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

Neoplasms Clinical Trial

— TARGIT-E  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01299987
• Other study ID #: TARGIT-E
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: January 2019

Study information

• Verified date: May 2022
• Source: Universitätsmedizin Mannheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 541
• Est. completion date: January 2019
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 70 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Diseases
• Breast Neoplasms
• Neoplasm Recurrence, Local
• Neoplasms
• Recurrence

Intervention

Radiation:
• intraoperative radiotherapy
intraoperative single dose radiotherapy (20 Gy)

Locations

Country	Name	City	State
Germany	Universitätsmedizin Mannheim UMM	Mannheim	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsmedizin Mannheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Relapse	Rate of local relapse (within 2cm of the initial tumor bed)	up to ten years
Secondary	Overall Survival	Death is an event	up to ten years
Secondary	Ipsi- or Contralateral Breast Cancer	Rate of ipsilateral and contralateral breast cancer events	up to ten years
Secondary	Cosmesis	BCCT.Core analysis of cosmesis	up to 7.5 years
Secondary	General and breast-specific Quality of Life after IORT	EORTC questionnaires QLQ C30 and BR23	up to 10 years
Secondary	Late toxicity after IORT	LENT-SOMA based toxicity at all FU time points	up to ten years