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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Helical tomotherapy | Experimental | Helical tomotherapy IMRT 50 Gy in 25 fractions, daily treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Helical tomotherapy IMRT | Procedure | Helical tomotherapy IMRT 50 Gy in 25 fractions, daily treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute Radiation Effects (Less Than 90 Days Post Treatment) | Grade 3 or higher radiation effects(less than 90 days post treatment) | less than 90 days post treatment |
| Moderate-late Pulmonary and Cardiac Radiation Effects | Grade 3 or higher moderate-late pulmonary and cardiac radiation effects up to 1 year post radiation | up to 1 year post radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Local Recurrence | Evaluate rate of local recurrence at 5 years | 5 years |
| Rate of Regional Recurrence | Evaluate rate of regional recurrence at 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Michel Caudrelier, md | OHRI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital Regional Cancer Centre | Ottawa | Ontario | K1H 8L6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25052720 | Derived | Caudrelier JM, Meng J, Esche B, Grimard L, Ruddy T, Amjadi K. IMRT sparing of normal tissues in locoregional treatment of breast cancer. Radiat Oncol. 2014 Jul 22;9:161. doi: 10.1186/1748-717X-9-161. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Helical Tomotherapy | Helical tomotherapy IMRT: Helical tomotherapy IMRT 50 Gy in 25 fractions, daily treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Helical Tomotherapy | Helical tomotherapy IMRT: Helical tomotherapy IMRT 50 Gy in 25 fractions, daily treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acute Radiation Effects (Less Than 90 Days Post Treatment) | Grade 3 or higher radiation effects(less than 90 days post treatment) | Posted | Count of Participants | Participants | less than 90 days post treatment |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Helical Tomotherapy | Helical tomotherapy IMRT: Helical tomotherapy IMRT 50 Gy in 25 fractions, daily treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Distant Recurrent Disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jean-Michel Caudrelier | Ottawa Hospital Research Institute | 613-737-8899 | 70216 | jcaudrelier@toh.ca |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| 5 years |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Moderate-late Pulmonary and Cardiac Radiation Effects | Grade 3 or higher moderate-late pulmonary and cardiac radiation effects up to 1 year post radiation | Posted | Count of Participants | Participants | up to 1 year post radiation |
|
|
|
| Secondary | Rate of Local Recurrence | Evaluate rate of local recurrence at 5 years | Posted | Count of Participants | Participants | 5 years |
|
|
|
| Secondary | Rate of Regional Recurrence | Evaluate rate of regional recurrence at 5 years | Posted | Count of Participants | Participants | 5 years |
|
|
|
| 6 |
| 30 |
| 5 |
| 30 |
| 0 |
| 30 |
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