Accelerated Radiotherapy Outcomes in Women

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Ontario Clinical Oncology Group (OCOG).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Canadian Breast Cancer Research Alliance
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:
NCT00156130
First received: September 8, 2005
Last updated: January 28, 2013
Last verified: March 2009
  Purpose

This study is evaluating the long-term outcomes of women in a randomized trial that compared accelerated whole breast irradiation (42.5 Gy in 16 fractions over 22 days) to a longer conventional schedule of whole breast irradiation (50 Gy in 25 fractions over 35 days) following breast-conserving surgery. The outcomes evaluated will include cosmetic outcome and cardiac disease as a measure of late radiation morbidity and local breast recurrence as a measure of effectiveness.


Condition Intervention Phase
Breast Cancer
Radiation: Conventional radiotherapy schedule
Radiation: Accelarated radiotherapy schedule
Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Accelerated Radiotherapy Outcomes in Women (Long Term Outcomes of a Randomized Trial of Breast Irradiation Schedules After Lumpectomy in Women With Node-Negative Breast Cancer)(AROW)

Resource links provided by NLM:


Further study details as provided by Ontario Clinical Oncology Group (OCOG):

Estimated Enrollment: 1234
Study Start Date: October 2003
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Accelerated whole breast irradiation
Radiation: Accelarated radiotherapy schedule
42.5 Gy in 16 fractions over 22 days
2
Conventional whole breast irradiation
Radiation: Conventional radiotherapy schedule
50 Gy in 25 fractions over 35 days

Detailed Description:

This study is evaluating the long-term outcomes of women in a randomized trial that compared accelerated whole breast irradiation (42.5 Gy in 16 fractions over 22 days) to a longer conventional schedule of whole breast irradiation (50 Gy in 25 fractions over 35 days) following breast-conserving surgery. The results reported at 5 years demonstrated equivalence for these two different radiation schedules for the effect of local recurrence in the breast and cosmetic outcome. Emerging data has suggested that accelerated or shorter radiation schedules may potentially be associated with an increased risk of late morbidity of the skin, soft tissue and the heart at 10 years and beyond. The purpose of this study is to evaluate the long term outcomes of women randomized in the trial. The outcomes evaluated will include cosmetic outcome and cardiac disease as a measure of late radiation morbidity and local breast recurrence as a measure of effectiveness.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Extended long term follow-up of patients recruited into the "Randomized Trial of Hypofractionated Radiotherapy Post-Lumpectomy in Women with Node Negative Breast Cancer" study.

Criteria

Only patients recruited into the "Randomized Trial of Hypofractionated Radiotherapy Post-Lumpectomy in Women with Node Negative Breast Cancer" study are eligible to be enrolled into this study.

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 in situ 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156130

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
The Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
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)
Canadian Breast Cancer Research Alliance
Investigators
Study Chair: Timothy Whelan, MD Juravinski Cancer Centre
  More Information

No publications provided

Responsible Party: Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier: NCT00156130     History of Changes
Other Study ID Numbers: OCOG-2003-AROW, CBCRI-Grant-014366
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
Lumpectomy
Radiotherapy
Hypofractionated Radiotherapy
Long Term Outcomes

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 23, 2014