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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Radiation: Interstitial multicatheter brachytherapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Erlangen, Germany, 91054
    • Recruiting
    • Dept. of Radiation Oncology, University Hospital Erlangen
    • Contact: Vratislav Strnad, MD, Prof.; Phone Number: 49 9131 8544205; Email: vratislav.strnad@uk-erlangen.de
    • Principal Investigator: Godehard Lahmer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Brachytherapy; Interstitial multicatheter brachytherapy	Radiation: Interstitial multicatheter brachytherapy; Interstitial PDR- and HDR-brachytherapy up to 50 Gy-eq; Other Names: APBI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
local control rates	five years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
late side effects	to assess the incidence and severity of acute and late side effects of brachytherapy	5 years

Collaborators and Investigators

• Sponsor: University Hospital Erlangen
• Investigators: Principal Investigator: Vratislav Strnad, MD, Prof., University Hospital Erlangen

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (ANTICIPATED): June 1, 2012
• Study Completion (ANTICIPATED): January 1, 2015

Study Registration Dates

• First Submitted: August 4, 2010
• First Submitted That Met QC Criteria: August 4, 2010
• First Posted (ESTIMATE): August 5, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): August 20, 2010
• Last Update Submitted That Met QC Criteria: August 19, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: Brachytherapy; side effects; APBI; dose modification; local recurrences; cosmetic result
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: Brachy-APBI-03