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

Post-operative Locoregional Irradiation Using Helical Tomotherapy IMRT in the Management of Stage IIb-III Breast Cancer: a Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Helical tomotherapy IMRT

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital Regional Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Radiation Effects (Less Than 90 Days Post Treatment)	Grade 3 or higher radiation effects(less than 90 days post treatment)	less than 90 days post treatment
Moderate-late Pulmonary and Cardiac Radiation Effects	Grade 3 or higher moderate-late pulmonary and cardiac radiation effects up to 1 year post radiation	up to 1 year post radiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Local Recurrence	Evaluate rate of local recurrence at 5 years	5 years
Rate of Regional Recurrence	Evaluate rate of regional recurrence at 5 years	5 years

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Investigators: Principal Investigator: Jean-Michel Caudrelier, md, OHRI

Publications and helpful links

General Publications

• Caudrelier JM, Meng J, Esche B, Grimard L, Ruddy T, Amjadi K. IMRT sparing of normal tissues in locoregional treatment of breast cancer. Radiat Oncol. 2014 Jul 22;9:161. doi: 10.1186/1748-717X-9-161.

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: July 25, 2007
• First Submitted That Met QC Criteria: July 26, 2007
• First Posted (Estimated): July 27, 2007

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: May 28, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: cancer; breast; IMRT; locoregional; tomotherapy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2006277-01H