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

NCT00508352 | Completed Results

• 1 other identifier: 2006277-01H
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

breast; cancer; locoregional; IMRT; tomotherapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Rate of Local Recurrence

  5 years

• Rate of Regional Recurrence

  5 years

Study Arms (1)

Helical tomotherapy

EXPERIMENTAL

Helical tomotherapy IMRT 50 Gy in 25 fractions, daily treatment

Procedure: Helical tomotherapy IMRT

Interventions

Helical tomotherapy IMRT PROCEDURE

Helical tomotherapy IMRT 50 Gy in 25 fractions, daily treatment

Helical tomotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Surgery with either mastectomy or breast conserving surgery
• 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)
• All patients will have been treated previously with chemotherapy prior to radiation therapy
• ECOG performance status of 2 or less

You may not qualify if:

• Prior chest wall/breast or nodal radiation for other malignancies (i.e. Hodgkin disease)
• HER2+ positive patients
• Patients with diagnosis of metastatic disease
• Prior or active malignancy except non-melanoma skin carcinoma within 5 years of the diagnosis of breast cancer

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital Regional Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

Related Publications (1)

• 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.

  PMID: 25052720 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Jean-Michel Caudrelier
• Organization: Ottawa Hospital Research Institute

jcaudrelier@toh.ca

613-737-8899

Study Officials

• Jean-Michel Caudrelier, md

  OHRI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2007
• First Posted: July 27, 2007
• Study Start: January 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: June 13, 2025
• Results First Posted: June 13, 2025

Record last verified: 2025-05

Locations

CA (1)