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

NCT ID: NCT01175694

Last Updated: 2010-08-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2015-01-31

Brief Summary

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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Brachytherapy

Interstitial multicatheter brachytherapy

Group Type: ACTIVE_COMPARATOR

Interstitial multicatheter brachytherapy

Intervention Type: RADIATION

Interstitial PDR- and HDR-brachytherapy up to 50 Gy-eq

Interventions

Interstitial multicatheter brachytherapy

Interstitial PDR- and HDR-brachytherapy up to 50 Gy-eq

Intervention Type: RADIATION

Other Intervention Names

APBI

Eligibility 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Erlangen

OTHER

Sponsor Role: lead

Responsible Party

University Hospital Erlangen

Principal Investigators

Vratislav Strnad, MD, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Erlangen

Locations

Dept. of Radiation Oncology, University Hospital Erlangen

Erlangen, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Vratislav Strnad, MD, Prof.

Role: CONTACT

vratislav.strnad@uk-erlangen.de

49 9131 8544205

Facility Contacts

Vratislav Strnad, MD, Prof.

Role: primary

vratislav.strnad@uk-erlangen.de

49 9131 8544205

Other Identifiers

Brachy-APBI-03

Identifier Type: -

Identifier Source: org_study_id