Comparison of the Cosmetic Outcome of Hypofractionated Versus Normofractionated IMRT in Treatment of Breast Cancer (KOSIMA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Universitätsmedizin Mannheim.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier:
NCT01403779
First received: October 29, 2010
Last updated: July 26, 2011
Last verified: October 2010
  Purpose

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 Intervention Phase
Tumors
Breast Cancer
Radiation: intensity modulated radiotherapy (IMRT) for breast cancer
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Universitätsmedizin Mannheim:

Primary Outcome Measures:
  • acute and chronic cosmetic outcome [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • acute and chronic cosmetic outcome, Quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 226
Study Start Date: July 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01403779

Contacts
Contact: Frederik Wenz, MD +496213834960 frederik.wenz@medma.uni-heidelberg.de
Contact: Ahmed Yasser Abou-Madian, MD +496213836020 yasser.abomadyan@umm.de

Locations
Germany
Department of Radiotherapy University Hospital Mannheim Recruiting
Mannheim, Germany, 68167
Contact: Frederik Wenz, Prof. Dr. med.    00496213834960    frederik.wenz@medma.uni-heidelberg.de   
Principal Investigator: Frederik Wenz, MD         
Sub-Investigator: Ahmed Yasser Abou-Madian, MD         
Sponsors and Collaborators
Universitätsmedizin Mannheim
Investigators
Study Chair: Frederik Wenz, MD UMM
  More Information

No publications provided

Responsible Party: Prof. Dr. med. F. Wenz, Department of Radiation Oncology
ClinicalTrials.gov Identifier: NCT01403779     History of Changes
Other Study ID Numbers: MA-KOSIMA-01
Study First Received: October 29, 2010
Last Updated: July 26, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Universitätsmedizin Mannheim:
Intensity-Modulated Radiation Therapy (IMRT)
Breast cancer
Hypofractionation

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 28, 2014