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A Comparison of Intra-operative Radiotherapy Boost With External Beam Radiotherapy Boost in Early Breast Cancer.

NCT ID: NCT01792726

Last Updated: 2019-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1796 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2022-04-30

Brief Summary

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TARGIT-Boost is an international randomised clinical trial designed to test the hypothesis that the tumour bed boost delivered as a single dose of targeted intraoperative radiotherapy (TARGIT-B) is superior to the conventional course of external beam radiotherapy boost (EBRT-Boost), especially in women with high risk of local recurrence. It is a pragmatic trial in which each participating centre can use the local predefined inclusion/exclusion criteria for entry into the trial. Only centres with access to the Intrabeam® (Carl Zeiss) are eligible to enter patients into the trial.

Eligible patients are those with a higher risk of local recurrence after breast conserving surgery.

After giving consent patients are randomised to either TARGIT Boost or EBRT Boost. All patients will receive whole breast EBRT. They may receive any other adjuvant treatments as deemed necessary. The protocol recommends that patients be followed at six monthly intervals for three years and then annually.

The primary endpoint is ipsilateral breast recurrence rate. Secondary endpoints are relapse-free survival, site of recurrence, overall survival (breast-cancer specific and non-breast cancer deaths) patient satisfaction and quality of life.

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Detailed Description

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DESIGN: A pragmatic multi-centre randomised clinical trial to test whether TARGeted Intraoperative radioTherapy as a tumour bed Boost (TARGIT-B) is superior in terms of local relapse within the treated breast compared with standard post-operative external beam radiotherapy boost in women undergoing breast conserving therapy who have a higher risk of local recurrence. Patients can be entered before the primary surgery or in a smaller proportion of cases, post-pathology. SETTING: Specialist breast units in UK, USA, Canada, Australia and Europe; 31 centres currently recruiting in the TARGIT-A trial and several are ready to join. TARGET POPULATION: Breast cancer patients suitable for breast conserving surgery, but with a high risk of local recurrence. Details of inclusion and exclusion are given in part 2. Briefly the patients should be either younger than 45 or if older, need to have certain pathological features that confer a high risk of local recurrence of breast cancer. HEALTH TECHNOLOGIES BEING ASSESSED. The TARGIT Technique: The Intrabeam® (Carl Zeiss, FDA approved and CE marked) is a miniature electron beam-driven source which provides a point source of low energy X-rays (50kV maximum) at the tip of a 3.2mm diameter tube. The radiation source is inserted into the tumour bed immediately after excision of the tumour and switched on for 20-35 minutes to provide intra-operative radiotherapy accurately targeted to the tissues that are at highest risk of local recurrence. The physics, dosimetry and early clinical applications of this soft x-ray device have been well studied. For use in the breast, the technique was first developed and piloted at University College London. The radiation source is surrounded by a spherical applicator, specially designed (and available in various sizes) to produce a uniform field of radiation at its surface, enabling delivery of an accurately calculated dose to a prescribed depth. It is inserted in the tumour bed and apposed to it with surgical sutures and/or other means. As the x-rays rapidly attenuate the dose to more distant tissues is reduced; this also allows it to be used in standard operating theatres. 20 Gy is delivered to the tumour bed surface in 20-35 minutes, after which the radiation is switched off, the applicator removed, and the wound closed in the normal way. This simple technique has potentially several advantages over convential external beam radiotherapy, interstitial implantation of radioactive wires or conformal external beam radiotherapy. The first pilot of twenty-five cases was at performed at UCL using TARGIT technique as a replacement for the boost dose of radiotherapy; full dose external beam treatment was subsequently given. The phase II study of 300 patients was published and recently updated with long term data along with favourable toxicity and cosmetic outcome results of individual cohorts. A mathematical model of TARGIT developed recently (funded by Cancer Research UK) suggests that it could be superior to conventional radiotherapy. Translational research has found that TARGIT impairs the surgical-trauma-stimulated proliferation and invasiveness of breast cancer cells. This effect of radiotherapy may act synergistically with its tumouricidal effect yielding a superior result. MEASUREMENT OF COST AND OUTCOME: Patient assessments will be clinical examination (6 monthly x 3 years then yearly x 10 years) and mammography (yearly). with ulstrasound (if needed) . Primary outcome: histologically/cytologically proven local recurrence. Secondary: site of relapse in the breast, overall survival, local toxicity (RTOG and LENT SOMA criteria), cosmesis, quality of life, patient satisfaction and health economics. The cost and cost-effectiveness of TARGIT versus EBRT, both as boost, will be calculated from a NHS and personal social services (PSS) perspective. Costs directly incurred by patients will also be assesed, since EBRT as a boost is likely to impose additional time and travel expense to patients and families.

