Breast Cancer
Conditions
Keywords
breast, cancer, locoregional, IMRT, tomotherapy
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.
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.
Interventions
PROCEDUREHelical tomotherapy IMRT
Helical tomotherapy IMRT 50 Gy in 25 fractions, daily treatment
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Radiation Effects (Less Than 90 Days Post Treatment) | less than 90 days post treatment | Grade 3 or higher radiation effects(less than 90 days post treatment) |
| Moderate-late Pulmonary and Cardiac Radiation Effects | up to 1 year post radiation | Grade 3 or higher moderate-late pulmonary and cardiac radiation effects up to 1 year post radiation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Local Recurrence | 5 years | Evaluate rate of local recurrence at 5 years |
| Rate of Regional Recurrence | 5 years | Evaluate rate of regional recurrence at 5 years |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Helical Tomotherapy Helical tomotherapy IMRT: Helical tomotherapy IMRT 50 Gy in 25 fractions, daily treatment | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Helical Tomotherapy | — |
|---|---|---|
| Age, Continuous | 52 Years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 30 participants | — |
| Sex: Female, Male Female | 30 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 5 / 30 |
Outcome results
Primary
Acute Radiation Effects (Less Than 90 Days Post Treatment)
Grade 3 or higher radiation effects(less than 90 days post treatment)
Time frame: less than 90 days post treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Helical Tomotherapy | Acute Radiation Effects (Less Than 90 Days Post Treatment) | 0 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
Time frame: up to 1 year post radiation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Helical Tomotherapy | Moderate-late Pulmonary and Cardiac Radiation Effects | 0 Participants |
Secondary
Rate of Local Recurrence
Evaluate rate of local recurrence at 5 years
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Helical Tomotherapy | Rate of Local Recurrence | 0 Participants |
Secondary
Rate of Regional Recurrence
Evaluate rate of regional recurrence at 5 years
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Helical Tomotherapy | Rate of Regional Recurrence | 0 Participants |