Studieoverzicht - 2004-01 Young Boost

 
Number 2004-01 Young Boost
Nickname Young Boost
Status Follow up Date: 23-12-2011
Inclusion closed 23-12-2011
Other study number(s) CKTO 2003-13
Participating parties/groups France
Full title Radiation dose intensity study in breast cancer in young women: a randomized phase III trial of additional dose to the tumor bed
Phase and type Randomized Phase III
Age ≤ 50
Menopausal status Not applicable
Indication Locoregional
Subindication Not applicable
Target sample size 2400
Actual accrual 2422 (NL >1645) Date: 23-12-2011
Estimated study completion date 31-12-2011
CCMO approval Not applicable Date: Nr:
EudraCT nr. Not applicable
Trial Register ISRCTN45066831
METC approval Yes Date: 06-08-2004 METC: Nederlands Kanker Instituut Nr:
Amendments Yes Date: 16-03-2008
KWF-CKS approval Yes Date: Nr: CKTO 2003-13
News item
Website http://www.boogstudycenter.nl
Sponsor NKI-AVL
Principal Investigator(s) L.J. Boersma, Ph. Poortmans, J.W. Leer, H. Bartelink
Study manager
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
Local datamanagement
Funding Logo KWF NweHuisstijl 004-zonder slogan.jpgFunding by KWF
Extra

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
Main eligibility criteria:
  • Age ≤ 50 years,
  • pT1-2pN0-2a M0;
  • Breast conserving surgery
Documents (public):
Documents (protected):
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