Conditions

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Early Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TARGIT

The experimental policy is to give targeted intra-operative radiotherapy (TARGIT-Boost) in a single dose to substitute for the usual boost dose, in addition to whole breast external beam radiotherapy delivered according to local treatment guidelines.

Group Type EXPERIMENTAL

Boost to the tumour bed

Intervention Type RADIATION

Boost to the tumour bed, with whole breast EBRT delivered according to local policy.

External beam radiotherapy boost

The conventional policy is to receive radiation boost to the tumour bed delivered by external beam radiotherapy (EBRT) in addition to whole breast external beam radiotherapy delivered according to local treatment guidelines.

Group Type ACTIVE_COMPARATOR

Boost to the tumour bed

Intervention Type RADIATION

Boost to the tumour bed, with whole breast EBRT delivered according to local policy.

Interventions

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Boost to the tumour bed

Boost to the tumour bed, with whole breast EBRT delivered according to local policy.

Intervention Type RADIATION

Other Intervention Names

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Radiotherapy boost

Eligibility Criteria

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Inclusion Criteria

At least one of these criteria must be satisfied:

1. Less than 46 years of age
2. More than 45 years of age, but with one of the following poor prognostic factors:

1. lymphovascular invasion
2. gross nodal involvement (not micrometastasis)
3. more than one tumour in the breast but still suitable for breast conserving surgery through a single specimen
3. More than 45 years of age, but with at least two of the following poor prognostic factors

1. ER and/or PgR negative
2. Grade 3 histology
3. Positive margins at first excision
4. Those patients with large tumours which have responded to neo-adjuvant chemo- or hormone therapy in an attempt to shrink the tumour and are suitable for breast conserving surgery as a result.
5. Lobular carcinoma or Extensive Intraductal Component (EIC)
6. A list (one to many) of high risk factors are present (as predefined in the policy document) that give a high risk of local recurrence.
7. Patients with either HER2 positive or HER2 negative can be included.

Exclusion Criteria

1. Bilateral breast cancer at the time of diagnosis.
2. Patients with any severe concomitant disease that may limit their life expectancy
3. Previous history of malignant disease does not preclude entry if the expectation of relapse-free survival at 10 years is 90% or greater (e.g., non-melanoma skin cancer, CIN, etc).
4. No more than 30 days can have elapsed between last breast cancer surgery (not axillary) and randomisation for patients in the post-pathology stratification unless part of a specific clinical trial that addresses the question of timing or tumour bed can be reliably identified, e.g., by ultrasound.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jayant S Vaidya, MBBS FRCS

Role: PRINCIPAL_INVESTIGATOR

University College, London

Locations

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Helen Rey Breast Cancer Research Foundation

