INNOVATION (EORTC 1203)
Research type
Research Study
Full title
INtegratioN of trastuzumab, with or without pertuzumab, into periOperatiVe chemotherApy of HER-2 posiTIve stOmach caNcer: The INNOVATION TRIAL.
IRAS ID
177557
Contact name
John Bridgewater
Contact email
Sponsor organisation
European Organization for the Research and Treatment of Cancer
Eudract number
2014-000722-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
8 years, 9 months, 1 days
Research summary
This is a randomised phase 3 study of 1 or 2 additional targeted therapies to standard chemotherapy in patients with operable stomach cancer. It is based on the efficacy of trastuzumab in inoperable disease and only patients who overexpress the HER-2 antigen, the target for trastuzumab, will be eligible (about 1 in 5 patients). Patients will be randomly allocated to receive chemotherapy and trastuzumab with or without pertuzumab, a novel anti-HER-2 agent. These agents will be given simultaneous to standard chemotherapy and will not prolong or significantly change the pathway of patients who are planned for oesophageal surgery. These agents have been chosen because of the efficacy of trastuzumab for neoadjuvant and adjuvant treatment in breast cancer, the efficacy of pertuzumab in HER-2 positive breast cancer for both neoadjuvant and palliative treatment and the similarities between the efficacy of trastuzumab in advanced gastric and breast cancer. The primary outcome measure will be the major pathological response rate (< 10% vital tumour cells) after neoadjuvant treatment by integrating either trastuzumab or both trastuzumab and pertuzumab. Secondary endpoints include the margin-free resection rate, pathological complete response, locoregional failure, distant failure, progression-free survival, recurrence-free survival, overall survival and toxicity. 180 patients will be recruited in a 1:2:2 ratio.
REC name
London - City & East Research Ethics Committee
REC reference
15/LO/0954
Date of REC Opinion
2 Aug 2015
REC opinion
Further Information Favourable Opinion