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

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ClinicalTrials.gov Identifier: NCT04308837
Recruitment Status : Recruiting
First Posted : March 16, 2020
Last Update Posted : March 16, 2020
Sponsor:
Information provided by (Responsible Party):
Spiros Hiotis, Icahn School of Medicine at Mount Sinai

Brief 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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Stomach Cancer Drug: Paclitaxel Drug: Carboplatin Drug: Dexamethasone Drug: Diphenhydramine Drug: Famotidine Drug: Palonosetron Radiation: 3D conformal or intensity modulated radiotherapy Procedure: Surgical resection Radiation: Adjuvant Chemotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: The study design involves a single arm of patients that will all receive the same treatment.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 31, 2018
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Patients With Local Regional Advanced Gastric Cancer
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.
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.
Other Name: IMRT

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)




Primary Outcome Measures :
  1. Pathological Response [ Time Frame: at time of surgical resection ]
    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)


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 6 years ]
    OS is defined as the time from the first dose of study treatment to the date of death (whatever the cause).

  2. Disease-free Survival [ Time Frame: 6 years ]
    The length of time after treatment ends that the patient survives without any signs or symptoms.

  3. Peritoneal Disease-free Survival [ Time Frame: 6 years ]
    The length of time after treatment ends that the patient survives without any peritoneal signs or symptoms.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of gastric cancer post endoscopic ultrasound (EUS), staging must be T3/T4
  • N0/+, M0. EUS must have been done within 8 weeks of the protocol start.
  • Patient must plan to undergo surgical treatment.
  • ECOG Scale of Performance Status of 0-2
  • Adequate organ and marrow function (leukocytes ≥ 3000/mcl, absolute neutrophil count ≥ 1500, platelets ≥ 100,000/mcl, total bilirubin ≥ 1.5mg/dl (Gilbert's syndrome, then <3.0), AST(SGOT)/ALT(SPGT) ≤ 2.5 X institutional upper limit of normal, creatinine within normal institutional limits)
  • Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

  • Subjects who have any previous treatment for their cancer.
  • Patients with known metastatic disease; this includes patients with clinically apparent or suspected metastasis to sites other than lymph nodes or peritoneal surfaces.
  • Subjects with early stage gastric cancer (Stage T1/T2 N0)
  • History of allergic reactions attributed to compounds of similar chemical or biological composition to any of the agents being used in this study, including but not limited to: Carboplatin, Taxol, 5-FU, Leucovorin, Mitomycin C.
  • Subjects who have received prior radiation to any portion of the abdominal cavity or pelvis are excluded.
  • Subjects who have had prior malignancies, except for cured non-melanoma skin cancer, or curatively treated in situ carcinoma of the cervix, or adequately treated malignancies for which there has been no evidence of activity for more than three years.
  • Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
  • Subjects with a condition that may interfere with the subjects' ability to understand the requirements of the study.
  • Known HIV, Hepatitis B, or Hepatitis C positive patients.
  • Patients with active coronary artery disease (defined as unstable angina or a positive cardiac stress test) will be excluded. Subjects with a history of coronary artery disease may be included if they have had a normal stress test within 30 days of enrollment.
  • Patients with restrictive or obstructive pulmonary disease that would limit study compliance or place the patient at unacceptable risk for participation in the study will be excluded.
  • Patients with a history of cerebrovascular disease that would limit study compliance or place the patient at unacceptable risk for participation in the study will be excluded.
  • Subjects with other concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study, or places them at an unacceptable risk for participation in the study, will also be excluded.
  • Evidence of extensive intraperitoneal adhesions at the time of surgery which prohibits intraperitoneal therapy, as determined by the operating surgeon.
  • Patients with any condition that would precluded the ability to deliver appropriate IP therapy.
  • Patients with a life expectancy of less than 12 weeks will be excluded from this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04308837


Contacts
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Contact: Margaret Hofstedt, BS 212-241-1474 margaret.hofstedt@mountsinai.org
Contact: Eliahu Bekhor 212-241-4365 eliahu.bekhor@mountsinai.org

Locations
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United States, New York
Mount Sinai West Recruiting
New York, New York, United States, 10019
Mount Sinai St. Luke's Recruiting
New York, New York, United States, 10025
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Spiros Hiotis, MD, PhD Icahn School of Medicine at Mount Sinai
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Responsible Party: Spiros Hiotis, Associate Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT04308837    
Other Study ID Numbers: GCO 18-1101
First Posted: March 16, 2020    Key Record Dates
Last Update Posted: March 16, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Spiros Hiotis, Icahn School of Medicine at Mount Sinai:
Phase II Trial
HIPEC
Chemoradiation
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Diphenhydramine
Promethazine
Dexamethasone
Paclitaxel
Carboplatin
Palonosetron
Famotidine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists