Post-operative Radiation With IMRT in the Management of Stage IIB-III Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00508352
Recruitment Status : Completed
First Posted : July 27, 2007
Last Update Posted : June 3, 2013
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:
Research has shown that treatment with conventional radiation techniques and chemotherapy following mastectomy or breast conserving surgery has resulted in better rates of locoregional control and overall survival in stage IIB-III breast cancer. The current feasibility trial using the most recent advance in radiation therapy, namely helical tomotherapy intensity modulated radiation therapy (HT-IMRT), hopes to improve on the results of conventional radiation by decreasing the amount of radiation-induced toxicity in patients with stage IIb-III breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Helical tomotherapy IMRT Phase 1 Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post-operative Locoregional Irradiation Using Helical Tomotherapy IMRT in the Management of Stage IIb-III Breast Cancer: a Feasibility Study
Study Start Date : January 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Helical tomotherapy
Helical tomotherapy IMRT 50 Gy in 25 fractions, daily treatment
Procedure: Helical tomotherapy IMRT
Helical tomotherapy IMRT 50 Gy in 25 fractions, daily treatment

Primary Outcome Measures :
  1. Acute radiation effects(less than 90 days post treatment) [ Time Frame: less than 90 days post treatment ]
  2. Moderate-late pulmonary and cardiac radiation effects [ Time Frame: up to 1 year post radiation ]

Secondary Outcome Measures :
  1. Rate of local recurrence [ Time Frame: 5 years ]
  2. Rate of regional recurrence [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 therapy
  4. ECOG performance status of 2 or less

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00508352

Canada, Ontario
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Principal Investigator: Jean-Michel Caudrelier, md OHRI

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ottawa Hospital Research Institute Identifier: NCT00508352     History of Changes
Other Study ID Numbers: 2006277-01H
First Posted: July 27, 2007    Key Record Dates
Last Update Posted: June 3, 2013
Last Verified: May 2013

Keywords provided by Ottawa Hospital Research Institute:

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