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AzTrials

Gastric CancerPhase 2NCT04308837

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

A Phase 2 study testing Paclitaxel, Carboplatin and Dexamethasone in people with Gastric Cancer and Stomach Cancer, run by Icahn School of Medicine at Mount Sinai at 3 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer, Stomach Cancer
What is being tested?
Paclitaxel, Carboplatin and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
3 sitesUnited States
Study dates
3 Dec 2018to Aug 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

3 sites in 1 country.

Spiros Hiotis, MD, PhD contact

(212) 241-2891

spiros.hiotis@mountsinai.org

United States3 sites, 3 recruiting

  • Mount Sinai West

    New York, New York, 10019

    Recruiting

  • Mount Sinai St. Luke's

    New York, New York, 10025

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    Recruiting

Other trials in United States

About this study

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

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.

Being tested
Paclitaxel, Carboplatin, Dexamethasone, Diphenhydramine, Famotidine
Keywords
Phase II Trial, HIPEC, Chemoradiation
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PaclitaxelDrug

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

  • CarboplatinDrug

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

  • DexamethasoneDrug

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

  • DiphenhydramineDrug

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

  • FamotidineDrug

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

  • PalonosetronDrug

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

  • 3D conformal or intensity modulated radiotherapyRadiation

    Also called IMRT

    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.

  • Surgical resectionProcedure or surgery

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

  • Adjuvant ChemotherapyRadiation

    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)

Study groups in NCT04308837
Study groupRoleWhat they receive
Patients With Local Regional Advanced Gastric CancerExperimentalPatients 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: at time of surgical resection

Secondary outcomes (3)

  1. Overall Survival (OS)

    OS is defined as the time from the first dose of study treatment to the date of death (whatever the cause).

    Measured: 6 years

  2. Disease-free Survival

    The length of time after treatment ends that the patient survives without any signs or symptoms.

    Measured: 6 years

  3. Peritoneal Disease-free Survival

    The length of time after treatment ends that the patient survives without any peritoneal signs or symptoms.

    Measured: 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2020
  2. Study start3 Dec 2018
  3. Primary completionAug 2025 (estimated)
  4. Study completionAug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
The study design involves a single arm of patients that will all receive the same treatment.
Masking
None (open label)
Enrolment
29 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04308837
Sponsor's protocol ID
GCO 18-1101
Status last verified
Nov 2023
First submitted
12 Mar 2020
Last updated
14 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel, Carboplatin and Dexamethasone in people with Gastric Cancer and Stomach Cancer, run by Icahn School of Medicine at Mount Sinai at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Spiros Hiotis, MD, PhD ((212) 241-2891, spiros.hiotis@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological Response (time frame: at time of surgical resection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04308837.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.

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