NCT04308837

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

A Phase II Trial of Neoadjuvant Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Chemoradiation (Carboplatin and Taxol) as First Line Treatment for Patients With Local Regional Advanced Gastric Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2018-12-03
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2020-03-16
• Last updated: 2023-11-14

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study