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 |
 Funding by KWF |
|||
| Extra | 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 | |||
Randomization:
Arm A: standard RT + high boost dose (26 Gy)
Arm B: standard RT + low boost dose (16 Gy)
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.
Primary endpoint:
- Local control at 10 year
Secondary endpoint:
- Cosmetic outcome
- Age ≤ 50 years,
- pT1-2pN0-2a M0;
- Breast conserving surgery
Back