A Phase II Trial of Neoadjuvant Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Chemoradiation

PHASE2RecruitingINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

December 3, 2018

Primary Completion Date

August 31, 2025

Study Completion Date

August 31, 2025

Conditions
Gastric CancerStomach Cancer
Interventions
DRUG

Paclitaxel

50 mg/m2 given by intravenous infusion on days 1, 8, 15, 22 and 29.

DRUG

Carboplatin

Carboplatin AUC = 2 given by intravenous infusion on days 1, 8, 15, 22 and 29.

DRUG

Dexamethasone

All patients receiving Paclitaxel will receive institutional standard premedications, which include Dexamethasone (10 mg IVPB)

DRUG

Diphenhydramine

All patients receiving Paclitaxel will receive institutional standard premedications, which include diphenhydramine (50mg IVP)

DRUG

Famotidine

All patients receiving Paclitaxel will receive institutional standard premedications, which include Famotidine (20mg IVPB)

DRUG

Palonosetron

All patients receiving Paclitaxel will receive institutional standard premedications, which include Palonosetron (0.25mg IVP)

RADIATION

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.

PROCEDURE

Surgical resection

Surgical resection will constitute subtotal or total gastrectomy (depending on tumor size and location) and D2 lymphadenectomy.

RADIATION

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)

Trial Locations (3)

10019

RECRUITING

Mount Sinai West, New York

10025

RECRUITING

Mount Sinai St. Luke's, New York

10029

RECRUITING

Icahn School of Medicine at Mount Sinai, New York

All Listed Sponsors
lead

Icahn School of Medicine at Mount Sinai

OTHER