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

NCT00156052 | Completed

• 1 other identifier: OCOG-1993-hypo
• Study Type: interventional
• Target: 1,234
• Locations: 1 country
• Sites: 11

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Hypofractionated Radiotherapy; Lumpectomy

Outcome Measures

Primary Outcomes (1)

• Local breast recurrence

  Indefinitely

Secondary Outcomes (2)

• Morbidity

  Indefinitely

• Cost effectiveness

  Indefinitely

Study Arms (2)

Hypofractionated whole breast radiation

EXPERIMENTAL

Subjects treated with 4250 cGY in 16 fractions

Radiation: Hypofractionated whole breast radiation schedule

Conventional whole breast radiation

ACTIVE COMPARATOR

Subjects treated with 5000 cGY in 25 fractions

Radiation: Conventional whole breast radiation schedule

Interventions

Conventional whole breast radiation schedule RADIATION

Conventional whole breast radiation

Hypofractionated whole breast radiation schedule RADIATION

Hypofractionated whole breast radiation

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ontario Clinical Oncology Group (OCOG): lead

Study Sites (11)

Regional Cancer Program of the Sudbury Regional Hospital

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Kingston, Ontario, K7L 5P9, Canada

Location

London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Ottawa Hospital-Integrated Cancer Program

Ottawa, Ontario, K1H 1C4, Canada

Location

Niagara Health System

St. Catharines, Ontario, L2R 5K3, Canada

Location

Regional Cancer Care - Thunder Bay HSC

Thunder Bay, Ontario, P7B 6V4, Canada

Location

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

The Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Windsor Regional Cancer Centre

Windsor, Ontario, N8W 2X3, Canada

Location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Related 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 cancer. J Natl Cancer Inst. 2002 Aug 7;94(15):1143-50. doi: 10.1093/jnci/94.15.1143.

  PMID: 12165639 RESULT

• 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 Feb 11;362(6):513-20. doi: 10.1056/NEJMoa0906260.

  PMID: 20147717 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Tim Whelan, MD

  Juravinski Cancer Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: April 1, 1993
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 8, 2015

Record last verified: 2015-06

Locations

CA (11)