Prospective Phase II Study of Intraoperative Radiotherapy (IORT) in Elderly Patients With Small Breast Cancer (TARGIT-E)
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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 |
- Local Relapse [ Time Frame: 10 years ] [ Designated as safety issue: No ]Rate of local relapse (within 2cm of the initial tumor bed)
- 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 |
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| Contact: Frederik Wenz, Prof Dr. | 00496213834960 | frederik.wenz@umm.de |
| Contact: Christian Neumaier | 00496213836020 | christian.neumaier@umm.de |
| 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 | |
| Principal Investigator: | Frederik Wenz, Prof. Dr. | Medical Center Mannheim |
More Information
No publications provided by University Hospital 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 University Hospital Mannheim:
|
Keywords provided by University Hospital Mannheim: Intraoperative Radiotherapy Early Breast Cancer Elderly Patients |
Additional relevant MeSH terms:
|
Breast Neoplasms Breast Diseases Neoplasms Neoplasm Recurrence, Local Recurrence |
Neoplasms by Site Skin Diseases Neoplastic Processes Pathologic Processes Disease Attributes |
ClinicalTrials.gov processed this record on May 23, 2013