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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
  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 2

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

Resource links provided by NLM:


Further study details as provided by University Hospital Erlangen:

Primary Outcome Measures:
  • local control rates [ Time Frame: five years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


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

Detailed Description:

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
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01175694

Contacts
Contact: Vratislav Strnad, MD, Prof. 49 9131 8544205 vratislav.strnad@uk-erlangen.de

Locations
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         
Sponsors and Collaborators
University Hospital Erlangen
Investigators
Principal Investigator: Vratislav Strnad, MD, Prof. University Hospital Erlangen
  More Information

No publications provided

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

Keywords provided by University Hospital Erlangen:
Brachytherapy
APBI
dose modification
local recurrences
side effects
cosmetic result

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 20, 2014