Randomised trial comparing conventional versus short-course reduced volume conformal post-surgery radiation treatment in women with stage I or II Breast cancer

ISRCTN ISRCTN21164902
DOI https://doi.org/10.1186/ISRCTN21164902
Secondary identifying numbers 2007/009
Submission date
10/04/2007
Registration date
13/04/2007
Last edited
07/05/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Vincent Vinh-Hung
Scientific

Oncologisch Centrum
UZ Brussel
Laarbeeklaan 101
Brussels
1090
Belgium

Phone +32 (0)2 477 6041
Email conrvhgv@uzbrussel.be

Study information

Study designRandomised, controlled, single centre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymTomoBreast
Study objectivesTo 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(s)Approved by the Medical Ethics Committee of the UZ Brussel on the 29th March 2007 (ref: 2007/009; B.U.N. ref: B14320071552).
Health condition(s) or problem(s) studiedBreast cancer
InterventionPatients 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 typeOther
Primary outcome measurePulmonary 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 measuresLocal-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 study start date01/05/2007
Completion date30/04/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants118
Key inclusion criteria1. 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)
Key exclusion criteria1. 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
Date of first enrolment01/05/2007
Date of final enrolment30/04/2010

Locations

Countries of recruitment

  • Belgium

Study participating centre

Oncologisch Centrum
Brussels
1090
Belgium

Sponsor information

University Hospital Brussels (Universitair Ziekenhuis Brussel [UZ Brussel]) (Belgium)
Hospital/treatment centre

c/o Dr Vincent Vinh-Hung
Radiotherapy-Oncology Department
Laarbeeklaan 101
Brussels
1090
Belgium

Phone +32 (0)2 477 6041
Email conrvhgv@uzbrussel.be
Website http://www.uzbrussel.be
ROR logo "ROR" https://ror.org/038f7y939

Funders

Funder type

Charity

Foundation Against Cancer (Stichting tegen Kanker) (Belgium)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 16/05/2012 Yes No