None listed
Conditions
Brief summary
Radiotherapy to the breast reduces the risk of cancer coming back for women with early breast cancer. This international study will determine if treating a larger area with radiotherapy can further improve the results.
Interventions
Arm 2: Breast radiation plus regional radiation. A dose of 5000cGy in 25 fractons at a rate of 200cGy per day, five days a week for five weeks will be prescribed to the modified wide tangent fields (the upper 1st and 3rd interspace ipsilateral internal mammary, superclavicular and axillary nodes).
Sponsors
National Cancer Institute of Canada (NCIC)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Histologically proven invasive carcinoma of the breast and no evidence of metastatic disease.- Investigations, including ER receptor status, and chest x-ray, and any additional investigations to rule out metastatic disease performed within 9 months prior to randomization.- A history and physical exam including weight, performance status and measurement of upper andlower arm circumferences performed within 12 weeks prior to randomization.- A bilateral mammogram performed within 12 months prior to randomization.- Patients must have been treated with Breast conservation therapy (BCT) (eg. lumpectomy, partial mastectomy, or segmental mastectomy) and axillary node dissection or sentinel node biopsy and considered a candidate for breast radiation. - Patients must be at high risk of regional recurrence, due to 1) pathologically positive axillary nodes, or2) pathologically negative axillary nodes anda) primary tumor > 5 cm orb) primary tumor > 2 cm and <10 axillary nodes removed and one of the following: ER negative, Skarf-Bloom-Richardson (SBR) grade 3 or lymphovascular invasion.Note: Patients with sentinel node dissection are eligible if they are node negative but still meet thehigh risk criteria. However, if they are node positive, a level I and II axillary dissection must be performed.- Patients must be treated with adjuvant systemic treatment, either currently accepted chemotherapy and/or hormonal therapy. (Patients may also have planned chemotherapy concurrently with theirradiation therapy.)- Performance status must be Eastern Cooperative Onocology Group (ECOG) 0, 1, or 2.- Patients should be planned and started on radiation as soon as possible after randomization.- Protocol treatment (radiotherapy) must begin within 8 weeks of the completion of adjuvant chemotherapy, unless radiotherapy is given concurrently with chemotherapy (ie CMF), or within 16weeks of the last surgical procedure for patients receiving hormonal therapy only.Patient’s life expectancy is >5 years- Women of childbearing potential must be using adequate contraception while receiving radiotherapy.
Exclusion criteria
Clinical evidence prior to surgery of T4 or N2-3 disease (UICC, 1997)- Evidence of residual disease in the axilla following dissection.- Serious non-malignant disease (e.g., cardiovascular, renal, pulmonary, systemic lupus erythematosis-SLE, scleroderma) which would preclude definitive surgical or radiation treatment.Note: Radiation therapy may not be recommended for patients with connective tissue disorders such as Lupus or Scleroderma.- Currently pregnant or lactating.- Women of childbearing age must be using adequate contraception while on treatment.- Concurrent and previous malignancies except non melanoma skin cancer; carcinoma in situ of the cervix or endometrium; contralateral non-invasive breast cancer (unless previous radiation to the contralateral breast). Also, invasive carcinoma of the cervix, endometrium, colon, thyroid, and melanoma treated five years prior to study entry and presumed cured are permitted on study.- Psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol.
Outcome results
None listed