Trial of Tomotherapy in Breast Cancer

Study Overview
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Brief Summary
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Tomotherapy is a new radiation therapy system that uses an integrated CT scanner during delivery of radiation treatment to improve the accuracy of the treatment. Furthermore the irradiation is delivered helicoidally allowing highly conformal shaping of dose distribution. However the magnitude of the clinical advantage of using the system in breast cancer is unknown. The purpose of the present study is to investigate whether or not the Tomotherapy can substantially reduce pulmonary and cardiac toxicities, as compared with conventional radiotherapy.

Detailed Description
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Prior to surgery: histological confirmation; medical imaging. Localizing markers are placed in case of breast conserving surgery. After surgery, patients are randomized to one of two treatment arms: Arm I: radiotherapy using tangential chest fields, and supraclavicular field in case of nodal involvement, according to our hospital's standard procedure (Voordeckers M et al, Radiother Oncol 2003;68:227 and 2004;70:225). Dose-fractionation: 50 Gy in 25 fractions over 5 weeks, 2 Gy/fraction. Additional boost 16 Gy in 8 fractions over 2 weeks if breast conserving surgery (verify marker/clip localization) and age <= 70 years. Arm II: radiotherapy using the Tomotherapy system. Target area (breast, thorax wall, nodal areas) delimited according to pre-operative imaging and pathological description. Dose-fractionation (adapted from Whelan T et al, JNCI 2002;94:1143): 42 Gy in 15 fractions over 3 weeks, 2.8 Gy/fraction. Simultaneous boost 0.6 Gy/fraction if breast conserving surgery. Physics quality control is integrated during treatment in both arms. Radiotherapy begins within 6 weeks after the last breast surgery. Concurrent or sequential adjuvant systemic treatments are allowed. In case of sequential adjuvant treatment with chemotherapy first, radiotherapy begins within 6 weeks after completion of the adjuvant chemotherapy. Quality of life, arm mobility and edema, pulmonary and heart function are assessed prior to radiotherapy, at 1-3 months after completion of radiotherapy, then yearly.

Official Title
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Randomized Trial Comparing Conventional vs Short-course Reduced Volume Conformal Post-surgery Radiation Treatment in Women With Stage I or II Breast Cancer

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Radiation: Conventional radiotherapy
* Radiation: Tomotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent Histologically proven breast carcinoma Stage I or II (T1-3N0 or T1-2N1 M0, AJCC/TNM 6th edition) Surgery with clear margins Pre-operative medical imaging (at least CT, MRI, and/or PET-scan) Exclusion Criteria: Prior breast or thoracic radiotherapy Pregnancy or lactation Fertile patients without effective contraception Psychiatric or addictive disorders

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional radiotherapy<br>Conventional Long schedule Radiotherapy Arm | Radiation: Conventional radiotherapy<br>* Radiation treatment delivered by conventional linear accelerator using matching fields<br>* Other names: Arm I, Long schedule;|
| Experimental: Tomotherapy<br>Short course schedule by tomotherapy | Radiation: Tomotherapy<br>* CT image guided intensity modulated radiation therapy delivered by the Tomotherapy HiArt system<br>* Other names: Arm II, Short schedule, Helical Tomotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in pulmonary function and heart function tests | Assessment by pulmonary function tests and by heart echocardiography, compared with test values prior to treatment | From end of treatment up to 3 years after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local-regional recurrences. | Local-regional recurrences are assessed at time intervals as per the institution's standard practice for the clinical surveillance of patients. | From end of treatment up to 15 years after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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early breast cancer, post-operative radiation treatment