A Randomized Trial of Hypofractionated Radiotherapy Post-Lumpectomy in Women With Node Negative Breast Cancer

Ontario Clinical Oncology Group (OCOG)11 sites in 1 country1,234 target enrollmentApril 1993

ConditionsBreast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Ontario Clinical Oncology Group (OCOG)
Enrollment: 1234
Locations: 11
Primary Endpoint: Local breast recurrence
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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) in women with node negative breast cancer who have undergone lumpectomy.

The primary outcome is local breast recurrence and secondary outcomes include morbidity and cost effectiveness.

Registry

clinicaltrials.gov

Start Date

April 1993

End Date

June 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Ontario Clinical Oncology Group (OCOG)

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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.