NCT00187343

Brief Summary

The purpose of this study is to determine whether the use of a 3D missing tissue compensation radiation technique during a standard adjuvant breast radiotherapy delivering a dose of 50Gy in 25 treatments could reduce significantly the occurence rate and the degree of acute skin reaction compared to a standard wedged irradiation technique.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
340

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2003

Geographic Reach
1 country

2 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

September 1, 2003

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

September 8, 2008

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

September 5, 2008

Conditions

Breast Neoplasms

Keywords

RadiotherapyIMRT

Outcome Measures

Primary Outcomes (1)

  • Maximum skin toxicity measured weekly during the tratment and bi-weekly up to one month after the end of the treatment and complete resolution of skin reaction using the NCI common toxicity criteria version 3.0 scale

Secondary Outcomes (7)

  • Breast localisation of maximum acute skin toxicity;

  • Time of onset of acute skin toxicity;

  • Pain assessment;

  • Duration of symptoms;

  • Factors associated with acute skin reactions;

  • +2 more secondary outcomes

Interventions

Breast IMRTDEVICE

Eligibility Criteria

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

You may qualify if:

  • A confirmed histological diagnosis of breast carcinoma or DCIS;
  • Treated by breast conserving surgery;
  • Adjuvant radiation to the breast only (less than 3 positive lymph nodes);
  • Having a ECOG performance status of 0 or 1.
  • Having signed an informed consent.

You may not qualify if:

  • Patients treated by mastectomy;
  • Bilateral breast cancer;
  • Having an unhealed surgical scar (skin not closed and/or infection);
  • Having had prior radiation to the same breast;
  • Having active connective tissue disorder;
  • Patient being pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

BC Cancer Agency-Vancouver Island Centre

Victoria, British Columbia, V8R6V5, Canada

Location

Sunnybrook and Women's College Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

Related Publications (1)

  • Mihai A, Rakovitch E, Sixel K, Woo T, Cardoso M, Bell C, Ruschin M, Pignol JP. Inverse vs. forward breast IMRT planning. Med Dosim. 2005 Fall;30(3):149-54. doi: 10.1016/j.meddos.2005.03.004.

    PMID: 16112466BACKGROUND

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jean-Philippe PIGNOL, MD, PhD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

September 1, 2003

Study Completion

June 1, 2005

Last Updated

September 8, 2008

Record last verified: 2005-09

Locations

CA(2)