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

NCT01175694 | Unknown Phase 2

• 1 other identifier: Brachy-APBI-03
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Brachytherapy; APBI; dose modification; local recurrences; side effects; cosmetic result

Outcome Measures

Primary Outcomes (1)

• local control rates

  five years

Secondary Outcomes (1)

• late side effects

  5 years

Study Arms (1)

Brachytherapy

ACTIVE COMPARATOR

Interstitial multicatheter brachytherapy

Radiation: Interstitial multicatheter brachytherapy

Interventions

Interstitial multicatheter brachytherapy RADIATION

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

Also known as: APBI

Brachytherapy

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Erlangen: lead

Study Sites (1)

Dept. of Radiation Oncology, University Hospital Erlangen

Erlangen, 91054, Germany

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Vratislav Strnad, MD, Prof.

  University Hospital Erlangen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vratislav Strnad, MD, Prof.

CONTACT

49 9131 8544205; vratislav.strnad@uk-erlangen.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 4, 2010
• First Posted: August 5, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: January 1, 2015
• Last Updated: August 20, 2010

Record last verified: 2010-06

Locations

DE (1)