A Clinical Trial to Reduce Skin Burn Induced by Breast Radiotherapy Using Intensity Modulated Radiation Therapy (IMRT)

This study has been completed.
Sponsor:
Collaborator:
British Columbia Cancer Agency
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00187343
First received: September 12, 2005
Last updated: September 5, 2008
Last verified: September 2005
  Purpose

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.


Condition Intervention Phase
Breast Neoplasms
Device: Breast IMRT
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase III Study of Adjuvant Radiation Therapy in Early Breast Cancer Comparing the Use of Breast Intensity Modulated Radiation Therapy (IMRT) to Conventional Wedge Technique

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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;
  • HRQOL;
  • Drug prescription for skin care.

Estimated Enrollment: 340
Study Start Date: September 2003
Estimated Study Completion Date: June 2005
Detailed Description:
  1. Description of the Problem:

    The majority of breast cancer patients are treated with breast-conserving surgery followed by radiotherapy, giving loco-regional control rates similar to mastectomy. Currently, the "standard" breast radiotherapy technique includes treatment of the entire breast with a tangential opposed pair of photon beams. The standard technique leads to significant acute skin toxicity, ranging from breast erythema to moist desquamation, in approximately 40% of patients. This toxicity may lead to interruptions in treatment delivery; may increase the risk of developing late skin toxicity including telangiectasia, skin fibrosis and chronic breast pain; and may also be associated with a significant decrease in health-related quality of life (HRQOL). Published data from dosimetric studies suggest that dose variations in excess of 10% within the breast may be the most important predictor of acute radiation-induced skin toxicity (RR = 9.7), and that dose toxicity occurs more frequently in the inframamary fold. A study performed at TSRCC shows that intensity modulated radiotherapy (IMRT) allows for significant improvements in dose homogeneity within the breast compared to standard breast radiotherapy techniques. Furthermore, the hot spot over 10% seen in the inframamary fold for patient with large breast volume is removed.

  2. Objectives:

    • To determine if the occurence of acute skin toxicity in women receiving adjuvant breast radiation with IMRT is less frequent compared to women treated with conventional technique.
    • To determine if the HRQOL scores, and specifically breast module subscale scores, in women receiving adjuvant breast radiation with IMRT is better than HRQOL scores in women receiving conventional technique.
    • To perform a comparison of costs in the delivery of breast radiotherapy using IMRT to conventional technique.
    • To determine if an increased acute skin toxicity translates into an increased late skin toxicity.
  3. Hypothesis:

We hypothesize that women receiving adjuvant breast radiation with IMRT will have significantly less acute skin toxicity and improved HRQOL compared to women treated with conventional techniques. We also hypothesize that there would not be increased cost related to IMRT compared to conventional technique.

Research plan: A Phase III randomised controled trial is planned, with blocked stratification on breast size and boost delivery. Eligible women include those who have been referred to TSRCC following breast-conserving surgery. They will be randomized to receive either a conventional technique treatment, either breast IMRT. Acute skin toxicity will be assessed weekly during radiotherapy and up to one month following completion of radiotherapy using the previously validated RTOG acute skin toxicity scale. The occurence, duration and intensity of acute skin toxicity will be compared. HRQOL will be assessed during and after irradiation, using validated EORTC instruments (EORTC QLQ-C30 and QLQ-BR23). 340 patients will be accrued in order to detect a 15% reduction in the ocurence of acute skin toxicity with IMRT using an a=0.05, b=0.80.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187343

Locations
Canada, British Columbia
BC Cancer Agency-Vancouver Island Centre
Victoria, British Columbia, Canada, V8R6V5
Canada, Ontario
Sunnybrook and Women's College Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
British Columbia Cancer Agency
Investigators
Principal Investigator: Jean-Philippe PIGNOL, MD, PhD Sunnybrook Health Sciences Centre
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00187343     History of Changes
Other Study ID Numbers: BreastIMRT
Study First Received: September 12, 2005
Last Updated: September 5, 2008
Health Authority: Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:
Radiotherapy
IMRT

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014