NCT00138814

Brief Summary

This is a two arm randomized study for patients who are undergoing radiotherapy following breast conservation surgery for breast cancer. Local recurrence of breast cancer will be compared for patients receiving boost or no boost radiotherapy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
680

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 1997

Longer than P75 for phase_3

Geographic Reach
1 country

3 active sites

Status
unknown

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

January 1, 1997

Completed
8.7 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2005

Completed
10.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 15, 2005

Status Verified

September 1, 2005

First QC Date

August 29, 2005

Last Update Submit

December 14, 2005

Conditions

Breast Neoplasms

Keywords

Neoplasm recurrence, localRadiotherapy dosageCosmesisMastectomy, segmental

Outcome Measures

Primary Outcomes (1)

  • Local failure of breast cancer at 72 month median follow-up and 10 year median follow-up for final analysis

Secondary Outcomes (3)

  • Local control translating to survival over 10 year median follow-up

  • Quality of life at yearly intervals with reference to baseline

  • Breast cosmesis - patient assessment and photos

Interventions

Radiotherapy (boost versus no boost)PROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven carcinoma of the breast, T1-2 (0-5cm) N0-1, M0.
  • Pure ductal carcinoma in situ accepted if completely excised.
  • Any receptor status.
  • Extensive intraductal cancer (EIC) accepted if completely excised.

You may not qualify if:

  • Unable to consent
  • Vascular/collagen disorder
  • Prior malignancy except minor skin squamous cell or basal cell carcinoma or carcinoma in-situ of the cervix .
  • Gross multifocal disease
  • Involvement of margins.
  • Bilateral breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Liverpool Hospital

Sydney, New South Wales, 2170, Australia

RECRUITING

Cancer Care Centre, St George Hospital

Sydney, New South Wales, 2217, Australia

RECRUITING

Wollongong Hospital

Wollongong, New South Wales, 2500, Australia

RECRUITING

Related Publications (4)

  • Browne LH, Graham PH. Good intentions and ICH-GCP: Trial conduct training needs to go beyond the ICH-GCP document and include the intention-to-treat principle. Clin Trials. 2014 Dec;11(6):629-34. doi: 10.1177/1740774514542620. Epub 2014 Jul 14.

    PMID: 25023199DERIVED

  • Hau E, Browne L, Capp A, Delaney GP, Fox C, Kearsley JH, Millar E, Nasser EH, Papadatos G, Graham PH. The impact of breast cosmetic and functional outcomes on quality of life: long-term results from the St. George and Wollongong randomized breast boost trial. Breast Cancer Res Treat. 2013 May;139(1):115-23. doi: 10.1007/s10549-013-2508-z. Epub 2013 Apr 12.

    PMID: 23580069DERIVED

  • Hau E, Browne LH, Khanna S, Cail S, Cert G, Chin Y, Clark C, Inder S, Szwajcer A, Graham PH. Radiotherapy breast boost with reduced whole-breast dose is associated with improved cosmesis: the results of a comprehensive assessment from the St. George and Wollongong randomized breast boost trial. Int J Radiat Oncol Biol Phys. 2012 Feb 1;82(2):682-9. doi: 10.1016/j.ijrobp.2010.11.025. Epub 2011 Jan 20.

    PMID: 21255943DERIVED

  • Millar EK, Graham PH, O'Toole SA, McNeil CM, Browne L, Morey AL, Eggleton S, Beretov J, Theocharous C, Capp A, Nasser E, Kearsley JH, Delaney G, Papadatos G, Fox C, Sutherland RL. Prediction of local recurrence, distant metastases, and death after breast-conserving therapy in early-stage invasive breast cancer using a five-biomarker panel. J Clin Oncol. 2009 Oct 1;27(28):4701-8. doi: 10.1200/JCO.2008.21.7075. Epub 2009 Aug 31.

    PMID: 19720911DERIVED

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm Recurrence, Local

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Associate Prof. Peter H Graham, MBBS FRANZCR

    Cancer Care Centre, St George Hospital, Sydney, Australia

    PRINCIPAL INVESTIGATOR

  • Dr Geoff Delaney, MBBS FRANZCR

    Liverpool Hospital, Sydney, Australia

    PRINCIPAL INVESTIGATOR

  • Dr Chris Fox, MBBS FRANZCR

    Wollongong Hospital, Wollongong, Australia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Associate Prof. Peter H Graham, MBBS FRANZCR

CONTACT

+61 29350 3912GrahamP@sesahs.nsw.gov.au

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 30, 2005

Study Start

January 1, 1997

Study Completion

December 1, 2015

Last Updated

December 15, 2005

Record last verified: 2005-09

Locations

AU(3)