Trial of Tomotherapy in Breast Cancer (TomoBreast)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
|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|
- 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.
|Study Start Date:||May 2007|
|Estimated Study Completion Date:||December 2017|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|