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Trial record 1 of 1 for:    NCT01403779
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Comparison of the Cosmetic Outcome of Hypofractionated Versus Normofractionated IMRT in Treatment of Breast Cancer (KOSIMA)

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ClinicalTrials.gov Identifier: NCT01403779
Recruitment Status : Completed
First Posted : July 27, 2011
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Frederik Wenz, Universitätsmedizin Mannheim

Tracking Information
First Submitted Date  ICMJE October 29, 2010
First Posted Date  ICMJE July 27, 2011
Last Update Posted Date January 23, 2019
Study Start Date  ICMJE July 2010
Actual Primary Completion Date February 2, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2011)
acute and chronic cosmetic outcome [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2011)
acute and chronic cosmetic outcome, Quality of life [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of the Cosmetic Outcome of Hypofractionated Versus Normofractionated IMRT in Treatment of Breast Cancer
Official Title  ICMJE Comparison of the Cosmetic Outcome of Hypofractionated Versus Normofractionated Intensity Modulated Radiotherapy (IMRT) in Treatment of Breast Cancer: The KOSIMA Trial
Brief Summary

Several multicenter studies have shown the equivalence of hypofractionated radiotherapy and normofractionated radiotherapy after breast-conserving surgery. However, the treatment in these studies was carried out with conventional techniques and not with the modern IMRT. Also the evaluation of quality of life and cosmetic outcome were not standardized.

This study is a two-arm prospective study comparing normofractionated and hypofractionated radiotherapy in patients with breast cancer using tangential IMRT techniques.

The primary endpoints are acute and chronic cosmetic breast changes. The secondary endpoint is the patients' quality of life.

Patients to be included are breast cancer 60 years old patients or older with tumour stages pTis-pT3, pN0-pN1a, M0 after breast-conserving surgery. Patients with right sided breast cancer are stratified to receive a hypofractionated treatment course (40.05 / 2.67Gy in 15 fractions) and the left sided breast cancer a normofractionated irradiation (50/2Gy in 25 fractions). In both arms, patients between 60-69 years are to receive a boost (16 Gy / 2Gy).

In both groups, a tangential intensity-modulated radiation technique aiming to achieve optimal dose homogeneity is applied.

Since higher single radiation dose to the heart can lead to higher morbidity and/or mortality, patient stratification according to the diseased side was adopted where the left-sided breast cancer patients would receive normofractionated 2Gy single dose. Therefore there is no randomization.

For classification and grading of adverse cosmetic events, the "Common Toxicity Criteria (CTC-AE V3.0) and the recognized LENT-SOMA scores are to be regularly documented. Quality of life is to be documented with two standardized, validated questionnaires "QLQ C30 and BR23" of the EORTC (European Organization for Research and Treatment of Cancer). The questionnaires are to be filled by the patients themselves at different time points during the study period.

A sum of grade III fibrosis, grade III telangiectasia and grade II hyperpigmentation of around 20% is expected after 2 years.

Therefore, calculation of the required number of cases based on an alpha of 0.05 and a power of 80% with a maximal tolerable toxicity difference of 15% within 2 years results in the need for recruiting 226 patients (113 in each arm) (non-inferiority of hypofractionated therapy).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Tumors
  • Breast Cancer
Intervention  ICMJE Radiation: intensity modulated radiotherapy (IMRT) for breast cancer
right sided breast cancer patients are stratified to receive a hypofractionated treatment course (40.05 / 2.67Gy in 15 fractions) and the left sided breast cancer patients a normofractionated irradiation (50/2Gy in 25 fractions). In both arms, patients between 60-69 years are to receive a boost (16 Gy / 2Gy).
Other Name: Arm 1, Arm 2
Study Arms  ICMJE
  • Active Comparator: 1-Hypofractionated IMRT
    hypofractionated IMRT for right sided breast cancer
    Intervention: Radiation: intensity modulated radiotherapy (IMRT) for breast cancer
  • Active Comparator: 2-Normofractioated IMRT
    normofractionated IMRT for left sided breast cancer
    Intervention: Radiation: intensity modulated radiotherapy (IMRT) for breast cancer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 26, 2011)
226
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2, 2017
Actual Primary Completion Date February 2, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed invasive or in situ breast cancer, tumor stage pTis-pT3, pN0-1a, M0
  • Age ≥ 60 years
  • signed informed consent from the patient

Exclusion Criteria:

  • Stage pN1b-PN3, pT4 and / or M1
  • incomplete surgical resection
  • after mastectomy of the ipsilateral or contralateral breast
  • breast reconstruction with implant or expander insert
  • bilateral breast cancer
  • Lack of compliance or consent
  • Indications for irradiation of the axillary, supraclavicular or parasternal lymph nodes
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01403779
Other Study ID Numbers  ICMJE MA-KOSIMA-01
ARO 2010-3 ( Other Identifier: Arbeitsgemeinschaft Radiologische Onkologie der Deutschen Krebsgesellschaft )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Frederik Wenz, Universitätsmedizin Mannheim
Original Responsible Party Prof. Dr. med. F. Wenz, Department of Radiation Oncology
Current Study Sponsor  ICMJE Universitätsmedizin Mannheim
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Frederik Wenz, MD UMM
PRS Account Universitätsmedizin Mannheim
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP