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

  • STATUS
    Recruiting
  • End date
    Jun 21, 2023
  • participants needed
    2324
  • sponsor
    University Hospital Schleswig-Holstein
Updated on 21 January 2021
estrogen
her-2
bisphosphonate
breast conserving surgery
mastectomy

Summary

Hypofractionation with simultaneous integrated boost has been investigated in a few trials and appears to be safe and feasible.

Investigators initiated this multicenter two-armed phase III prospective trial to analyse the non-inferiority of hypofractionation with simultaneous integrated boost in patients with early breast cancer in comparison to standard fractionation.

Description

Control Arm:

Conventionaly fractionated radiotherapy of the breast 28 1.8 Gy = 50.4 Gy followed by a tumor bed boost sequentially 5 to 8 2.0 Gy = 10.0 Gy to 16.0 Gy, total dose 60.4 Gy to 66.4 Gy.

or Conventionaly fractionated radiotherapy of the breast 28 1.8 Gy = 50.4 Gy with simultaneous integrated boost to the tumor bed, total dose 28 0.3 Gy or 0.45 Gy= 8.4 Gy or 12,6 Gy, total dose 58,8 Gy to 63.0 Gy.

or Hypofractionated radiotherapy of the breast 16 2.66 Gy = 42.56 Gy followed by a tumor bed boost sequentially 5 to 8 2.0 Gy = 10.0 Gy to 16.0 Gy, total dose 52.56 Gy to 58.56 Gy.

Experimental Arm:

Hypofractionated radiotherapy of the breast 16 2.50 Gy with simultaneous integrated boost to the tumor bed, total dose within the boost volume 16 3.00 Gy.

Details
Condition Early Stage Breast Carcinoma
Treatment Standard Radiation, Hypofractionation with SIB
Clinical Study IdentifierNCT02474641
SponsorUniversity Hospital Schleswig-Holstein
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

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
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