Prospective Phase II Study of Intraoperative Radiotherapy (IORT) in Elderly Patients With Small Breast Cancer (TARGIT-E)
Primary Purpose
Breast Neoplasms, Breast Diseases, Neoplasm Recurrence, Local
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
intraoperative radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasms focused on measuring Keywords provided by University Hospital Mannheim:, Intraoperative Radiotherapy, Early Breast Cancer, Elderly Patients
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)
Sites / Locations
- Universitätsmedizin Mannheim UMM
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intraoperative radiotherapy
Arm Description
single arm with intraoperative radiotherapy
Outcomes
Primary Outcome Measures
Local Relapse
Rate of local relapse (within 2cm of the initial tumor bed)
Secondary Outcome Measures
Overall Survival
Death is an event
Ipsi- or Contralateral Breast Cancer
Rate of ipsilateral and contralateral breast cancer events
Cosmesis
BCCT.Core analysis of cosmesis
General and breast-specific Quality of Life after IORT
EORTC questionnaires QLQ C30 and BR23
Late toxicity after IORT
LENT-SOMA based toxicity at all FU time points
Full Information
NCT ID
NCT01299987
First Posted
February 18, 2011
Last Updated
May 30, 2022
Sponsor
Universitätsmedizin Mannheim
1. Study Identification
Unique Protocol Identification Number
NCT01299987
Brief Title
Prospective Phase II Study of Intraoperative Radiotherapy (IORT) in Elderly Patients With Small Breast Cancer
Acronym
TARGIT-E
Official Title
TARGIT-E(Elderly) Prospective Phase II Study of Intraoperative Radiotherapy (IORT) in Elderly Patients With Small Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
January 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitätsmedizin Mannheim
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Breast Diseases, Neoplasm Recurrence, Local, Neoplasms
Keywords
Keywords provided by University Hospital Mannheim:, Intraoperative Radiotherapy, Early Breast Cancer, Elderly Patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
541 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intraoperative radiotherapy
Arm Type
Experimental
Arm Description
single arm with intraoperative radiotherapy
Intervention Type
Radiation
Intervention Name(s)
intraoperative radiotherapy
Other Intervention Name(s)
IORT
Intervention Description
intraoperative single dose radiotherapy (20 Gy)
Primary Outcome Measure Information:
Title
Local Relapse
Description
Rate of local relapse (within 2cm of the initial tumor bed)
Time Frame
up to ten years
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Death is an event
Time Frame
up to ten years
Title
Ipsi- or Contralateral Breast Cancer
Description
Rate of ipsilateral and contralateral breast cancer events
Time Frame
up to ten years
Title
Cosmesis
Description
BCCT.Core analysis of cosmesis
Time Frame
up to 7.5 years
Title
General and breast-specific Quality of Life after IORT
Description
EORTC questionnaires QLQ C30 and BR23
Time Frame
up to 10 years
Title
Late toxicity after IORT
Description
LENT-SOMA based toxicity at all FU time points
Time Frame
up to ten years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sperk Elena, MD
Organizational Affiliation
Medical Faculty Mannheim
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsmedizin Mannheim UMM
City
Mannheim
State/Province
Baden-Württemberg
ZIP/Postal Code
68167
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
22569123
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.
Results Reference
derived
Learn more about this trial
Prospective Phase II Study of Intraoperative Radiotherapy (IORT) in Elderly Patients With Small Breast Cancer
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