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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients With Local Regional Advanced Gastric Cancer | Experimental | Patients with local regional advanced gastric cancer after at least 4 weeks post diagnostic laparoscopy and HIPEC, will receive all of the treatments described in the study protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug | 50 mg/m2 given by intravenous infusion on days 1, 8, 15, 22 and 29. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological Response | The pathological complete response (the lack of all signs of cancer in tissue samples), at the time of surgical resection. This will be determined using a four-category tumor regression score system that evaluates the response of the cancer cells to the treatment. RECIST - Complete Response (CR), Partial Response (PR) Progressive Disease (PD), and Stable Disease (SD) | at time of surgical resection |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from the first dose of study treatment to the date of death (whatever the cause). | 6 years |
| Disease-free Survival | The length of time after treatment ends that the patient survives without any signs or symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Spiros Hiotis, MD, PhD | Contact | (212) 241-2891 | spiros.hiotis@mountsinai.org |
| Name | Affiliation | Role |
|---|---|---|
| Spiros Hiotis, MD, PhD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai West | Recruiting | New York | New York | 10019 | United States | |
| Mount Sinai St. Luke's |
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The study design involves a single arm of patients that will all receive the same treatment.
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| Carboplatin | Drug | Carboplatin AUC = 2 given by intravenous infusion on days 1, 8, 15, 22 and 29. |
|
| Dexamethasone | Drug | All patients receiving Paclitaxel will receive institutional standard premedications, which include Dexamethasone (10 mg IVPB) |
|
| Diphenhydramine | Drug | All patients receiving Paclitaxel will receive institutional standard premedications, which include diphenhydramine (50mg IVP) |
|
| Famotidine | Drug | All patients receiving Paclitaxel will receive institutional standard premedications, which include Famotidine (20mg IVPB) |
|
| Palonosetron | Drug | All patients receiving Paclitaxel will receive institutional standard premedications, which include Palonosetron (0.25mg IVP) |
|
| 3D conformal or intensity modulated radiotherapy | Radiation | 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. |
|
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| Surgical resection | Procedure | Surgical resection will constitute subtotal or total gastrectomy (depending on tumor size and location) and D2 lymphadenectomy. |
|
| Adjuvant Chemotherapy | Radiation | 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) |
|
| 6 years |
| Peritoneal Disease-free Survival | The length of time after treatment ends that the patient survives without any peritoneal signs or symptoms. | 6 years |
| Recruiting |
| New York |
| New York |
| 10025 |
| United States |
| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| D003907 | Dexamethasone |
| D004155 | Diphenhydramine |
| D015738 | Famotidine |
| D000077924 | Palonosetron |
| D020266 | Radiotherapy, Conformal |
| D050397 | Radiotherapy, Intensity-Modulated |
| D017024 | Chemotherapy, Adjuvant |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D005021 | Ethylamines |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D003131 | Combined Modality Therapy |
| D004358 | Drug Therapy |
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