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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

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).


Condition or disease Intervention/treatment Phase
Tumors Breast Cancer Radiation: intensity modulated radiotherapy (IMRT) for breast cancer Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 226 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of the Cosmetic Outcome of Hypofractionated Versus Normofractionated Intensity Modulated Radiotherapy (IMRT) in Treatment of Breast Cancer: The KOSIMA Trial
Study Start Date : July 2010
Actual Primary Completion Date : February 2, 2017
Actual Study Completion Date : February 2, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1-Hypofractionated IMRT
hypofractionated IMRT for right sided breast cancer
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

Active Comparator: 2-Normofractioated IMRT
normofractionated IMRT for left sided breast cancer
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




Primary Outcome Measures :
  1. acute and chronic cosmetic outcome [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. acute and chronic cosmetic outcome, Quality of life [ Time Frame: 2 years ]


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01403779


Locations
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Germany
Department of Radiotherapy University Hospital Mannheim
Mannheim, Germany, 68167
Sponsors and Collaborators
Universitätsmedizin Mannheim
Investigators
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Study Chair: Frederik Wenz, MD UMM

Additional Information:
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Responsible Party: Frederik Wenz, Prof. Dr., Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier: NCT01403779     History of Changes
Other Study ID Numbers: MA-KOSIMA-01
ARO 2010-3 ( Other Identifier: Arbeitsgemeinschaft Radiologische Onkologie der Deutschen Krebsgesellschaft )
First Posted: July 27, 2011    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Keywords provided by Frederik Wenz, Universitätsmedizin Mannheim:
Intensity-Modulated Radiation Therapy (IMRT)
Breast cancer
Hypofractionation
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases