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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
Sponsor:
Information provided by (Responsible Party):
University College, London

Brief Summary:
This is a prospectively registered database of patients with early breast cancer who will be treated with radiotherapy during surgery. More than 2000 women have already received this treatment in clinical trials. This study will monitor the health status of women who receive this treatment outside of a clinical trial, especially those who might not have been eligible for the original clinical trials. The aim is to confirm the long-term effectiveness and safety of the technique.

Condition or disease
Early-Stage Breast Carcinoma

Detailed Description:

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The target population is very wide, reflecting the pragmatic nature of this study.

There will be few inclusion and exclusion criteria. Basically, any person aged over 18 with early breast cancer suitable for breast conserving surgery will be eligible. More specific entry criteria for those aged 45 or less will be defined by a participating institution's multidisciplinary team. Experience to date has indicated that there are many patients who are deemed unsuitable for a course of external beam radiotherapy whose only option is therefore mastectomy; such situations can be difficult to define in advance, and should be decided on a case-by-case basis.

Criteria

Inclusion Criteria:

  • Recommended treatment by MDT
  • Consent has been obtained to have patient data to be collected

Exclusion Criteria:

  • Pregnancy (females who have a positive pregnancy test prior to surgery)
  • Under 18 years of age

Information from the National Library of Medicine

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


Contacts
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Contact: Nick J Roberts SITU.TARGITR@ucl.ac.uk
Contact: Norman Williams, PhD SITU.TARGITR@ucl.ac.uk

Locations
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United Kingdom
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         
Sponsors and Collaborators
University College, London
Investigators
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Principal Investigator: Jayant S Vaidya UCL

Additional Information:

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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02947425     History of Changes
Other Study ID Numbers: TARGIT R
ISRCTN91179875 ( Other Identifier: ISRCTN registry )
14/LO/1452 ( Other Identifier: UK NRES )
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All requests for data sharing will adhere to the UCL Surgical & Interventional Trials Unit (SITU) data sharing agreement policy. UCL Medical School is supportive of data sharing and will endeavour to assist in requests for data sharing. These data will be held at UCL on secure servers and will not be released to any third parties until the final study report has been published. All requests for access to the data will be formally requested through the use of a SITU data request form which will state the purpose, analysis and publication plans together with the named collaborators. All requests are dealt with on a case by case basis. All requests will be logged and those successful will have a data transfer agreement which will specify appropriate acknowledgement of the Royal Free Hospital, the sponsor, and funders.

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases