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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 February 2013 |
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Main ID: |
NCT00156052 |
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Date of registration:
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08/09/2005 |
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Primary sponsor: |
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Public title:
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Hypofractionated Radiotherapy Post-Lumpectomy in Women With Node Negative Breast Cancer
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Scientific title:
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A Randomized Trial of Hypofractionated Radiotherapy Post-Lumpectomy in Women With Node Negative Breast Cancer |
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Date of first enrolment:
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April 1993 |
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Target sample size:
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1234 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00156052 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Canada
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Contacts
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Name:
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Tim Whelan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Juravinski Cancer Centre |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. The female patient has a histological diagnosis of invasive carcinoma of the breast,
and no evidence of metastatic disease.
2. Has had a lumpectomy (including segmental resection and partial mastectomy), that is,
surgical excision of the tumour with a rim of normal tissue.
3. Patient has not had an axillary dissection, OR for patients who have had an axillary
dissection, all nodes are negative for metastatic disease.
Exclusion Criteria:
1. Tumour greater than 5 cm in greatest diameter on pathological examination.
2. The presence of invasive or intraductal (noninvasive) breast cancer involving the
surgical margins.
3. Clinical evidence prior to surgery of infiltration of the skin of the involved breast
such as edema, ulceration, or fixation of the tumour to underlying muscle, or
inflammatory breast cancer.
4. Bilateral malignancy of the breast (synchronous or metachronous).
5. More than one primary invasive tumour in the same breast.
6. Previous surgery for breast cancer.
7. Pathological status of axilla is unknown.
8. Status for adjuvant systemic therapy not determined.
9. For patients not treated with adjuvant chemotherapy: unable to commence radiation
therapy within 16 weeks of last surgical procedure on the breast.
10. For patients treated with adjuvant chemotherapy: unable to commence radiation
therapy within 8 weeks of the last dose of chemotherapy.
11. Serious nonmalignant disease (eg. cardiovascular, renal, etc.) which would preclude
surgical or radiation treatment.
12. Currently pregnant or lactating.
13. Breast deemed too large to permit satisfactory radiation (ie. separation > 25 cm).
14. Previous concomitant malignancies of any type except squamous, or basal cell
carcinomas of the skin, or carcinoma \fIin situ\fR of the cervix which have been
effectively treated.
15. Geographic inaccessibility for follow-up.
16. Psychiatric or addictive disorders which preclude obtaining informed consent or
adherence to the protocol.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Intervention(s)
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Radiation: Conventional whole breast radiation schedule
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Radiation: Hypofractionated whole breast radiation schedule
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Primary Outcome(s)
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Local breast recurrence
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Secondary Outcome(s)
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Cost effectiveness
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Morbidity
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Secondary ID(s)
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OCOG-1993-hypo
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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