Contact information
Type
Scientific
Primary contact
Dr Vincent Vinh-Hung
ORCID ID
Contact details
Oncologisch Centrum
UZ Brussel
Laarbeeklaan 101
Brussels
1090
Belgium
+32 (0)2 477 6041
conrvhgv@uzbrussel.be
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2007/009
Study information
Scientific title
Acronym
TomoBreast
Study hypothesis
To test that short course adjuvant radiotherapy with the Tomotherapy system will substantially reduce the incidence of pulmonary and cardiac toxicities, as compared with conventional radiotherapy.
Ethics approval
Approved by the Medical Ethics Committee of the UZ Brussel on the 29th March 2007 (ref: 2007/009; B.U.N. ref: B14320071552).
Study design
Randomised, controlled, single centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Breast cancer
Intervention
Patients eligible for adjuvant post-surgery radiotherapy are randomised between treatment by conventional radiotherapy (control arm) and treatment with Tomotherapy (experimental arm).
Arm I (control, conventional radiotherapy):
Radiotherapy using tangential chest fields, and supraclavicular field in case of nodal involvement, according to our hospital's standard procedure.
Dose-fractionation: 50 Gy in 25 fractions over five weeks, 2 Gy/fraction. Additional boost 16 Gy in 8 fractions over two weeks if breast conserving surgery and aged less than or equal to 70 years.
Arm II (experimental) radiotherapy using the Tomotherapy system:
Target area (breast, thorax wall, nodal areas) delimited according to pre-operative imaging and pathological description.
Dose-fractionation: 42 Gy in 15 fractions over 3 weeks, 2.8 Gy/fraction. Simultaneous boost 0.6 Gy/fraction if breast conserving surgery.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Pulmonary and cardiac toxicities: this will be assessed by respiratory and heart function tests at one to three months after completion of radiotherapy then yearly for three years.
Secondary outcome measures
Local-regional recurrences: this will be assessed at one month after completion of radiotherapy then every three months for three years, then every six months for three years, then yearly thereafter.
Overall trial start date
01/05/2007
Overall trial end date
30/04/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Informed consent
2. Women
3. Age 18 years or older
4. Histologically proven invasive breast carcinoma, stage I or II (T1-3N0 or T1-2N1M0, TNM 6th edition)
5. Surgery with clear margins
6. Pre-operative medical imaging (at least Computed Tomography [CT], Magnetic Resonance Imaging [MRI], and/or Positron Emission Tomography [PET]-scan)
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
118
Participant exclusion criteria
1. Patients who do not match inclusion criteria
2. Prior breast or thoracic radiotherapy
3. Pregnancy or lactation
4. Fertile patients without effective contraception
5. Psychiatric or addictive disorders
Recruitment start date
01/05/2007
Recruitment end date
30/04/2010
Locations
Countries of recruitment
Belgium
Trial participating centre
Oncologisch Centrum
Brussels
1090
Belgium
Sponsor information
Organisation
University Hospital Brussels (Universitair Ziekenhuis Brussel [UZ Brussel]) (Belgium)
Sponsor details
c/o Dr Vincent Vinh-Hung
Radiotherapy-Oncology Department
Laarbeeklaan 101
Brussels
1090
Belgium
+32 (0)2 477 6041
conrvhgv@uzbrussel.be
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Foundation Against Cancer (Stichting tegen Kanker) (Belgium)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22591589
Publication citations
-
Results
Adriaenssens N, De Ridder M, Lievens P, Van Parijs H, Vanhoeij M, Miedema G, Voordeckers M, Versmessen H, Storme G, Lamote J, Pauwels S, Vinh-Hung V, Scapula alata in early breast cancer patients enrolled in a randomized clinical trial of post-surgery short-course image-guided radiotherapy., World J Surg Oncol, 2012, 10, 86, doi: 10.1186/1477-7819-10-86.