Hypofractionated Radiotherapy Post-Lumpectomy in Women With Node Negative Breast Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Ontario Clinical Oncology Group (OCOG)
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:
NCT00156052
First received: September 8, 2005
Last updated: January 28, 2013
Last verified: July 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Radiation: Conventional whole breast radiation schedule Radiation: Hypofractionated whole breast radiation schedule |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Trial of Hypofractionated Radiotherapy Post-Lumpectomy in Women With Node Negative Breast Cancer |
Resource links provided by NLM:
Further study details as provided by Ontario Clinical Oncology Group (OCOG):
Primary Outcome Measures:
- Local breast recurrence
Secondary Outcome Measures:
- Morbidity
- Cost effectiveness
| Enrollment: | 1234 |
| Study Start Date: | April 1993 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Hypofractionated whole breast radiation
Subjects treated with 4250 cGY in 16 fractions
|
Radiation: Hypofractionated whole breast radiation schedule |
|
Active Comparator: Conventional whole breast radiation
Subjects treated with 5000 cGY in 25 fractions
|
Radiation: Conventional whole breast radiation schedule |
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00156052
Locations
| Canada, Ontario | |
| Juravinski Cancer Centre | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Cancer Centre of Southeastern Ontario at Kingston General Hospital | |
| Kingston, Ontario, Canada, K7L 5P9 | |
| London Regional Cancer Centre | |
| London, Ontario, Canada, N6A 4L6 | |
| Ottawa Hospital-Integrated Cancer Program | |
| Ottawa, Ontario, Canada, K1H 1C4 | |
| Niagara Health System | |
| St. Catharines, Ontario, Canada, L2R 5K3 | |
| Regional Cancer Program of the Sudbury Regional Hospital | |
| Sudbury, Ontario, Canada, P3E 5J1 | |
| Regional Cancer Care - Thunder Bay HSC | |
| Thunder Bay, Ontario, Canada, P7B 6V4 | |
| Toronto Sunnybrook Regional Cancer Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| The Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Windsor Regional Cancer Centre | |
| Windsor, Ontario, Canada, N8W 2X3 | |
| Canada, Quebec | |
| Montreal General Hospital | |
| Montreal, Quebec, Canada, H3G 1A4 | |
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Investigators
| Study Chair: | Tim Whelan, MD | Juravinski Cancer Centre |
More Information
Publications:
| Responsible Party: | Ontario Clinical Oncology Group (OCOG) |
| ClinicalTrials.gov Identifier: | NCT00156052 History of Changes |
| Other Study ID Numbers: | OCOG-1993-hypo |
| Study First Received: | September 8, 2005 |
| Last Updated: | January 28, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Ontario Clinical Oncology Group (OCOG):
|
Breast Cancer Hypofractionated Radiotherapy Lumpectomy |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013