Clinical trial NCT01299987: Prospective Phase II Study of Intraoperative Radiotherapy (IORT) in Elderly Patients with Small Breast Cancer
Official title: TARGIT-E(Elderly) Prospective Phase II Study of Intraoperative Radiotherapy (IORT) in Elderly Patients with Small Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Breast Diseases
Neoplasm Recurrence, Local
Neoplasms
Keywords: Keywords provided by University Hospital Mannheim:
Intraoperative Radiotherapy
Early Breast Cancer
Elderly Patients
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2011-02-21
Enrollment: 591
Sex: FEMALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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)

Primary outcomes:
measure: Local Relapse
timeFrame: up to ten years
Secondary outcomes:
measure: Overall Survival
timeFrame: up to ten years
measure: Ipsi- or Contralateral Breast Cancer
timeFrame: up to ten years
measure: Cosmesis
timeFrame: up to 7.5 years
measure: General and breast-specific Quality of Life after IORT
timeFrame: up to 10 years
measure: Late toxicity after IORT
timeFrame: up to ten years
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim UMM
state: Baden-Württemberg
Study officials:
affiliation: Medical Faculty Mannheim
name: Sperk Elena, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.