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

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ClinicalTrials.gov Identifier: NCT02474641
Recruitment Status : Active, not recruiting
First Posted : June 18, 2015
Last Update Posted : August 25, 2021
Sponsor:
Collaborator:
University of Luebeck
Information provided by (Responsible Party):
Juergen Dunst, Prof., University Hospital Schleswig-Holstein

Brief 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.


Condition or disease Intervention/treatment Phase
Early-Stage Breast Carcinoma Radiation: Standard Radiation Radiation: Hypofractionation with SIB Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adjuvant Radiotherapy After Breast-conserving Surgery in Early Breast Cancer: Hypofractionation With Simultaneous Integrated Boost vs. Standard Fractionation
Actual Study Start Date : June 16, 2015
Actual Primary Completion Date : January 8, 2019
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: Standard radiation

Conventionally fractionated radiotherapy of the breast followed by a tumor bed boost sequentially or

Conventionally fractionated radiotherapy of the breast with simultaneous integrated boost to the tumor bed or

Hypofractionated radiotherapy of the breast followed by a tumor bed boost sequentially

Radiation: Standard Radiation

Conventionally fractionated radiotherapy of the breast followed by a tumor bed boost sequentially or

Conventionally fractionated radiotherapy of the breast with simultaneous integrated boost to the tumor bed or

Hypofractionated radiotherapy of the breast followed by a tumor bed boost sequentially


Experimental: Hypofractionation with SIB
Hypofractionated radiotherapy of the breast with simultaneous integrated boost to the tumor bed
Radiation: Hypofractionation with SIB
Hypofractionated radiotherapy of the breast with simultaneous integrated boost to the tumor bed




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 3 to 6 years ]
    any local or regional recurrence or distant metastasis or death


Secondary Outcome Measures :
  1. Time to occurence of local recurrence [ Time Frame: 3 to 6 years ]
    ipsilateral in-breast recurrence

  2. Overall survival [ Time Frame: 3 to 6 years ]
    death

  3. Safety and side effects (Number of Patients with Adverse Events) [ Time Frame: 3 to 6 years ]
    Number of Patients with Adverse Events

  4. Acute and chronic toxicity (NCI-CTCAE) [ Time Frame: 1 day, 7 days, end of radiation (last day of radiation and closing visite), 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months, 60 months, 66 months, 72 months ]
    All dimensions of NCI-CTCAE

  5. Cosmetic results (NCI-CTCAE) [ Time Frame: 1 day, end of radiation (last day of radiation and closing visite), 3 months, 12 months, 24 months, 36 months, 48 months, 60 months, 72 months ]
    NCI-CTCAE



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02474641


Locations
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Sponsors and Collaborators
University Hospital Schleswig-Holstein
University of Luebeck
Investigators
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Study Chair: Jürgen Dunst, MD University Medical Center Schleswig-Holstein (UKSH)
Publications:
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Responsible Party: Juergen Dunst, Prof., University Hospital Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT02474641    
Other Study ID Numbers: ARO-2013-05, ZKS-121-001
First Posted: June 18, 2015    Key Record Dates
Last Update Posted: August 25, 2021
Last Verified: August 2021
Keywords provided by Juergen Dunst, Prof., University Hospital Schleswig-Holstein:
Breast cancer
Hypofractionation with SIB
Non-inferiority
adjuvant radiotherapy with simultaneous integrated boost
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases