81
Participants
Start Date
June 30, 2016
Primary Completion Date
July 17, 2020
Study Completion Date
July 17, 2020
FLOT alone
"Pre-operative therapy:~* Docetaxel 50 mg/m², d1, d15, d29, d43~* Oxaliplatin 85 mg/m², d1, d15, d29, d43~* Leucovorin 200 mg/m², d1, d15, d29, d43 (can be replaced by sodium folinate according to local guidelines)~* 5-FU 2600 mg/m², d1, d15, d29, d43~Surgery is recommended to be scheduled 4 weeks after d43.~Post-operative therapy (start 6 to 8 weeks after surgery):~* Docetaxel 50 mg/m², d1, d15, d29, d43~* Oxaliplatin 85 mg/m², d1, d15, d29, d43~* Leucovorin 200 mg/m², d1, d15, d29, d43 (can be replaced by sodium folinate according to local guidelines)~* 5-FU 2600 mg/m², d1, d15, d29, d43"
FLOT + Herceptin/Pertuzumab
"Pre-operative therapy:~* Herceptin 8/6 mg/kg, d1, d22, d43~* Pertuzumab 840 mg, d1, d22, d43~* Docetaxel 50 mg/m², d1, d15, d29, d43~* Oxaliplatin 85 mg/m², d1, d15, d29, d43~* Leucovorin 200 mg/m², d1, d15, d29, d43 (can be replaced by sodium folinate according to local guidelines)~* 5-FU 2600 mg/m², d1, d15, d29, d43~Surgery is recommended to be scheduled 4 weeks after d43.~Post-operative therapy (start 6 to 8 weeks after surgery):~* Herceptin 8/6 mg/kg, d1, d22, d43~* Pertuzumab 840 mg, d1, d22, d43~* Docetaxel 50 mg/m², d1, d15, d29, d43~* Oxaliplatin 85 mg/m², d1, d15, d29, d43~* Leucovorin 200 mg/m², d1, d15, d29, d43 (can be replaced by sodium folinate according to local guidelines)~* 5-FU 2600 mg/m², d1, d15, d29, d43."
Institute for Clinical Cancer Research Krankenhaus Nordwest, Frankfurt
Trium Analysis Online GmbH
INDUSTRY
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
OTHER