Table 3. Principal ongoing trials in neoadjuvant HER2-positive gastric or gastroesophageal cancer.
TRIAL | REGIMEN | PHASE | PRIMARY ENDPOINT | |
---|---|---|---|---|
Experimental Arm | Control Arm | |||
HERFLOT NCT01472029 | 5-FU + Leucovorin + Oxaliplatin + Docetaxel + Trastuzumab 6 mg/kg iv loading dose, followed by 4 mg/kg iv every 2 weeks | 5-FU + Leucovorin + Oxaliplatin + Docetaxel | II | pCR |
PETRARCA NCT02581462 | 5-FU + Leucovorin + Oxaliplatin + Docetaxel + Trastuzumab 8 mg/kg iv loading dose, followed by 6 mg/kg iv every 3 weeks +Pertuzumab 840 mg every 3 weeks | 5-FU + Leucovorin + Oxaliplatin + Docetaxel | II/III | pCR/PFS |
INNOVATION NCT02205047 | 5-FU/Capecitabine + Cisplatin + Trastuzumab/Pertuzumab | 5-FU/Capecitabine + Cisplatin | II | pCR |
TOXAG NCT01748773 | RT at Total dose of 45 Gy divided into 25 doses +Capecitabine + Oxaliplatin + Trastuzumab 8 mg/kg iv loading dose, followed by 6 mg/kg iv every 3 weeks | // | II | Safety |
RTOG 1010 NCT01196390 | RT + Paclitaxel + Carboplatin + Trastuzumab | RT + Paclitaxel + Carboplatin | III | DFS |
5-FU: 5-fluorouracil, OS: overall survival, PFS: progression-free survival, RT: radiotherapy, iv: intravenous, pCR: pathological complete response, DFS: disease free survival.