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Sponsored by: |
Ottawa Health Research Institute |
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Information provided by: | Ottawa Health Research Institute |
ClinicalTrials.gov Identifier: | 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.
Condition | Intervention | Phase |
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Breast Cancer |
Procedure: Helical tomotherapy IMRT |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Post-Operative Locoregional Irradiation Using Helical Tomotherapy IMRT in the Management of Stage IIb-III Breast Cancer: a Feasibility Study |
Estimated Enrollment: | 30 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | January 2010 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
The Ottawa Hospital Regional Cancer Centre | Recruiting |
Ottawa, Ontario, Canada, K1H 8L6 | |
Contact: Pamela Cogan 613-737-7700 ext 79767 pcogan@ohri.ca | |
Contact: Scott Grimes 613-737-7700 ext 70523 sgrimes@ohri.ca | |
Principal Investigator: Jean-Michel Caudrelier, MD |
Principal Investigator: | Jean-Michel Caudrelier, md | OHRI |
Study ID Numbers: | 2006277-01H, OTT 06-03 |
Study First Received: | July 25, 2007 |
Last Updated: | July 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00508352 |
Health Authority: | Canada: Health Canada |
breast cancer locoregional IMRT tomotherapy |
Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |