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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00156052
• Other study ID #: OCOG-1993-hypo
• Status: Completed
• Phase: N/A
• First received: September 8, 2005
• Last updated: June 3, 2015
• Start date: April 1993
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Ontario Clinical Oncology Group (OCOG)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1234
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• Conventional whole breast radiation schedule

• Hypofractionated whole breast radiation schedule

Locations

Country	Name	City	State
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	Cancer Centre of Southeastern Ontario at Kingston General Hospital	Kingston	Ontario
Canada	London Regional Cancer Centre	London	Ontario
Canada	Montreal General Hospital	Montreal	Quebec
Canada	Ottawa Hospital-Integrated Cancer Program	Ottawa	Ontario
Canada	Niagara Health System	St. Catharines	Ontario
Canada	Regional Cancer Program of the Sudbury Regional Hospital	Sudbury	Ontario
Canada	Regional Cancer Care - Thunder Bay HSC	Thunder Bay	Ontario
Canada	The Princess Margaret Hospital	Toronto	Ontario
Canada	Toronto Sunnybrook Regional Cancer Centre	Toronto	Ontario
Canada	Windsor Regional Cancer Centre	Windsor	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ontario Clinical Oncology Group (OCOG)

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Whelan T, MacKenzie R, Julian J, Levine M, Shelley W, Grimard L, Lada B, Lukka H, Perera F, Fyles A, Laukkanen E, Gulavita S, Benk V, Szechtman B. Randomized trial of breast irradiation schedules after lumpectomy for women with lymph node-negative breast — View Citation

Whelan TJ, Pignol JP, Levine MN, Julian JA, MacKenzie R, Parpia S, Shelley W, Grimard L, Bowen J, Lukka H, Perera F, Fyles A, Schneider K, Gulavita S, Freeman C. Long-term results of hypofractionated radiation therapy for breast cancer. N Engl J Med. 2010 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local breast recurrence		Indefinitely	No
Secondary	Morbidity		Indefinitely	No
Secondary	Cost effectiveness		Indefinitely	No