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NCT Number: NCT00508352

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Ottawa Hospital Regional Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Helical tomotherapy IMRT

Procedure

Helical tomotherapy IMRT 50 Gy in 25 fractions, daily treatment

Primary outcomes

  1. Acute Radiation Effects (Less Than 90 Days Post Treatment)

    Time frame: less than 90 days post treatment

    Grade 3 or higher radiation effects(less than 90 days post treatment)

  2. Moderate-late Pulmonary and Cardiac Radiation Effects

    Time frame: up to 1 year post radiation

    Grade 3 or higher moderate-late pulmonary and cardiac radiation effects up to 1 year post radiation

Secondary outcomes

  1. Rate of Local Recurrence

    Time frame: 5 years

    Evaluate rate of local recurrence at 5 years

  2. Rate of Regional Recurrence

    Time frame: 5 years

    Evaluate rate of regional recurrence at 5 years

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jul 27, 2007
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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