Post-operative Radiation With IMRT in the Management of Stage IIB-III Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00508352
First received: July 25, 2007
Last updated: May 31, 2013
Last verified: May 2013
  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 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Post-operative Locoregional Irradiation Using Helical Tomotherapy IMRT in the Management of Stage IIb-III Breast Cancer: a Feasibility Study

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Acute radiation effects(less than 90 days post treatment) [ Time Frame: less than 90 days post treatment ] [ Designated as safety issue: Yes ]
  • Moderate-late pulmonary and cardiac radiation effects [ Time Frame: up to 1 year post radiation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of local recurrence [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Rate of regional recurrence [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: January 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Helical tomotherapy
Helical tomotherapy IMRT 50 Gy in 25 fractions, daily treatment
Procedure: Helical tomotherapy IMRT
Helical tomotherapy IMRT 50 Gy in 25 fractions, daily treatment

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
Accepts Healthy Volunteers:   No
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00508352

Locations
Canada, Ontario
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Jean-Michel Caudrelier, md OHRI
  More Information

No publications provided

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00508352     History of Changes
Other Study ID Numbers: 2006277-01H
Study First Received: July 25, 2007
Last Updated: May 31, 2013
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on August 26, 2014