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| Sponsor: | University Hospital Erlangen |
|---|---|
| Information provided by: | University Hospital Erlangen |
| ClinicalTrials.gov Identifier: | NCT01175694 |
Purpose
Accelerated partial breast irradiation (APBI) leads to a equivalent local control rate with lower toxicity as external beam irradiation (EBI) after breast conserving surgery (BCS) in a highly selected subgroup of patients with low risk invasive carcinoma and low risk duct carcinoma in-situ (DCIS). The goal of this trial is to assess the role of a modified dose of pulsed-dose-rate (PDR) and high-dose-rate (HDR) brachytherapy alone as Accelerated Partial Breast Irradiation (APBI) in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure (all ipsilateral local recurrences), in particular regarding the local recurrences, the toxicity and for the cosmetic result. It is a phase II study. According to study protocol altogether 200 female patients will be treated.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Radiation: Interstitial multicatheter brachytherapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study - Dose Optimization PDR/HDR Brachytherapy Alone for Early Breast Cancer |
| Estimated Enrollment: | 200 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Brachytherapy
Interstitial multicatheter brachytherapy
|
Radiation: Interstitial multicatheter brachytherapy
Interstitial PDR- and HDR-brachytherapy up to 50 Gy-eq
Other Name: APBI
|
Focus of this trial is to assess the role a modified dose of PDR- and HDR-brachytherapy as Accelerated Partial Breast Irradiation (APBI) alone in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure(all ipsilateral local recurrences, in particular regarding the local recurrences, the toxicity and for the cosmetic result.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion criteria
Exclusion Criteria:
Contacts and Locations| Contact: Vratislav Strnad, MD, Prof. | 49 9131 8544205 | vratislav.strnad@uk-erlangen.de |
| Germany | |
| Dept. of Radiation Oncology, University Hospital Erlangen | Recruiting |
| Erlangen, Germany, 91054 | |
| Contact: Vratislav Strnad, MD, Prof. 49 9131 8544205 vratislav.strnad@uk-erlangen.de | |
| Principal Investigator: Godehard Lahmer, MD | |
| Principal Investigator: | Vratislav Strnad, MD, Prof. | University Hospital Erlangen |
More Information
| Responsible Party: | Vratislav Strnad, MD, Prof., University Hospital Erlangen |
| ClinicalTrials.gov Identifier: | NCT01175694 History of Changes |
| Other Study ID Numbers: | Brachy-APBI-03 |
| Study First Received: | August 4, 2010 |
| Last Updated: | August 19, 2010 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Brachytherapy APBI dose modification |
local recurrences side effects cosmetic result |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |