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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Interstitial multicatheter brachytherapy
Sponsored by
University Hospital Erlangen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Brachytherapy, APBI, dose modification, local recurrences, side effects, cosmetic result

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Dept. of Radiation Oncology, University Hospital ErlangenRecruiting

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Brachytherapy

Arm Description

Interstitial multicatheter brachytherapy

Outcomes

Primary Outcome Measures

local control rates

Secondary Outcome Measures

late side effects
to assess the incidence and severity of acute and late side effects of brachytherapy

Full Information

First Posted
August 4, 2010
Last Updated
August 19, 2010
Sponsor
University Hospital Erlangen
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1. Study Identification

Unique Protocol Identification Number
NCT01175694
Brief Title
Dose Optimization for Pulsed-dose-rate (PDR)/High-dose-rate (HDR) Brachytherapy Alone for Early Breast Cancer
Official Title
Phase II Study - Dose Optimization PDR/HDR Brachytherapy Alone for Early Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
January 2015 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Erlangen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Brachytherapy, APBI, dose modification, local recurrences, side effects, cosmetic result

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brachytherapy
Arm Type
Active Comparator
Arm Description
Interstitial multicatheter brachytherapy
Intervention Type
Radiation
Intervention Name(s)
Interstitial multicatheter brachytherapy
Other Intervention Name(s)
APBI
Intervention Description
Interstitial PDR- and HDR-brachytherapy up to 50 Gy-eq
Primary Outcome Measure Information:
Title
local control rates
Time Frame
five years
Secondary Outcome Measure Information:
Title
late side effects
Description
to assess the incidence and severity of acute and late side effects of brachytherapy
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vratislav Strnad, MD, Prof.
Phone
49 9131 8544205
Email
vratislav.strnad@uk-erlangen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vratislav Strnad, MD, Prof.
Organizational Affiliation
University Hospital Erlangen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Radiation Oncology, University Hospital Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vratislav Strnad, MD, Prof.
Phone
49 9131 8544205
Email
vratislav.strnad@uk-erlangen.de
First Name & Middle Initial & Last Name & Degree
Godehard Lahmer, MD

12. IPD Sharing Statement

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

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