Condition category
Cancer
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
17/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.trialsonline.net

Contact information

Type

Scientific

Primary contact

Prof H. Bartelink

ORCID ID

Contact details

Nederlands Kanker Instituut/ Antoni van Leeuwenhoek Ziekenhuis
Plesmanlaan 121
Amsterdam
1166 CX
Netherlands
+31(0)20 512 2120/1731
h.bartelink@nki.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00212121

Protocol/serial number

1

Study information

Scientific title

Acronym

Young Boost Trial

Study hypothesis

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

Ethics approval received from the local medical ethics committee

Study design

Randomised, active controlled, phase III trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Phase III

Drug names

Primary outcome measures

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 trial start date

01/07/2004

Overall trial end date

01/07/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

1160

Participant 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

Recruitment start date

01/07/2004

Recruitment end date

01/07/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Nederlands Kanker Instituut/ Antoni van Leeuwenhoek Ziekenhuis, Plesmanlaan 121
Amsterdam
1166 CX
Netherlands

Sponsor information

Organisation

Commission for Clinical Applied Research (Commissie voor Klinisch Toegepast Onderzoek [CKTO]) (The Netherlands)

Sponsor details

Sophialaan 8
Amsterdam
1075 BR
Netherlands

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Commission for Clinical Applied Research (Commissie voor Klinisch Toegepast Onderzoek - CKTO) (The Netherlands)

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes