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Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01948726
Recruitment Status : Completed
First Posted : September 24, 2013
Last Update Posted : August 26, 2021
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 with less lung toxicity in smaller studies.

Investigators initiated this multicenter phase II prospective trial to analyse acute toxicity of hypofractionation with simultaneous integrated boost in patients with early breast cancer under the hypothesis that the ratio of patients with acute radiogenic toxicity Grad II according NCI-CTCAE amounts maximum 20%.

Condition or disease Intervention/treatment Phase
Breast Cancer After Breast Conserving Surgery Indicating Postoperative Radiotherapy With Boost Radiation: Hypofractionation with simultaneous integrated boost Not Applicable

Detailed Description:
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 : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Phase-II-Trial of Evaluation of Acute Toxicity in Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer
Study Start Date : December 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Hypofractionation with SIB Radiation: Hypofractionation with simultaneous integrated boost

Primary Outcome Measures :
  1. Acute Skin Toxicity [ Time Frame: 6 months ]
    Acute skin radiogenic toxicity grade II or higher according to NCI-CTCAE

Secondary Outcome Measures :
  1. Number of Patients treated on Protocol [ Time Frame: 22-29 days (16 fractions) ]
    Dose constraints Dmedian lung < 10 Gy; Dmedian heart < 5 Gy, Dmax ≤ 40 Gy; Dmedian anterior branch of the left coronary artery (LAD, RIVA) < 15 Gy, Dmax ≤ 40 Gy; Dmedian contralateral breast < 3 Gy

  2. Acute General Toxicity [ Time Frame: 0 to 6 months ]
    All dimensions of NCI-CTCAE

  3. Quality of life Score [ Time Frame: 0 to 6 months ]
    EORTC QLQ-C30, -BR23

  4. Performance [ Time Frame: 0 to 6 months ]

Other Outcome Measures:
  1. Skin toxicity (Cosmetic results) [ Time Frame: 0 to 6 months ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Histopathologically confirmed breast cancer operated by breast conserving surgery with clear margins
  • 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
  • Pre- and/or postoperative chemotherapy and endocrine therapy were permitted when indicated
  • Written informed consent

Exclusion Criteria:

  • Patients operated by mastectomy
  • No indication for boost radiation
  • 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
  • Psychiatric disorders or psychological disabilities thought to adversely affect treatment compliance
  • Pregnant or lactating patients and woman of child bearing potential, who lacked effective contraception

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 identifier (NCT number): NCT01948726

Show Show 19 study locations
Sponsors and Collaborators
University Hospital Schleswig-Holstein
University of Luebeck
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Study Chair: Juergen Dunst, Prof. University Medical Center Schleswig-Holstein (UKSH)
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Responsible Party: Juergen Dunst, Prof., Prof. Dr. med. Juergen Dunst, University Hospital Schleswig-Holstein Identifier: NCT01948726    
Other Study ID Numbers: ARO 2013-04
First Posted: September 24, 2013    Key Record Dates
Last Update Posted: August 26, 2021
Last Verified: August 2021
Keywords provided by Juergen Dunst, Prof., University Hospital Schleswig-Holstein:
Breast cancer
Simultaneous integrated boost
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases