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

Summary

Stomach cancer is the fifth most common digestive cancer and third main cause of death from cancer in the world. Modern management of Gastric cancer involves a multi-disciplinary approach involving surgical oncologists, medical oncologists, gastroenterologists and oncological radiologists. The most common clinical approach to Gastric adenocarcinoma is to begin with staging, which usually involves CT scan/ MRI combined with endoscopic US for more accurate T, N staging. Once the patient is deemed to have locally advanced gastric cancer (T3/T4,N0/+), a staging laparoscopy is recommended to rule out obvious or microscopic peritoneal metastatic disease. Additionally, neoadjuvant chemotherapy is initiated and followed by surgery +/- adjuvant radiation and chemotherapy.This protocol involves the addition of neoadjuvant HIPEC at the time of diagnostic laparoscopy as well as neoadjuvant radiation therapy for improved local and systemic control. The goal of this phase II clinical trial is to evaluate the efficacy of a multi-modality approach to treating patients with locally advanced Gastric cancer by incorporating diagnostic laparoscopy with HIPEC, neo-adjuvant chemo-radiotherapy, followed by surgical resection and adjuvant chemotherapy. The trial aims to assess this multi-modality approach in inducing pathological complete response; decreased rates of disease progression during neoadjuvant therapy; and increased overall, disease-free, and peritoneal disease-free survival.

Conditions

• Gastric Cancer
• Stomach 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)

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai

  lead OTHER

Principal Investigators

• Spiros Hiotis, MD, PhD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-12-03

Primary Completion

2025-08-31

Completion

2025-08-31

FDA Drug

Yes

Countries

• United States

Study Locations