NCT00156130

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,234

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2003

Longer than P75 for all trials

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

May 9, 2016

Status Verified

June 1, 2015

Enrollment Period

11.7 years

First QC Date

September 8, 2005

Last Update Submit

May 6, 2016

Conditions

Breast Cancer

Keywords

Breast CancerLumpectomyRadiotherapyHypofractionated RadiotherapyLong Term Outcomes

Study Arms (2)

1

Accelerated whole breast irradiation

Radiation: Accelarated radiotherapy schedule

2

Conventional whole breast irradiation

Radiation: Conventional radiotherapy schedule

Interventions

Conventional radiotherapy scheduleRADIATION

50 Gy in 25 fractions over 35 days

2
Accelarated radiotherapy scheduleRADIATION

42.5 Gy in 16 fractions over 22 days

1

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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 in situ of the cervix which have been effectively treated.
  • Geographic inaccessibility for follow-up.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Regional Cancer Program of the Sudbury Regional Hospital

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Kingston, Ontario, K7L 5P9, Canada

Location

London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Ottawa Hospital-Integrated Cancer Program

Ottawa, Ontario, K1H 1C4, Canada

Location

Niagara Health System

St. Catharines, Ontario, L2R 5K3, Canada

Location

Regional Cancer Care - Thunder Bay HSC

Thunder Bay, Ontario, P7B 6V4, Canada

Location

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

The Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Windsor Regional Cancer Centre

Windsor, Ontario, N8W 2X3, Canada

Location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Timothy Whelan, MD

    Juravinski Cancer Centre

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

October 1, 2003

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

May 9, 2016

Record last verified: 2015-06

Locations

CA(11)