Accelerated Radiotherapy Outcomes in Women

May 6, 2016 updated by: Ontario Clinical Oncology Group (OCOG)

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1234

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Centre
      • Kingston, Ontario, Canada, K7L 5P9
        • Cancer Centre of Southeastern Ontario At Kingston General Hospital
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Centre
      • Ottawa, Ontario, Canada, K1H 1C4
        • Ottawa Hospital-Integrated Cancer Program
      • St. Catharines, Ontario, Canada, L2R 5K3
        • Niagara Health System
      • Sudbury, Ontario, Canada, P3E 5J1
        • Regional Cancer Program of the Sudbury Regional Hospital
      • Thunder Bay, Ontario, Canada, P7B 6V4
        • Regional Cancer Care - Thunder Bay HSC
      • Toronto, Ontario, Canada, M4N 3M5
        • Toronto Sunnybrook Regional Cancer Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • The Princess Margaret Hospital
      • Windsor, Ontario, Canada, N8W 2X3
        • Windsor Regional Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Montreal General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ontario Clinical Oncology Group (OCOG)

Collaborators

Canadian Breast Cancer Research Alliance

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (ESTIMATE)

September 12, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

May 9, 2016

Last Update Submitted That Met QC Criteria

May 6, 2016

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCOG-2003-AROW
  • CBCRI-Grant-014366

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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