic||Recruiting|
|London, United Kingdom|
|Contact: Alistair Gifford-Moore|
|Principal Investigator: Gerald Gui|
|Royal Hampshire County Hospital||Not yet recruiting|
|Winchester, United Kingdom|
|Contact: Siobhan <> Laws, FRCS Siobhan.Laws@hhft.nhs.uk|
|Principal Investigator: Dick Rainsbury, FRCS|
|Principal Investigator:||Jayant S Vaidya||UCL|