Status:
COMPLETED
Hypofractionated Radiotherapy Post-Lumpectomy in Women With Node Negative Breast Cancer
Lead Sponsor:
Ontario Clinical Oncology Group (OCOG)
Conditions:
Breast Cancer
Eligibility:
FEMALE
Phase:
NA
Brief Summary
To determine if hypofractionated radiotherapy to the whole breast (4,250 cGy/16 fractions over 22 days) is equally effective to standard fractionated radiotherapy (5,000 cGy/25 fractions over 35 days)...
Eligibility Criteria
Inclusion
- The female patient has a histological diagnosis of invasive carcinoma of the breast, and no evidence of metastatic disease.
- Has had a lumpectomy (including segmental resection and partial mastectomy), that is, surgical excision of the tumour with a rim of normal tissue.
- Patient has not had an axillary dissection, OR for patients who have had an axillary dissection, all nodes are negative for metastatic disease.
Exclusion
- Tumour greater than 5 cm in greatest diameter on pathological examination.
- The presence of invasive or intraductal (noninvasive) breast cancer involving the surgical margins.
- 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.
- Bilateral malignancy of the breast (synchronous or metachronous).
- More than one primary invasive tumour in the same breast.
- Previous surgery for breast cancer.
- Pathological status of axilla is unknown.
- Status for adjuvant systemic therapy not determined.
- For patients not treated with adjuvant chemotherapy: unable to commence radiation therapy within 16 weeks of last surgical procedure on the breast.
- For patients treated with adjuvant chemotherapy: unable to commence radiation therapy within 8 weeks of the last dose of chemotherapy.
- Serious nonmalignant disease (eg. cardiovascular, renal, etc.) which would preclude surgical or radiation treatment.
- Currently pregnant or lactating.
- Breast deemed too large to permit satisfactory radiation (ie. separation \> 25 cm).
- 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.
- Geographic inaccessibility for follow-up.
- Psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol.
Key Trial Info
Start Date :
April 1 1993
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
1234 Patients enrolled
Trial Details
Trial ID
NCT00156052
Start Date
April 1 1993
End Date
June 1 2015
Last Update
June 8 2015
Active Locations (11)
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1
Regional Cancer Program of the Sudbury Regional Hospital
Greater Sudbury, Ontario, Canada, P3E 5J1
2
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
3
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada, K7L 5P9
4
London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6