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NCT Number: NCT01948726

Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer

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%.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Charité University Medical Center Berlin, Berlin, Germany

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypofractionation with simultaneous integrated boost

Radiation

Primary outcomes

  1. Acute Skin Toxicity

    Time frame: 6 months

    Acute skin radiogenic toxicity grade II or higher according to NCI-CTCAE

Secondary outcomes

  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

    ECOG

Other outcomes

  1. Skin toxicity (Cosmetic results)

    Time frame: 0 to 6 months

    NCI-CTCAE

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Collaborators

  • University of Luebeck

Registry information

Official study title

Multicenter Phase-II-Trial of Evaluation of Acute Toxicity in Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 24, 2013
Registry last updated
Aug 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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