Adjuvant Whole Breast Radiotherapy (RT) With Intensity Modulated Radiotherapy (IMRT) and a Simultaneous Integrated Boost Versus Conventional RT and a Sequential Boost (IMRT-MC2)

Heidelberg University

Status and phase: Unknown; Phase 3

Conditions: Breast Cancer

Treatments: Radiation: IMRT with an simultaneous integrated boost

Study type: Interventional

Funder types: Other

Identifiers

NCT01322854

IMRT-MC2

Details and patient eligibility

About

The IMRT-MC2 study is a prospective, two armed, multicenter, 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. 502 patients will be recruited and randomized in two arms: patients in arm A will receive IMRT in 28 fractions delivering 50.4 Gy to the breast and 64.4 Gy to the tumor-bed by an integrated boost, while patients in arm B will receive conventional radiotherapy of the breast in 28 fractions to a dose of 50.4 Gy and a consecutive boost in 8 fractions to a total dose of 66.4 Gy. Primary aim of the study is the assessment of the cosmetic outcome and local control after breast radiotherapy. The study hypothesis is that intensity modulated radiotherapy (IMRT) is, in spite of the reduced treatment duration, at least equivalent to conventional therapy.

Enrollment: 502 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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502 participants in 2 patient groups

IMRT + integrated boost

Experimental group

Description:

28 fractions delivering 50.4 Gy to the whole breast and 64.4 Gy to the tumor-bed by an integrated boost

Treatment:

Radiation: IMRT with an simultaneous integrated boost

Conventional RT + sequential boost

Other group

Description:

Conventional radiotherapy of the whole breast in 28 fractions to a dose of 50.4 Gy and a consecutive boost in 8 fractions to a total dose of 66.4 Gy

Treatment:

Radiation: IMRT with an simultaneous integrated boost