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Randomized Phase III Trial Comparing Intensity Modulated Radiotherapy With Integrated Boost to Conventional Radiotherapy With Consecutive Boost in Patients With Breast Cancer After Breast Conserving Surgery


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Randomized Phase III Trial Comparing Intensity Modulated Radiotherapy With Integrated Boost to Conventional Radiotherapy With Consecutive Boost in Patients With Breast Cancer After Breast Conserving Surgery


Inclusion Criteria:



- All patients aged >18 years and < 70 years after breast conserving surgery.

- Patients aged ≥ 70 years with following risk factors:

- Tumor stadium ≥ T2

- Multifocal disease

- Lymphangiosis

- Extended intraductal component

- Resection margin ≤3mm

Exclusion Criteria:

- Refusal of the patients to be included in the study

- Karnofsky Performance Score ≤ 70%

- Metastatic disease (M1)

- Other malignancies

- Previous radiotherapy of the breast

- Pregnancy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

cosmetic results

Outcome Description:

The cosmetic outcome will be assessed by two independent investigators using the Harvard criteria (excellent, good, fair, poor). Additional parameters to be evaluated are skin color, teleangiectasy, scars, shrinking and asymmetry. Evaluation will also be carried out using a quantitative digitizer scoring system based on standardized photodocumentations of the breast, as described by Vrieling et al.. by calculation of a breast retraction assessment (BRA) score.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Juergen Debus, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Heidelberg

Authority:

Germany: Federal Office for Radiation Protection

Study ID:

IMRT-MC2

NCT ID:

NCT01322854

Start Date:

March 2011

Completion Date:

March 2018

Related Keywords:

  • Breast Cancer
  • IMRT
  • Integrated boost
  • adjuvant radiotherapy
  • breast cancer
  • breast conserving surgery
  • Breast Neoplasms

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