TARGIT-C(Consolidation) Prospective Phase IV Study of IORT in Patients With Small Breast Cancer (TARGIT-C)
This prospective, multicentric single arm phase IV study is based on the protocol of the international TARGIT-A and TARGIT-E study.
Patients ≥ 50 years with small, low-risk breast cancer who are operated but not irradiated show local relapse rates around 6% after 5 years. With adjuvant whole breast radiotherapy (WBRT) the local relapse rate drops to under 1% after 5 years under Tamoxifen (4).
It has been demonstrated (6, 9, 10) that the efficacy of radiation of the tumor bed only in a selected group can be non-inferior to WBRT.
The TARGIT C study should confirm the efficacy of a single dose of intraoperative radiotherapy (IORT) in a well selected group of 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 0.825/1.375% after 3/5 years, respectively. Discontinuation of the trial is scheduled if rates of local relapse rates rise to 1.55/2.4/4% after 1/3/5 years. Power calculations result in 387 patients with a calculated dropout and loss to follow-up rate of 10%, an alpha of 0.05 and a beta of 0.10. There will be only a pre-pathology stratum.
It is a pragmatic trial in which each participating centre has the option to modify entry criteria and criteria for WBRT according to this core protocol after consultation with the steering committee and local ethics committee (e.g. size, free margins). Only centers with access to the Intrabeam® system (Carl Zeiss) can recruit patients into the trial.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||TARGIT-C(Consolidation) Prospective Phase IV Study of Intraoperative Radiotherapy (IORT) in Patients With Small Breast Cancer|
- Local relapse [ Time Frame: 5 years ]Local relapse rate within 2 cm of the tumor bed
- Ipsi- or contralateral breast cancer [ Time Frame: 5 years ]Ipsi- or contralateral breast cancer
- Survival [ Time Frame: 5 years ]cancer specific and overall survival
- Toxicity (CTC, LENT SOMA) [ Time Frame: 5 years ]cosmetic outcome, acute and late toxicity measured by CTC Score and LENT SOMA scale
- Quality of Life [ Time Frame: 5 years ]Quality of life measured by EORTC QLQ C30 and BR23
|Study Start Date:||October 2014|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: Intraoperative radiotherapy (IORT)
IORT (20Gy) as intervention will be given during breast conserving surgery. If risk factors (Tumor > 3.5 cm, lobular cancer, resection margin < 2 mm*, L1, pN+ mulitfocal/multicentric, EIC, negative hormone receptors) are present, external beam radiotherapy will be added.
* In case of positive margins (<2 mm resection margin) a re-resection should be done
Radiation: Intraoperative radiotherapy (IORT)
The surgeon and radiation oncologist should choose the largest possible suitable applicator in order to ensure that the highest possible dose is delivered to the tumor bed tissue. A dose of 20 Gy at the surface of the applicator (in water) is prescribed by the radiation oncologist and delivered to the breast tissue. This takes approximately 20-50 minutes, depending on the size of the applicator.
To minimize radiation dependent side effects the skin-applicator surface distance should be more than 5 mm.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT02290782
|Contact: Frederik Wenz, MD, Prof.||+email@example.com|
|Contact: Elena Sperk, MDfirstname.lastname@example.org|
|Department of Radiotherapy University Hospital Mannheim||Recruiting|
|Mannheim, Germany, 68167|
|Contact: Frederik Wenz, Prof. Dr. 00496213834960 email@example.com|
|Principal Investigator:||Frederik Wenz||department of radiation oncology|