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Comparison of the Cosmetic Outcome of Hypofractionated Versus Normofractionated Intensity Modulated Radiotherapy (IMRT) in Treatment of Breast Cancer: The KOSIMA Trial


Phase 3
60 Years
N/A
Open (Enrolling)
Female
Tumors, Breast Cancer

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Trial Information

Comparison of the Cosmetic Outcome of Hypofractionated Versus Normofractionated Intensity Modulated Radiotherapy (IMRT) in Treatment of Breast Cancer: The KOSIMA Trial


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

acute and chronic cosmetic outcome

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Frederik Wenz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UMM

Authority:

Germany: Ethics Commission

Study ID:

MA-KOSIMA-01

NCT ID:

NCT01403779

Start Date:

July 2010

Completion Date:

July 2012

Related Keywords:

  • Tumors
  • Breast Cancer
  • Intensity-Modulated Radiation Therapy (IMRT)
  • Breast cancer
  • Hypofractionation
  • Breast Neoplasms

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