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

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

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.

Study Overview

• Status: Completed
• Conditions: Neoplasms; Breast Neoplasms; Breast Diseases; Neoplasm Recurrence, Local
• Intervention / Treatment: Radiation: intraoperative radiotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 541
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Mannheim, Baden-Württemberg, Germany, 68167
      • Universitätsmedizin Mannheim UMM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intraoperative radiotherapy; single arm with intraoperative radiotherapy	Radiation: intraoperative radiotherapy; intraoperative single dose radiotherapy (20 Gy); Other Names: IORT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local Relapse	Rate of local relapse (within 2cm of the initial tumor bed)	up to ten years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Death is an event	up to ten years
Ipsi- or Contralateral Breast Cancer	Rate of ipsilateral and contralateral breast cancer events	up to ten years
Cosmesis	BCCT.Core analysis of cosmesis	up to 7.5 years
General and breast-specific Quality of Life after IORT	EORTC questionnaires QLQ C30 and BR23	up to 10 years
Late toxicity after IORT	LENT-SOMA based toxicity at all FU time points	up to ten years

Collaborators and Investigators

• Sponsor: Universitätsmedizin Mannheim
• Investigators: Principal Investigator: Sperk Elena, MD, Medical Faculty Mannheim

Publications and helpful links

General Publications

• Neumaier C, Elena S, Grit W, Yasser AM, Uta KT, Anke K, Axel G, Marc S, Frederik W. TARGIT-E(lderly)--prospective phase II study of intraoperative radiotherapy (IORT) in elderly patients with small breast cancer. BMC Cancer. 2012 May 8;12:171. doi: 10.1186/1471-2407-12-171.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ACTUAL): November 1, 2017
• Study Completion (ACTUAL): January 1, 2019

Study Registration Dates

• First Submitted: February 18, 2011
• First Submitted That Met QC Criteria: February 18, 2011
• First Posted (ESTIMATE): February 21, 2011

Study Record Updates

• Last Update Posted (ACTUAL): June 2, 2022
• Last Update Submitted That Met QC Criteria: May 30, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Intraoperative Radiotherapy; Elderly Patients; Early Breast Cancer; Keywords provided by University Hospital Mannheim:
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms by Site; Disease Attributes; Neoplastic Processes; Neoplasms; Breast Neoplasms; Recurrence; Breast Diseases; Neoplasm Recurrence, Local
• Other Study ID Numbers: TARGIT-E