Trial document




This trial has been registered retrospectively.
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  DRKS00004417

Trial Description

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Title

Phase II-Trial:
3D-conformal, external beam accelerated partial breast irradiation for patients with pT1/2pN0 breast cancer after breast conserving surgery

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The APBI V-trial evaluates the feasibility and effectiveness of an accelerated partial breast irradiation (APBI) in women with breast cancer after breast conserving surgery. Current standard treatment is the whole breast irradiation over a treatment period of approxomately 7 weeks. With APBI it is possible to limit the irradiation time to 1-2 weeks. Target volume is not the whole breast but the tumor bed including safety margins. A total dose of 38 Gy (10 x 3.8 Gy) is applied. Study participation is possible for patients with low-risk breast cancer and a minimum age of 50 years. The aim of the study is to evaluate the rate of side effects and the rate of local recurrences.

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Brief Summary in Scientific Language

The APBI V-trial evaluates the feasibility and effectiveness of an adjuvant, external beam, 3D-conformal accelerated partial breast irradiation (APBI) in women with low-risk breast cancer after breast conserving surgery. Current standard treatment is the whole breast irradiation over a treatment period of approxomately 7 weeks and up to a total dose of 66 Gy including boost irradiation. With APBI it is possible to limit the irradiation time to 1-2 weeks. Target volume is not the whole breast but the tumor bed including safety margins. A total dose of 38 Gy (10 x 3.8 Gy) is applied with a dedicated stereotactic linac using image-guidance (tumor bed clips) before each fraction. Study participation is possible for patients with low-risk breast cancer and a minimum age of 50 years. The aim of the study is to evaluate the feasibility and efficacy in terms of local control for this selected group of patients.

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Organizational Data

  •   DRKS00004417
  •   2012/10/29
  •   [---]*
  •   yes
  •   Approved
  •   4275, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C50.9 -  Malignant neoplasm: Breast, unspecified
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Interventions/Observational Groups

  •   10 x 3.80 Gy up to 38 Gy (ICRU-50 reference point). 1 or 2 daily fractions of 3.80 Gy, with a daily break of at least 6 hours in between. Treatment is applied in 5-10 consecutive working days. Irradiation is applied with an image guided stereotatic linac using tumor bed clips for exact positioning before each fraction.
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Locoregional tumor control will be determined clinically and mammographically as well as with ultrasound examination every 6 months during the first five years of follow-up, and every 12 months in the years 6 to 10.

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Secondary Outcome

Incidence and severity of side effects by clinical examination every 6 months during years 1-5 and every 12 months during years 6-10 of follow-up.
Cosmetic outcome by clinical examination and unsing the Harvard scale every 6 months during years 1-5 and every 12 months during years 6-10 of follow-up.
Quality of life (QoL) by using EORTC-questionnaires (QLQ C-30 and BR-23) every 6 months during years 1-5 and every 12 months during years 6-10 of follow-up.
Local-recurrence-free survival using clinical examination, mammograms and ultrasound of the involved breast every 6 months during years 1-5 and every 12 months during years 6-10 of follow-up.
Disease-free survival using clinical examination, mammograms and ultrasound of the involved breast every 6 months during years 1-5 and every 12 months during years 6-10 of follow-up.
Overall survival using clinical examination every 6 months during years 1-5 and every 12 months during years 6-10 of follow-up.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2011/03/31
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   50   Years
  •   no maximum age
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Additional Inclusion Criteria

Histologically confirmed breast cancer or ductal carcinoma in situ (DCIS)
pT1-2 breast cancer ≤ 3 cm
Complete resection (R0)
No or microscopic axillary involvement (pN0 or pN0sn, pN1mi).
No distant metastases (M0)
No contralateral breast cancer/DCIS
Karnofsky-Index ≥ 60%.
Age ≥ 50 years.
Hormonal sensitive tumors (ER+/PR+; ER+/PR-; ER-/PR+).
Safety margin ≥ 5 mm for invasive-lobular cancer and DCIS, for al others ≥ 2mm.
Tumor bed clips.
Written informed consent.

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Exclusion Criteria

All patients who do not fit inclusion criteria.
Multicentric groth pattern.
Diffuse microcalcifications.
Extensive intraductal component (EIC).
Peritumoral vessel involvement (L1, V1)
Unclear margins
Anthracyclin-based chemotherapy.
Morbus Paget or pathological skin infiltration.
Synchrone or past breast cancer in the history.
Earlier malignancy within 5 years before study recruitment with exception of non-melanoma skin cancer or cervical cancer FIGO I.
Pregnant or lactating women.
Soft tissue disease.
Genetic predisposition for increased radiosensitivity, e.g. Ataxia telangiectatica or comparable.
Psychiatric disorders decreased compliance.
Patients in which APBI is technically not practicable.

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Addresses

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    • Universitätsklinikum Erlangen Strahlenklinik
    • Mr.  PD Dr. med.  Oliver  Ott 
    • Universitätsstr. 27
    • 91054  Erlangen
    • Germany
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    • Universitätsklinikum Erlangen Strahlenklinik
    • Mr.  PD Dr. med.  Oliver  Ott 
    • Universitätsstr. 27
    • 91054  Erlangen
    • Germany
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    • Universitätsklinikum Erlangen Strahlenklinik
    • Mr.  PD Dr. med.  Oliver  Ott 
    • Universitätsstr. 27
    • 91054  Erlangen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Erlangen Strahlenklinik
    • Mr.  PD Dr. med.  Oliver  Ott 
    • Universitätsstr. 27
    • 91054  Erlangen
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.