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TARGIT-C(Consolidation) Prospective Phase IV Study of IORT in Patients With Small Breast Cancer (TARGIT-C)

This study is currently recruiting participants.
Verified October 2017 by Frederik Wenz, Universitätsmedizin Mannheim
Sponsor:
ClinicalTrials.gov Identifier:
NCT02290782
First Posted: November 14, 2014
Last Update Posted: October 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Frederik Wenz, Universitätsmedizin Mannheim
  Purpose

This prospective, multicentric single arm phase IV study is based on the protocol of the international TARGIT-A and TARGIT-E study.

Patients ≥ 50 years with small, low-risk breast cancer who are operated but not irradiated show local relapse rates around 6% after 5 years. With adjuvant whole breast radiotherapy (WBRT) the local relapse rate drops to under 1% after 5 years under Tamoxifen (4).

It has been demonstrated (6, 9, 10) that the efficacy of radiation of the tumor bed only in a selected group can be non-inferior to WBRT.

The TARGIT C study should confirm the efficacy of a single dose of intraoperative radiotherapy (IORT) in a well selected group of patients with small breast cancer and absence of risk factors. In presence of risk factors postoperative WBRT will be added to complete the radiotherapeutic treatment according to international guidelines.

Endpoints are the local relapse rate (within 2 cm of the tumor bed), ipsilateral relapse, cancer-specific and overall survival and contralateral breast cancer as well as documentation of quality of life and cosmetic outcome.

The expected local relapse rates are 0.825/1.375% after 3/5 years, respectively. Discontinuation of the trial is scheduled if rates of local relapse rates rise to 1.55/2.4/4% after 1/3/5 years. Power calculations result in 387 patients with a calculated dropout and loss to follow-up rate of 10%, an alpha of 0.05 and a beta of 0.10. There will be only a pre-pathology stratum.

It is a pragmatic trial in which each participating centre has the option to modify entry criteria and criteria for WBRT according to this core protocol after consultation with the steering committee and local ethics committee (e.g. size, free margins). Only centers with access to the Intrabeam® system (Carl Zeiss) can recruit patients into the trial.


Condition Intervention Phase
Breast Cancer Radiation: Intraoperative radiotherapy (IORT) Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
Single arm study: IORT +/- EBRT
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TARGIT-C(Consolidation) Prospective Phase IV Study of Intraoperative Radiotherapy (IORT) in Patients With Small Breast Cancer

Resource links provided by NLM:


Further study details as provided by Frederik Wenz, Universitätsmedizin Mannheim:

Primary Outcome Measures:
  • Local relapse [ Time Frame: 5 years ]
    Local relapse rate within 2 cm of the tumor bed


Secondary Outcome Measures:
  • Ipsi- or contralateral breast cancer [ Time Frame: 5 years ]
    Ipsi- or contralateral breast cancer

  • Survival [ Time Frame: 5 years ]
    cancer specific and overall survival

  • Toxicity (CTC, LENT SOMA) [ Time Frame: 5 years ]
    cosmetic outcome, acute and late toxicity measured by CTC Score and LENT SOMA scale

  • Quality of Life [ Time Frame: 5 years ]
    Quality of life measured by EORTC QLQ C30 and BR23


Estimated Enrollment: 387
Study Start Date: October 2014
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intraoperative radiotherapy (IORT)

IORT (20Gy) as intervention will be given during breast conserving surgery. If risk factors (Tumor > 3.5 cm, lobular cancer, resection margin < 2 mm*, L1, pN+ mulitfocal/multicentric, EIC, negative hormone receptors) are present, external beam radiotherapy will be added.

* In case of positive margins (<2 mm resection margin) a re-resection should be done

Radiation: Intraoperative radiotherapy (IORT)

The surgeon and radiation oncologist should choose the largest possible suitable applicator in order to ensure that the highest possible dose is delivered to the tumor bed tissue. A dose of 20 Gy at the surface of the applicator (in water) is prescribed by the radiation oncologist and delivered to the breast tissue. This takes approximately 20-50 minutes, depending on the size of the applicator.

To minimize radiation dependent side effects the skin-applicator surface distance should be more than 5 mm.


  Show Detailed Description

  Eligibility

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histologically verified invasive-ductal breast cancer
  • hormone receptor positive (if known)
  • cT1 or small cT2 (≤ 3.5 cm) cN0 cM0
  • ≥ 50 years of age
  • informed consent
  • compliance

Exclusion Criteria:

  • extensive intraductal component (EIC)
  • negative hormone receptor status
  • multifocality /-centricity (mammography, breast ultrasound)
  • lymph vessel invasion (L1)
  • clinical signs of distant metastases or clinically suspicious lymph nodes
  • other histology
  • < 50 years
  • missing informed consent or non-compliance
  • bilateral breast cancer at the time of diagnosis
  • known BCRA1/2 gene mutations (genetic testing not required)
  • any exclusion criterion in the local centre´s treatment policy
  Contacts and Locations
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): NCT02290782


Contacts
Contact: Frederik Wenz, MD, Prof. +496213836020 frederik.wenz@umm.de
Contact: Elena Sperk, MD +496213836020 elena.sperk@medma.uni-heidelberg.de

Locations
Germany
Department of Radiotherapy University Hospital Mannheim Recruiting
Mannheim, Germany, 68167
Contact: Frederik Wenz, Prof. Dr.    00496213834960    frederik.wenz@medma.uni-heidelberg.de   
Sponsors and Collaborators
Universitätsmedizin Mannheim
Investigators
Principal Investigator: Frederik Wenz department of radiation oncology
  More Information

Publications:

Responsible Party: Frederik Wenz, Prof. Dr. med. Frederik Wenz, Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier: NCT02290782     History of Changes
Other Study ID Numbers: TARGIT C
First Submitted: October 30, 2014
First Posted: November 14, 2014
Last Update Posted: October 27, 2017
Last Verified: October 2017

Keywords provided by Frederik Wenz, Universitätsmedizin Mannheim:
toxicity
outcome
TARGIT
quality of life
intraoperative radiotherapy (IORT)

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