Trial of Tomotherapy in Breast Cancer (TomoBreast)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Neoplasms |
Radiation: Conventional radiotherapy Radiation: Tomotherapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label 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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]Local-regional recurrences are assessed at time intervals as per the institution's standard practice for the clinical surveillance of patients.
| Estimated Enrollment: | 118 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Conventional RT
Conventional Long schedule Radiotherapy Arm
|
Radiation: Conventional radiotherapy
Radiation treatment delivered by conventional linear accelerator using matching fields
Other Name: Arm I, Long schedule
|
|
Experimental: Tomotherapy
Short course schedule by tomotherapy
|
Radiation: Tomotherapy
CT image guided intensity modulated radiation therapy delivered by the Tomotherapy HiArt system
Other Name: Arm II, Short schedule, Helical Tomotherapy
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Belgium | |
| 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 |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Vincent Vinh-Hung, MD, PhD, Clinical Professor, Vrije Universiteit Brussel |
| ClinicalTrials.gov Identifier: | NCT00459628 History of Changes |
| Other Study ID Numbers: | 2007/009, 2007-002025-69, SCIE2006-30, ANI47 |
| Study First Received: | April 11, 2007 |
| Last Updated: | September 12, 2011 |
| Health Authority: | Belgium: Institutional Review Board |
Keywords provided by Vrije Universiteit Brussel:
|
early breast cancer post-operative radiation treatment |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013