Young Boost

BOOG 2004-01

General Information

BOOG number

BOOG 2004-01

Nickname

Young Boost

Status

Date: 23/12/2011

Inclusion closed

23/12/2011

Participating parties / group

France

Other study number

CKTO 2003-13

Full title

Radiation dose intensity study in breast cancer in young women: a randomized phase III trial of additional dose to the tumor bed

Indication

Subindication

Not applicable

Target sample size

2400

Actual accrual

2422 (NL >1645)
Date: 23/12/2011

Estimated study completion date

31/12/2011

Contact

Sponsor

NKI-AVL

Principal Investigator(s)

L.J. Boersma, Ph. Poortmans, J.W. Leer, H. Bartelink

Central datamanagement and randomization

NKI-AVL trialbureau
Plesmanlaan 121
1066 CX Amsterdam
Tel 020 5122668
Fax 020 5122679
E-mail trial@nki.nl

Monitoring

RT quality control via dummy runs

Funding

Funding by KWF

Other

Follow-up: Vanaf 10 jaar – 20 jaar na RT: – 1x per 2 jaar, en dat mag telefonisch -op 14 en 20 jaar “live”, en dan ook cosmetiek foto

Design

Randomization: Arm A: standard RT + high boost dose (26 Gy) Arm B: standard RT + low boost dose (16 Gy)

Objectives

A. The main objective is to compare the effect of a high boost dose (26 Gy) with a low boost dose (16 Gy) in breast conserving therapy, on the local recurrence rate. B. The secondary objective is to compare the effect of the high boost dose (26 Gy) with a low boost dose (16 Gy) in breast conserving therapy, on the cosmesis. Additional objectives: To test the genotypic and phenotypic profiles of breast tumors in young patients with invasive breast cancer, and its relation to: a. Local recurrence after BCT b. Lymph node metastases c. Distant metastases and survival d. Radiosensitivity e. Age To determine whether improved genotypic and phenotypic profiles can be determined related to the trial endpoints.

Endpoints

Primary endpoint:

  • Local control at 10 year

Secondary endpoint:

  • Cosmetic outcome

Eligibility Criteria

Age ≤ 50 years, pT1-2pN0-2a M0; Breast conserving surgery

Regulatory Information

CCMO approval

Yes

EC approval

Yes
Date: 06/08/2004

EC

Nederlands Kanker Instituut
Amendments:
Yes
Date Last Amendment: 16/03/2008

EudraCT number

Not applicable

Trial Register

ISRCTN45066831

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