Hypofractionated Radiotherapy Post-Lumpectomy in Women With Node Negative Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Radiation: Hypofractionated whole breast radiation schedule; Radiation: Conventional whole breast radiation schedule

• Registration Number: NCT00156052
• Lead Sponsor: Ontario Clinical Oncology Group (OCOG)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1993-04
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Status Verified: 2015-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Last Update Submitted: 2015-06-03
• Last Update Posted: 2015-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1234

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypofractionated whole breast radiation	Hypofractionated whole breast radiation schedule	Subjects treated with 4250 cGY in 16 fractions
Conventional whole breast radiation	Conventional whole breast radiation schedule	Subjects treated with 5000 cGY in 25 fractions

Primary Outcome Measures

Name	Time	Method
Local breast recurrence	Indefinitely

Secondary Outcome Measures

Name	Time	Method
Morbidity	Indefinitely
Cost effectiveness	Indefinitely

Trial Locations

Locations (11)

Juravinski Cancer Centre; 🇨🇦 Hamilton, Ontario, Canada

Cancer Centre of Southeastern Ontario at Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada

Regional Cancer Care - Thunder Bay HSC; 🇨🇦 Thunder Bay, Ontario, Canada

Ottawa Hospital-Integrated Cancer Program; 🇨🇦 Ottawa, Ontario, Canada

Toronto Sunnybrook Regional Cancer Centre; 🇨🇦 Toronto, Ontario, Canada

The Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

Windsor Regional Cancer Centre; 🇨🇦 Windsor, Ontario, Canada

Montreal General Hospital; 🇨🇦 Montreal, Quebec, Canada

London Regional Cancer Centre; 🇨🇦 London, Ontario, Canada

Niagara Health System; 🇨🇦 St. Catharines, Ontario, Canada

Regional Cancer Program of the Sudbury Regional Hospital; 🇨🇦 Sudbury, Ontario, Canada