The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
NCT Number: NCT00508352
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Ottawa, Ontario, K1H 8L6, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Helical tomotherapy IMRT 50 Gy in 25 fractions, daily treatment
Time frame: less than 90 days post treatment
Grade 3 or higher radiation effects(less than 90 days post treatment)
Time frame: up to 1 year post radiation
Grade 3 or higher moderate-late pulmonary and cardiac radiation effects up to 1 year post radiation
Time frame: 5 years
Evaluate rate of local recurrence at 5 years
Time frame: 5 years
Evaluate rate of regional recurrence at 5 years
Ottawa Hospital Research Institute
Other
Post-operative Locoregional Irradiation Using Helical Tomotherapy IMRT in the Management of Stage IIb-III Breast Cancer: a Feasibility Study
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