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Prospective Phase II Study of Intraoperative Radiotherapy (IORT) in Elderly Patients With Small Breast Cancer (TARGIT-E)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Frederik Wenz, Universitätsmedizin Mannheim Identifier:
First received: February 18, 2011
Last updated: January 18, 2016
Last verified: January 2016
This prospective, multicentric single arm phase II study is based on the protocol of the international TARGIT-A study. The purpose is to investigate the efficacy of a single intraoperative radiotherapy treatment within elderly low risk patients (≥ 70 years, cT1, cN0, cM0, invasive-ductal) which is followed by WBRT only when risk factors are present. In presence of risk factors postoperative WBRT will be added to complete the radiotherapeutic treatment according to international guidelines.

Condition Intervention Phase
Breast Neoplasms
Breast Diseases
Neoplasm Recurrence, Local
Radiation: intraoperative radiotherapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: TARGIT-E(Elderly) Prospective Phase II Study of Intraoperative Radiotherapy (IORT) in Elderly 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: 10 years ]
    Rate of local relapse (within 2cm of the initial tumor bed)

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 10 years ]
  • Ipsi- or Contralateral Breast Cancer [ Time Frame: 10 years ]
  • Cosmesis [ Time Frame: 10 years ]
  • Quality of Life [ Time Frame: 10 years ]
  • Toxicity [ Time Frame: 10 years ]

Estimated Enrollment: 265
Study Start Date: January 2011
Estimated Study Completion Date: November 2025
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intraoperative radiotherapy
single arm with intraoperative radiotherapy
Radiation: intraoperative radiotherapy
intraoperative single dose radiotherapy (20 Gy)
Other Name: IORT

Detailed Description:

Patients ≥ 70 years with small, low-risk breast cancer who are operated but not irradiated show local relapse rates around 4% after 4 years. With adjuvant whole breast radiotherapy (WBRT) the local relapse rate drops to 1% after 4 years under Tamoxifen (Hughes et al 2004). It has been demonstrated (Polgar et al. 2007, Vaidya et al. 2010) that the efficacy of radiation of the tumor bed only in a selected group can be non-inferior to WBRT. The TARGIT E study should confirm the efficacy of a single dose of intraoperative radiotherapy (IORT) in a well selected group of elderly 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 0.5/1/1.5% after 2.5/5/7.5 years, respectively.

Discontinuation of the trial is scheduled if rates of local relapse rates rise to 3/4/6% after 2.5/5/7.5 years. Power calculations result in 265 patients with a calculated loss to follow-up of 20%, an alpha of 0.05 and a beta 0.1. Only centers with access to the Intrabeam® system (Carl Zeiss) can recruit patients into the trial.


Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • cT1c cN0 cM0
  • ≥ 70 years old
  • invasive-ductal histology
  • compliance
  • informed consent

Exclusion Criteria:

  • extensive intraductal component (EIC)
  • multifocality /-centricity
  • lymph vessel invasion (L1)
  • clinical signs of distant metastases or clinically suspicious lymph nodes
  • other histology
  • < 70 years old
  • missing informed consent or non-compliance
  • bilateral breast cancer at time of diagnosis
  • known BRACA 1/2 mutations (genetic testing not required)
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Please refer to this study by its identifier: NCT01299987

Universitätsmedizin Mannheim UMM
Mannheim, Baden-Württemberg, Germany, 68167
Sponsors and Collaborators
Universitätsmedizin Mannheim
Principal Investigator: Frederik Wenz, Prof. Dr. Medical Center Mannheim
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Frederik Wenz, Prof., Universitätsmedizin Mannheim Identifier: NCT01299987     History of Changes
Other Study ID Numbers: TARGIT-E
Study First Received: February 18, 2011
Last Updated: January 18, 2016

Keywords provided by Frederik Wenz, Universitätsmedizin Mannheim:
Keywords provided by University Hospital Mannheim:
Intraoperative Radiotherapy
Early Breast Cancer
Elderly Patients

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasm Recurrence, Local
Neoplasms by Site
Skin Diseases
Disease Attributes
Pathologic Processes
Neoplastic Processes processed this record on May 25, 2017