Last updated on February 2018

Hypofractionation With Simultaneous Integrated Boost vs. Standard Fractionation in Early Breast Cancer

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Early Stage Breast Carcinoma
  • Age: Between 18 - 100 Years
  • Gender: Female

Inclusion Criteria:

  • Histopathologically confirmed breast cancer operated by breast conserving surgery with clear margins independently of further risk factors (positive or high-risk negative lymph node status, estrogen- or progesterone receptor status, Her-2/neu status uPA/PAI-1 criteria) and postoperative systemic therapy (chemotherapy, endocrine, antibody or bisphosphonate therapy were permitted when indicated)
  • Indication to adjuvant radiotherapy including boost radiotherapy
  • Clearly identified primary tumor region preferably by radiopaque clips
  • Primary wound healing after breast conserving therapy without signs of infection
  • Age 18 years
  • ECOG 2 Performance Status
  • Written informed consent
  • Compliance regarding treatment appointments and toxicity
  • Linguistic and cognitive ability to understand the questionnaires

Exclusion Criteria:

  • Patients operated by mastectomy
  • No indication for boost radiation (e.g. status after IORT)
  • double sided breast cancer
  • Resection margins positive for disease or insufficient identification of the boost volume
  • Indication for radiotherapy of the regional lymph nodes
  • History of prior breast or thoracic radiotherapy
  • Extended postoperative seroma at the beginning of radiotherapy
  • Previously administered radiotherapy not allowing the required dose
  • Pregnant or lactating patients and woman of child bearing potential, who lacked effective contraception
  • treatment history of other cancer or participation in another clinical trial testing radiotherapy or drugs within 4 weeks of the start of treatment.
  • Patients with serious, uncontrolled, physical or cerebrovascular disorders(e.g. myocardial infarction within the last 12 months) or neurologiy or psychiatric disorders thought to adversly affect treatment compliance

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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