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Post-operative Locoregional Irradiation Using Helical Tomotherapy IMRT in the Management of Stage IIb-III Breast Cancer: a Feasibility Study

Phase 1/Phase 2
18 Years
Not Enrolling
Breast Cancer

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Trial Information

Post-operative Locoregional Irradiation Using Helical Tomotherapy IMRT in the Management of Stage IIb-III Breast Cancer: a Feasibility Study

The role of locoregional radiation therapy in the management of stage IIB and III breast
cancer has evolved and continues to evolve. The exact role of locoregional radiation,
including axillary, supraclavicular and internal mammary nodes is, however, not clear.
Radiation-induced toxicity remains a limiting factor to expanding the indications for
radiation therapy to axillary and internal mammary nodes in the treatment of stage IIB and
III breast cancer. Excellent target coverage and normal tissue sparing of IMRT has been
previously demonstrated dosimetrically and clinically. In this feasibility study, patients
will receive 50 Gy of radiation therapy in 25 fractions to the chest wall and
supraclavicular, axillary and IM nodal areas using HT-IMRT following breast conserving
surgery or mastectomy and chemotherapy. Patients will also be eligible for a radiation
boost to 12 Gy by HT-IMRT or HDR brachytherapy. It is expected that treatment with HT-IMRT
will result in appreciably fewer side-effects following locoregional irradiation due to a
reduction in normal tissue irradiation, as compared to conventional radiation therapy.

Inclusion Criteria:

1. Surgery with either mastectomy or breast conserving surgery

2. Presence and association of any of the following high risk pathological features
present at time of surgery: stage pT3-4 and pN0 and central/medial location of tumour
or any pT and pN2 (stage IIB-stage III)

3. All patients will have been treated previously with chemotherapy prior to radiation

4. ECOG performance status of 2 or less

Exclusion Criteria:

1. Prior chest wall/breast or nodal radiation for other malignancies (i.e. Hodgkin

2. HER2+ positive patients

3. Patients with diagnosis of metastatic disease

4. Prior or active malignancy except non-melanoma skin carcinoma within 5 years of the
diagnosis of breast cancer

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Acute radiation effects(less than 90 days post treatment)

Outcome Time Frame:

less than 90 days post treatment

Safety Issue:


Principal Investigator

Jean-Michel Caudrelier, md

Investigator Role:

Principal Investigator

Investigator Affiliation:



Canada: Health Canada

Study ID:




Start Date:

January 2007

Completion Date:

October 2009

Related Keywords:

  • Breast Cancer
  • breast
  • cancer
  • locoregional
  • IMRT
  • tomotherapy
  • Breast Neoplasms