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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2010 by Universitätsmedizin Mannheim
Sponsor:
Information provided by:
Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier:
NCT01299987
First received: February 18, 2011
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

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
Neoplasms
Radiation: intraoperative radiotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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 Universitätsmedizin Mannheim:

Primary Outcome Measures:
  • Local Relapse [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Rate of local relapse (within 2cm of the initial tumor bed)


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Ipsi- or Contralateral Breast Cancer [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Cosmesis [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 265
Study Start Date: January 2011
Estimated Study Completion Date: November 2025
Estimated Primary Completion Date: November 2015 (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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01299987

Contacts
Contact: Frederik Wenz, Prof Dr. 00496213834960 frederik.wenz@umm.de
Contact: Christian Neumaier 00496213836020 christian.neumaier@umm.de

Locations
Germany
Universitätsmedizin Mannheim UMM Recruiting
Mannheim, Baden-Württemberg, Germany, 68167
Contact: Frederik Wenz, Prof. Dr.    00496213834960    christian.neumaier@umm.de   
Contact: Christian Neumaier    00496213836020    christian.neumaier@umm.de   
Sponsors and Collaborators
Universitätsmedizin Mannheim
Investigators
Principal Investigator: Frederik Wenz, Prof. Dr. Medical Center Mannheim
  More Information

No publications provided by Universitätsmedizin Mannheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. med. F. Wenz, Department of Radiotherapy
ClinicalTrials.gov Identifier: NCT01299987     History of Changes
Other Study ID Numbers: TARGIT-E
Study First Received: February 18, 2011
Last Updated: February 18, 2011
Health Authority: Germany: Federal Office for Radiation Protection
Germany: Ethics Commission

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

Additional relevant MeSH terms:
Breast Diseases
Breast Neoplasms
Neoplasm Recurrence, Local
Neoplasms
Recurrence
Disease Attributes
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Skin Diseases

ClinicalTrials.gov processed this record on October 29, 2014