We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02290782
Recruitment Status : Active, not recruiting
First Posted : November 14, 2014
Last Update Posted : June 1, 2022
Information provided by (Responsible Party):
Elena Sperk, MD, Universitätsmedizin Mannheim

Brief Summary:

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 or disease Intervention/treatment Phase
Breast Cancer Radiation: Intraoperative radiotherapy (IORT) Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 387 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm study: IORT +/- EBRT (risk adapted approach).
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
Actual Study Start Date : October 2014
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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.

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

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

  2. Survival [ Time Frame: 5 years ]
    Breast cancer related and overall survival

  3. Toxicity (CTC, LENT SOMA) [ Time Frame: 5 years ]
    Cosmetic outcome, acute and late toxicity measured by CTC Score V5 and LENT SOMA scale (fibrosis, telangiectasia, edema arm, edema breast, ulceration, hyperpigmentation, pain, retraction

  4. General QoL and breast specific QoL (EORTC QLQ C30 + BR23) [ Time Frame: 5 years ]
    measured by EORTC QLQ C30 and BR23 questionnaires; longitudinal analysis

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   breast cancer in females
Accepts Healthy Volunteers:   No

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

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

Layout table for location information
Institut régional du Cancer de Montpellier
Montpellier, France, 34298
IUCT, Toulouse
Toulouse, France
Klinikum Kassel
Kassel, Germany, 34125
Department of Radiotherapy University Hospital Mannheim
Mannheim, Germany, 68167
Sponsors and Collaborators
Universitätsmedizin Mannheim
Layout table for investigator information
Principal Investigator: Elena Sperk, MD department of radiation oncology

Layout table for additonal information
Responsible Party: Elena Sperk, MD, Head, Clinical Trials Unit, Department of Radiation Oncology Mannheim, Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier: NCT02290782    
Other Study ID Numbers: TARGIT C
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: June 1, 2022
Last Verified: May 2022
Keywords provided by Elena Sperk, MD, Universitätsmedizin Mannheim:
quality of life
intraoperative radiotherapy (IORT)
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases