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Post-Operative Radiation With IMRT in the Management of Stage IIB-III Breast Cancer
This study is currently recruiting participants.
Verified by Ottawa Health Research Institute, July 2007
Sponsored by: Ottawa Health Research Institute
Information provided by: Ottawa Health Research Institute
ClinicalTrials.gov Identifier: NCT00508352
  Purpose

Research has shown that treatment with conventional radiation techniques and chemotherapy following mastectomy or breast conserving surgery has resulted in better rates of locoregional control and overall survival in stage IIB-III breast cancer. The current feasibility trial using the most recent advance in radiation therapy, namely helical tomotherapy intensity modulated radiation therapy (HT-IMRT), hopes to improve on the results of conventional radiation by decreasing the amount of radiation-induced toxicity in patients with stage IIb-III breast cancer.


Condition Intervention Phase
Breast Cancer
Procedure: Helical tomotherapy IMRT
Phase I
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Post-Operative Locoregional Irradiation Using Helical Tomotherapy IMRT in the Management of Stage IIb-III Breast Cancer: a Feasibility Study

Further study details as provided by Ottawa Health Research Institute:

Primary Outcome Measures:
  • Acute radiation effects(less than 90 days post treatment)
  • Moderate-late pulmonary and cardiac radiation effects
  • Late radiation effects(greater than 90 days post treatment)

Secondary Outcome Measures:
  • Rate of local recurrence
  • Rate of regional recurrence
  • Rate of overall survival
  • Quality of Life

Estimated Enrollment: 30
Study Start Date: January 2007
Estimated Study Completion Date: January 2010
Detailed Description:

The role of locoregional radiation therapy in the management of stage IIB and III breast cancer has evolved and continues to evolve. The exact role of locoregional radiation, including axillary, supraclavicular and internal mammary nodes is, however, not clear. Radiation-induced toxicity remains a limiting factor to expanding the indications for radiation therapy to axillary and internal mammary nodes in the treatment of stage IIB and III breast cancer. Excellent target coverage and normal tissue sparing of IMRT has been previously demonstrated dosimetrically and clinically. In this feasibility study, patients will receive 50 Gy of radiation therapy in 25 fractions to the chest wall and supraclavicular, axillary and IM nodal areas using HT-IMRT following breast conserving surgery or mastectomy and chemotherapy. Patients will also be eligible for a radiation boost to 12 Gy by HT-IMRT or HDR brachytherapy. It is expected that treatment with HT-IMRT will result in appreciably fewer side-effects following locoregional irradiation due to a reduction in normal tissue irradiation, as compared to conventional radiation therapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Criteria

Inclusion Criteria:

  1. Surgery with either mastectomy or breast conserving surgery
  2. Presence and association of any of the following high risk pathological features present at time of surgery: stage pT3-4 and pN0 and central/medial location of tumour or any pT and pN2 (stage IIB-stage III)
  3. All patients will have been treated previously with chemotherapy prior to radiation therapy
  4. ECOG performance status of 2 or less

Exclusion Criteria:

  1. Prior chest wall/breast or nodal radiation for other malignancies (i.e. Hodgkin disease)
  2. HER2+ positive patients
  3. Patients with diagnosis of metastatic disease
  4. Prior or active malignancy except non-melanoma skin carcinoma within 5 years of the diagnosis of breast cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00508352

Locations
Canada, Ontario
The Ottawa Hospital Regional Cancer Centre Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Pamela Cogan     613-737-7700 ext 79767     pcogan@ohri.ca    
Contact: Scott Grimes     613-737-7700 ext 70523     sgrimes@ohri.ca    
Principal Investigator: Jean-Michel Caudrelier, MD            
Sponsors and Collaborators
Ottawa Health Research Institute
Investigators
Principal Investigator: Jean-Michel Caudrelier, md OHRI
  More Information

Study ID Numbers: 2006277-01H, OTT 06-03
Study First Received: July 25, 2007
Last Updated: July 26, 2007
ClinicalTrials.gov Identifier: NCT00508352  
Health Authority: Canada: Health Canada

Keywords provided by Ottawa Health Research Institute:
breast
cancer
locoregional
IMRT
tomotherapy

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009