Dose Optimization for Pulsed-dose-rate (PDR)/High-dose-rate (HDR) Brachytherapy Alone for Early Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2010 by University Hospital Erlangen
Sponsor:
Information provided by:
University Hospital Erlangen
ClinicalTrials.gov Identifier:
NCT01175694
First received: August 4, 2010
Last updated: August 19, 2010
Last verified: June 2010

August 4, 2010
August 19, 2010
January 2010
June 2012   (final data collection date for primary outcome measure)
local control rates [ Time Frame: five years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01175694 on ClinicalTrials.gov Archive Site
late side effects [ Time Frame: 5 years ] [ Designated as safety issue: No ]
to assess the incidence and severity of acute and late side effects of brachytherapy
Same as current
Not Provided
Not Provided
 
Dose Optimization for Pulsed-dose-rate (PDR)/High-dose-rate (HDR) Brachytherapy Alone for Early Breast Cancer
Phase II Study - Dose Optimization PDR/HDR Brachytherapy Alone for Early Breast Cancer

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
Radiation: Interstitial multicatheter brachytherapy
Interstitial PDR- and HDR-brachytherapy up to 50 Gy-eq
Other Name: APBI
Active Comparator: Brachytherapy
Interstitial multicatheter brachytherapy
Intervention: Radiation: Interstitial multicatheter brachytherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
January 2015
June 2012   (final data collection date for primary outcome measure)

Inclusion criteria

  • Stage 0, I or II breast cancer.
  • Invasive ductal, papillary, mucinous, tubular, medullary or lobular carcinoma.
  • Ductal carcinoma in situ (DCIS) alone.
  • No lymph invasion (L0) and no hemangiosis (V0).
  • Lesions of < 3 cm diameter, histopathologically assured.
  • pN0 (a minimum of 6 nodes in specimen, or a negative sentinel node is acceptable).
  • M0.
  • Clear resection margins at least 2 mm in any direction; by lobular histology or DCIS histology only the resection margins must be clear at least 5 mm.
  • For DCIS only: lesions must be classified as low or intermediate risk group
  • Unifocal and unicentric DCIS or breast cancer.
  • Age > 50 years.
  • Time interval from final definitive breast surgical procedure to the start of external beam therapy or to brachytherapy is less than 12 weeks (84 days). If patients receive chemotherapy the radiotherapy can be started before systemic treatment (within 12 weeks). The radiation therapy can be also given in the interval between the chemotherapy courses. It is also possible to start radiation therapy after chemotherapy is completed according local protocols as soon as possible within 4 weeks after chemotherapy.
  • Signed study-specific consent form

Exclusion Criteria:

  • Stage III or IV breast cancer.
  • Surgical margins that cannot be microscopically assessed.
  • Extensive intraductal component (EIC).
  • Paget's disease or pathological skin involvement.
  • Synchronous or previous breast cancer.
  • Prior malignancy (< 5 years prior to enrollment in study) except non-melanoma skin cancer or cervical carcinoma International Federation of Gynecology and Obstetrics (FIGO) 0 and I if patient is continuously disease-free.
  • Pregnant or lactating women.
  • Collagen vascular disease.
  • The presence of congenital diseases with increased radiation sensitivity, for example Ataxia telangiectatic or similar.
  • Psychiatric disorders.
  • Patient with breast deemed technically unsatisfactory for brachytherapy.
Female
50 Years and older
No
Contact: Vratislav Strnad, MD, Prof. 49 9131 8544205 vratislav.strnad@uk-erlangen.de
Germany
 
NCT01175694
Brachy-APBI-03
No
Vratislav Strnad, MD, Prof., University Hospital Erlangen
University Hospital Erlangen
Not Provided
Principal Investigator: Vratislav Strnad, MD, Prof. University Hospital Erlangen
University Hospital Erlangen
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP