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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00156052
First Posted: September 12, 2005
Last Update Posted: June 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)
September 8, 2005
September 12, 2005
June 8, 2015
April 1993
June 2015   (Final data collection date for primary outcome measure)
Local breast recurrence [ Time Frame: Indefinitely ]
Local breast recurrence
Complete list of historical versions of study NCT00156052 on ClinicalTrials.gov Archive Site
  • Morbidity [ Time Frame: Indefinitely ]
  • Cost effectiveness [ Time Frame: Indefinitely ]
  • Morbidity
  • Cost effectiveness
Not Provided
Not Provided
 
Hypofractionated Radiotherapy Post-Lumpectomy in Women With Node Negative Breast Cancer
A Randomized Trial of Hypofractionated Radiotherapy Post-Lumpectomy in Women With Node Negative Breast Cancer

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
  • Radiation: Conventional whole breast radiation schedule
  • Radiation: Hypofractionated whole breast radiation schedule
  • Experimental: Hypofractionated whole breast radiation
    Subjects treated with 4250 cGY in 16 fractions
    Intervention: Radiation: Hypofractionated whole breast radiation schedule
  • Active Comparator: Conventional whole breast radiation
    Subjects treated with 5000 cGY in 25 fractions
    Intervention: Radiation: Conventional whole breast radiation schedule

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1234
June 2015
June 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00156052
OCOG-1993-hypo
No
Not Provided
Not Provided
Ontario Clinical Oncology Group (OCOG)
Ontario Clinical Oncology Group (OCOG)
Not Provided
Study Chair: Tim Whelan, MD Juravinski Cancer Centre
Ontario Clinical Oncology Group (OCOG)
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP