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 |
| Protocol serial number | 2007/009 |
| Sponsor | University Hospital Brussels (Universitair Ziekenhuis Brussel [UZ Brussel]) (Belgium) |
| Funder | Foundation Against Cancer (Stichting tegen Kanker) (Belgium) |
- 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
Scientific
Oncologisch Centrum
UZ Brussel
Laarbeeklaan 101
Brussels
1090
Belgium
| Phone | +32 (0)2 477 6041 |
|---|---|
| conrvhgv@uzbrussel.be |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, controlled, single centre trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | TomoBreast |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 30/04/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 118 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/05/2007 |
| Date of final enrolment | 30/04/2010 |
Locations
Countries of recruitment
- Belgium
Study participating centre
Oncologisch Centrum
Brussels
1090
Belgium
1090
Belgium
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
