29
Participants
Start Date
December 3, 2018
Primary Completion Date
August 31, 2025
Study Completion Date
August 31, 2025
Paclitaxel
50 mg/m2 given by intravenous infusion on days 1, 8, 15, 22 and 29.
Carboplatin
Carboplatin AUC = 2 given by intravenous infusion on days 1, 8, 15, 22 and 29.
Dexamethasone
All patients receiving Paclitaxel will receive institutional standard premedications, which include Dexamethasone (10 mg IVPB)
Diphenhydramine
All patients receiving Paclitaxel will receive institutional standard premedications, which include diphenhydramine (50mg IVP)
Famotidine
All patients receiving Paclitaxel will receive institutional standard premedications, which include Famotidine (20mg IVPB)
Palonosetron
All patients receiving Paclitaxel will receive institutional standard premedications, which include Palonosetron (0.25mg IVP)
3D conformal or intensity modulated radiotherapy
Treatment will be given 5 days per week. Photon beams \>6 MV are required. Treatment may be delivered either by a 3D conformal technique or IMRT. IMRT via dynamically moving MLCs, step-and-shoot with a multileaf collimator, Rapid Arc, binary multileaf collimator, and tomotherapy are allowed. Proton therapy is not allowed.
Surgical resection
Surgical resection will constitute subtotal or total gastrectomy (depending on tumor size and location) and D2 lymphadenectomy.
Adjuvant Chemotherapy
The patient will begin adjuvant chemotherapy 4-12 weeks after surgery. The adjuvant chemotherapy will consist of FOLFOX every 2 weeks for 6 cycles (i.e. 3 months)
RECRUITING
Mount Sinai West, New York
RECRUITING
Mount Sinai St. Luke's, New York
RECRUITING
Icahn School of Medicine at Mount Sinai, New York
Icahn School of Medicine at Mount Sinai
OTHER