NEO trial

• Research type

  Research Study

• Full title

  A Phase II, Open-Label, Randomized, Multi-Centre Study, of Neoadjuvant Olaparib in Patients with Platinum Sensitive Recurrent High Grade Serous Ovarian/Primary Peritoneal or Fallopian tube Cancer.

• IRAS ID

  235449

• Contact name

  Amit Oza

• Contact email

  Amit.oza@uhn.ca

• Sponsor organisation

  University Health Network, Toronto

• Eudract number

  2016-002573-35

• Clinicaltrials.gov Identifier

  NCT02489006

• Duration of Study in the UK

  4 years, 5 months, 1 days

• Research summary

  A Phase II study investigating olaparib followed by surgery and postoperative chemotherapy versus olaparib in women with platinum-sensitive ovarian cancer. Study duration is approximately 3.5 years, including 1 year of recruitment, minimum 6 months of treatment and a 2 years of follow-up. A total of 71 patients are expected to enroll. Patients will be given olaparib 300mg twice daily for 6 weeks pre-operatively followed by secondary ovarian tumor debulking surgery. Patients will then be randomized to receive either chemotherapy or single agent oral olaparib. All patients will receive maintenance olaparib until progression.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  19/LO/0817

• Date of REC Opinion

  30 Aug 2019

• REC opinion

  Further Information Favourable Opinion