FLOT vs. FLOT/Herceptin/Pertuzumab for Perioperative Therapy of HER-2 Expressing Gastric or GEJ Cancer

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

81

Participants

Timeline

Start Date

June 30, 2016

Primary Completion Date

July 17, 2020

Study Completion Date

July 17, 2020

Conditions
Stomach CancerGastroesophageal Junction Cancer
Interventions
DRUG

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"

BIOLOGICAL

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."

Trial Locations (1)

60488

Institute for Clinical Cancer Research Krankenhaus Nordwest, Frankfurt

All Listed Sponsors
collaborator

Trium Analysis Online GmbH

INDUSTRY

lead

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

OTHER

NCT02581462 - FLOT vs. FLOT/Herceptin/Pertuzumab for Perioperative Therapy of HER-2 Expressing Gastric or GEJ Cancer | Biotech Hunter | Biotech Hunter