28
Participants
Start Date
April 30, 2012
Primary Completion Date
May 31, 2019
Study Completion Date
March 13, 2020
Olaparib
"Olaparib will be given orally BID for 36 days, administrated with a 12 hour interval. Olaparib will start 2 days before RT and will continue for 2 days after the last RT fraction. Olaparib is also given during the non-radiotherapy days but no maintenance treatment is given after radiotherapy is finished.~The first cohort will receive Olaparib with a dose of 25mg BID combined with Cisplatin and RT. Thereafter in both with and without cisplatin arms dose escalation will follow to 50mg, 100mg, 200mg, 300mg and 400mg BID."
Cisplatin
6 mg/m2 (5 days/week), 1-1.5 hr before the irradiation (week 1 to 5), given as a 5-minutes intravenous infusion.
Radiation
A total dose of 66 Gy will be given in 24 fractions from week 1 to 5, excluding the weekends.
Netherlands Cancer Institute - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL), Amsterdam
Collaborators (1)
AstraZeneca
INDUSTRY
The Netherlands Cancer Institute
OTHER