Clinical trial NCT00156130: Accelerated Radiotherapy Outcomes in Women
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast Cancer
Lumpectomy
Radiotherapy
Hypofractionated Radiotherapy
Long Term Outcomes
Lead sponsor: Ontario Clinical Oncology Group (OCOG)
Sponsor class: OTHER
Collaborators: name: Canadian Breast Cancer Research Alliance
First posted: 2005-09-12
Enrollment: 1234
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: Kingston
country: Canada
facility: Cancer Centre of Southeastern Ontario at Kingston General Hospital
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital-Integrated Cancer Program
state: Ontario
city: St. Catharines
country: Canada
facility: Niagara Health System
state: Ontario
city: Sudbury
country: Canada
facility: Regional Cancer Program of the Sudbury Regional Hospital
state: Ontario
city: Thunder Bay
country: Canada
facility: Regional Cancer Care - Thunder Bay HSC
state: Ontario
city: Toronto
country: Canada
facility: Toronto Sunnybrook Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: The Princess Margaret Hospital
state: Ontario
city: Windsor
country: Canada
facility: Windsor Regional Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
affiliation: Juravinski Cancer Centre
name: Timothy Whelan, MD
role: STUDY_CHAIR
References: