Overview

This trial is active, not recruiting.

Conditions breast neoplasms, breast diseases, neoplasm recurrence, local, neoplasms
Treatment intraoperative radiotherapy
Phase phase 2
Sponsor Universitätsmedizin Mannheim
Start date January 2011
End date November 2017
Trial size 265 participants
Trial identifier NCT01299987, TARGIT-E

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
single arm with intraoperative radiotherapy
intraoperative radiotherapy IORT
intraoperative single dose radiotherapy (20 Gy)

Primary Outcomes

Measure
Local Relapse
time frame: 10 years

Secondary Outcomes

Measure
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

Eligibility Criteria

Female participants at least 70 years old.

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)

Additional Information

Official title TARGIT-E(Elderly) Prospective Phase II Study of Intraoperative Radiotherapy (IORT) in Elderly Patients With Small Breast Cancer
Principal investigator Frederik Wenz, Prof. Dr.
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Universitätsmedizin Mannheim.