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

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ClinicalTrials.gov Identifier: NCT02290782
Recruitment Status : Recruiting
First Posted : November 14, 2014
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. med. Elena Sperk, 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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Study Start Date : October 2014
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

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



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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
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

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
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Contact: Elena Sperk, MD +496213836020 elena.sperk@umm.de

Locations
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France
Institut régional du Cancer de Montpellier Recruiting
Montpellier, France, 34298
Contact: Claire Lemanski, MD         
Contact: Laetitia Meignant    04 67 61 47 38    Laetitia.Meignant@icm.unicancer.fr   
IUCT, Toulouse Recruiting
Toulouse, France
Contact: Francoise Izar, MD       Izar.Francoise@iuct-oncopole.fr   
Contact: Gabrielle SELMES, MD         
Germany
Klinikum Kassel Recruiting
Kassel, Germany, 34125
Contact: Gabriele Feisel-Schwickardi, MD       gabriele.feisel@klinikum-kassel.de   
Contact: Ralf Keymer, MD       ralf.keymer@klinikum-kassel.de   
Department of Radiotherapy University Hospital Mannheim Recruiting
Mannheim, Germany, 68167
Contact: Elena Sperk, MD    00496213836020    elena.sperk@umm.de   
Sponsors and Collaborators
Universitätsmedizin Mannheim
Investigators
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Principal Investigator: Elena Sperk, MD department of radiation oncology
Publications:

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Responsible Party: Dr. med. Elena Sperk, 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: November 24, 2020
Last Verified: November 2020
Keywords provided by Dr. med. Elena Sperk, Universitätsmedizin Mannheim:
toxicity
outcome
TARGIT
quality of life
intraoperative radiotherapy (IORT)
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases