Trial of Tomotherapy in Breast Cancer (TomoBreast)
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|ClinicalTrials.gov Identifier: NCT00459628|
Recruitment Status : Active, not recruiting
First Posted : April 12, 2007
Last Update Posted : May 16, 2017
|Condition or disease||Intervention/treatment|
|Breast Neoplasms||Radiation: Conventional radiotherapy Radiation: Tomotherapy|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||118 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Trial Comparing Conventional vs Short-course Reduced Volume Conformal Post-surgery Radiation Treatment in Women With Stage I or II Breast Cancer|
|Study Start Date :||May 2007|
|Primary Completion Date :||August 2011|
|Estimated Study Completion Date :||December 2017|
Active Comparator: Conventional radiotherapy
Conventional Long schedule Radiotherapy Arm
Radiation: Conventional radiotherapy
Radiation treatment delivered by conventional linear accelerator using matching fields
Other Name: Arm I, Long schedule
Short course schedule by tomotherapy
CT image guided intensity modulated radiation therapy delivered by the Tomotherapy HiArt system
Other Name: Arm II, Short schedule, Helical Tomotherapy
- Change from baseline in pulmonary function and heart function tests [ Time Frame: From end of treatment up to 3 years after treatment ]Assessment by pulmonary function tests and by heart echocardiography, compared with test values prior to treatment
- Local-regional recurrences. [ Time Frame: From end of treatment up to 15 years after treatment ]Local-regional recurrences are assessed at time intervals as per the institution's standard practice for the clinical surveillance of patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00459628
|Oncologisch Centrum, UZ Brussel|
|Jette, Brussels, Belgium, 1090|
|Study Director:||Mark De Ridder, MD, PhD||Radiotherapy Department, Universitair Ziekenhuis Brussel|
|Principal Investigator:||Vincent Vinh-Hung, MD, PhD||Radiotherapy-Oncology, Universitair Ziekenhuis Brussel|