Los Angeles, California, United States

Site Status RECRUITING

Memorial Health University Medical Center

Savannah, Georgia, United States

Site Status ACTIVE_NOT_RECRUITING

Beaumont Health - Royal Oak

Detroit, Michigan, United States

Site Status RECRUITING

Lakeland Regional Health System

Saint Joseph, Michigan, United States

Site Status RECRUITING

Ashikari Breast Center

Dobbs Ferry, New York, United States

Site Status RECRUITING

Cleveland Clinic

Cleveland, Ohio, United States

Site Status RECRUITING

West Virginia University

Morgantown, West Virginia, United States

Site Status RECRUITING

Aurora Breast Center

Green Bay, Wisconsin, United States

Site Status RECRUITING

Beijing Cancer Hospital

Beijing, , China

Site Status RECRUITING

Institut Bergonié

Bordeaux, , France

Site Status RECRUITING

Centre François Baclesse

Caen, , France

Site Status RECRUITING

Centre Georges François Leclerc

Dijon, , France

Site Status RECRUITING

Centre Léon Bérard

Lyon, , France

Site Status RECRUITING

Hôpital Nord

Marseille, , France

Site Status RECRUITING

Institut de Cancerologie de l'Ouest site René Gauducheau

Nantes, , France

Site Status RECRUITING

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, , France

Site Status RECRUITING

Centro Di Riferimento Oncologico Di Aviano

Aviano, , Italy

Site Status RECRUITING

Istituto Oncologico Veneto

Padua, , Italy

Site Status RECRUITING

University Malaya Medical Centre

Kuala Lumpur, , Malaysia

Site Status RECRUITING

University of Dammam

Dammam, , Saudi Arabia

Site Status RECRUITING

Netcare Milpark Hospital

Johannesburg, , South Africa

Site Status RECRUITING

Gangnam Severance Hospital

Seoul, , South Korea

Site Status RECRUITING

Institut Català d'Oncologia

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitario Dr Negrín

Las Palmas de Gran Canaria, , Spain

Site Status RECRUITING

Brust-Zentrum Onkologie

Zurich, , Switzerland

Site Status RECRUITING

Queen Sirikit Cantre for Breast Cancer

Bangkok, , Thailand

Site Status RECRUITING

Princess Alexandra Hospital NHS Trust

Harlow, , United Kingdom

Site Status RECRUITING

Whittington Hospital

London, , United Kingdom

Site Status RECRUITING

Royal Free London NHS Trust

London, , United Kingdom

Site Status RECRUITING

Guy's Hospital

London, , United Kingdom

Site Status RECRUITING

Hospital of St John and St Elizabeth

London, , United Kingdom

Site Status RECRUITING

Princess Grace Hospital

London, , United Kingdom

Site Status ACTIVE_NOT_RECRUITING

The Great Western Hospital

Swindon, , United Kingdom

Site Status RECRUITING

Hampshire Hospitals NHS Foundation Trust

Winchester, , United Kingdom

Site Status RECRUITING

Countries

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United States China France Italy Malaysia Saudi Arabia South Africa South Korea Spain Switzerland Thailand United Kingdom

Central Contacts

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Norman R Williams, PhD

Role: CONTACT

[email protected]
+44 (0)20 7679 9280

Nick Roberts

Role: CONTACT

[email protected]
+44 (0)20 7679 9280

Facility Contacts

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Alexandra Banks

Role: primary

[email protected]

Blerina Pople

Role: primary

[email protected]

Pamela Stephenson

Role: primary

[email protected]

Pond Kelemen, MD

Role: primary

Courtney Yanda

Role: primary

[email protected]

Cortney Montgomery

Role: primary

[email protected]

Corinne Zipperer, RN

Role: primary

[email protected]

Xinguang Wang

Role: primary

Boly Ann

Role: primary

[email protected]

Didier Cowen, MD

Role: primary

Magali Le Blanc, MD

Role: primary

Francoise Izar, MD

Role: primary

Samuele Massarut, MD

Role: primary

Fabiana Gregucci

Role: primary

Zarinah Abdul Rahman

Role: primary

[email protected]

Kyara Bergstrom

Role: primary

Sung Gwe Ahn

Role: primary

Montse Ventura

Role: primary

[email protected]

Bärbel Papassotiropoulos

Role: primary

Sikrit Denariyakoon

Role: primary

Jayant S Vaidya, MBBS FRCS

Role: primary

[email protected]

Mo Keshtgar, MB BS

Role: primary

[email protected]

Sweta Sethi

Role: primary

Mo Keshtgar, MB BS

Role: primary

[email protected]

Elizabeth Happle

Role: primary

[email protected]

Other Identifiers

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NHS NIHR HTA

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

TARGIT Boost

Identifier Type: -

Identifier Source: org_study_id

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