Radiation dose intensity study in breast cancer in young women: a randomised phase III trial of additional dose to the tumour bed
| ISRCTN | ISRCTN45066831 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45066831 |
| ClinicalTrials.gov number | NCT00212121 |
| Secondary identifying numbers | 1 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 14/02/2019
- 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
Prof H. Bartelink
Scientific
Scientific
Nederlands Kanker Instituut/ Antoni van Leeuwenhoek Ziekenhuis, Plesmanlaan 121
Amsterdam
1166 CX
Netherlands
| Phone | +31(0)20 512 2120/1731 |
|---|---|
| h.bartelink@nki.nl |
Study information
| Study design | Randomised active-controlled phase III trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Radiation dose intensity study in breast cancer in young women: a randomised phase III trial of additional dose to the tumour bed |
| Study acronym | Young Boost Trial |
| Study objectives | 10 Gy additional boost to the tumour bed will yield an increase in local control at 10 years from 88% to 93%, with still acceptable cosmesis. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Breast cancer |
| Intervention | All patients will be treated with breast conserving therapy, followed by 50 Gy to the whole breast. Patients will be randomised to receive a boost dose of 16 Gy or 26 Gy to the tumour bed. |
| Intervention type | Other |
| Primary outcome measure | Local control at 10 years. |
| Secondary outcome measures | 1. Cosmetic outcome 2. Additional objective is to test the genotypic and phenotypic profiles of breast tumours in young patients with invasive breast cancer, and its relation to: 2.1. Local recurrence after Breast Conserving Therapy (BCT) 2.2. Lymph node metastases 2.3. Distant metastases and survival 2.4. Radio sensitivity 2.5. Age 3. To determine whether improved genotypic and phenotypic profiles can be determined related to the endpoints mentioned in A |
| Overall study start date | 01/07/2004 |
| Completion date | 01/07/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 1160 |
| Key inclusion criteria | 1. Age 50 years or younger 2. Histological diagnosis of invasive mammary cancer including all subtypes of invasive adenocarcinoma 3. Tumour location and extension imaged prior to surgery using at least mammography and ultrasound 4. Unicentric tumours and multifocal tumours removed using a wide local excision; microscopic radical resection (focally involved margins allowed, defined as: any Ductal Carcinoma In Situ [DCIS] or invasive carcinoma in three or fewer low-power fields (using a x 4 objective and a x 10 ocular lens, which has a diameter of 5 mm per low-power microscopic fields) 5. Sentinel lymph node biopsy and/or axillary lymph node dissection has been performed 6. Breast cancer stage: pT1-2pN0-2a M0 7. No treatment is allowed prior to surgery (no neoadjuvant chemotherapy, no neoadjuvant hormonal therapy, no pre-operative radiotherapy) 8. In cases where no adjuvant chemotherapy is given, wide local excision has been performed less than 10 weeks before the start of radiotherapy 9. In cases where adjuvant chemotherapy is given immediately after surgery, wide local excision has been performed less than 6 months before the start of radiotherapy, and chemotherapy should be completed less than 6 weeks before the start of radiotherapy 10. In cases where hormonal treatment is planned, this is given after completion of the radiotherapy 11. No previous history or synchronous malignant tumour in the other breast, previous history of malignant disease, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin 12. Eastern Cooperative Oncology Group (ECOG) performance scale 2 or less |
| Key exclusion criteria | 1. Residual microcalcifications on mammogram 2. All histological types of malignancies other than invasive adenocarcinoma 3. In situ carcinoma of the breast, without invasive tumour 4. Concurrent pregnancy 5. Multicentric tumours, and multifocal tumours excised using multiple excisions 6. Invasive breast cancer in both breasts |
| Date of first enrolment | 01/07/2004 |
| Date of final enrolment | 01/07/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Nederlands Kanker Instituut/ Antoni van Leeuwenhoek Ziekenhuis, Plesmanlaan 121
Amsterdam
1166 CX
Netherlands
1166 CX
Netherlands
Sponsor information
Commission for Clinical Applied Research (Commissie voor Klinisch Toegepast Onderzoek [CKTO]) (The Netherlands)
Research organisation
Research organisation
Sophialaan 8
Amsterdam
1075 BR
Netherlands
Funders
Funder type
Research organisation
Commission for Clinical Applied Research (Commissie voor Klinisch Toegepast Onderzoek - CKTO) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | results presented at 3rd ESTRO Forum : | 01/04/2015 | 14/02/2019 | No | No |
| Abstract results | results presented at Clinical Science Symposium: | 01/04/2018 | 14/02/2019 | No | No |
Editorial Notes
14/02/2019: Publication references added.
