RecruitingPhase II/IIIEN originalGastric cancerMetastatic / advanced

Testing the Addition of Paclitaxel Administered Into the Abdominal Cavity Combined With Chemotherapy for Patients With Gastric Cancer Spread to the Abdominal Cavity

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

This study is being done to answer the following questions: Can we lower the chance of your gastric cancer from growing or spreading by administering paclitaxel chemotherapy directly into your abdominal cavity in addition to chemotherapy given through a vein in your arm? Will administering paclitaxel chemotherapy directly into your abdominal cavity, in addition to chemotherapy given through a vein in your arm help you live longer? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your gastric cancer. The usual approach is defined as care most people get for gastric cancer. If you decide to take part in this study, you will first receive a surgical procedure called a diagnostic laparoscopy. This will help the study doctors learn more about your gastric cancer. Laparoscopy is a minimally invasive surgery for which you will be placed under general anesthesia. Then the surgeon will make small incisions (5mm) on your belly through which a camera and thin instruments are introduced to evaluate the abdomen. This procedure takes about 1 hour to complete. Your study group will be assigned during the surgery. The study groups are described further in the 'What are the study groups?' section below. If you are placed into the study group 1, you will not have an intraperitoneal port (a small device which is placed under the skin and fat of your upper abdomen and a tube that is placed into the abdomen). If you are placed into the study group 2, you will have an intraperitoneal port placed. The reason is that in addition to standard chemotherapy, which is given through a vein in your arm, this port will be used to deliver the medication paclitaxel directly inside your abdomen when you are ready to start study treatment. It is important to know that you will not know your study group until after the surgery is over. This is because information that is learned during the surgery will help determine which study group you are put in. Once you have fully healed from this surgery, you will start study treatment. Depending on which study group you are assigned, you will either receive a standard chemotherapy regimen (the regimen will be chosen by you and your doctor) if you are in study group 1, or paclitaxel through a tube in your belly plus chemotherapy given through a vein in your arm if you are in study group 2. All participants will get treatment for three (3) months after which you will undergo reevaluation. If the disease is under control or responding to treatment, you may continue the assigned treatment until your disease gets worse, the side effects become too severe, or you may be offered a surgical procedure to remove the cancer if the amount of disease is low and can be completely removed as determined by a surgeon. There is a very small chance that during the laparoscopy surgical procedure, the doctor might find something called "intra-abdominal adhesions". These are areas where the stomach has healed previously and created scar tissue. If this scar tissue prevents the surgeon from being able to place a port in the correct area, you would be ineligible to receive the study treatment. If this happens, you may still receive standard of care therapy after your surgery, but you will not be able to continue on the study. If you have more questions about this, you can ask your surgeon or the study team to help. After you finish your study treatment, your doctor or study team will watch you for side effects. They will continue to follow your condition every three (3) months during the first two (2) years, then every six (6) months until year 5. You may be reevaluated with Chest/Abdomen/Pelvis scans every three-six (3-6) months for up to five (5) years if decided by your doctor.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Wiek co najmniej 18 lat
  • Potwierdzony przez badanie histologiczne rak żołądka lub złączenia przełyku ze żołądkiem
  • Przebycie chemioterapii I linii przez minimum 3 miesiące, maksymalnie 6 miesięcy
  • Rejestracja do badania w ciągu 4 tygodni po ostatniej dawce chemioterapii I linii
  • Możliwość bezpiecznego wykonania procedury diagnostycznej i dalszego leczenia
  • Brak przeszkód zdrowotnych do wykonania badania laparoskopowego

✗ Disqualifies

  • Przerzuty do narządów wewnętrznych inne niż jajniki
  • Niedrożność jelita cienkog lub grubego (poza zwężeniem ujścia żołądka)
  • Masywny wylew płynu w jamie brzusznej
  • Rozległe przerzuty węzłów chłonnych w retroperitoneum
  • Historia poprzedniej operacji uniemożliwiająca diagnostyczną laparoskopię
  • Zaburzenia czynności serca lub poprzednie leczenie lekami kardiotropowymi

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
August 19, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (78)

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, United States

Cedars-Sinai Medical Center

Los Angeles, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, United States

Stanford Cancer Institute Palo Alto

Palo Alto, United States

UCHealth University of Colorado Hospital

Aurora, United States

Smilow Cancer Hospital-Derby Care Center

Derby, United States

Smilow Cancer Hospital Care Center-Fairfield

Fairfield, United States

Smilow Cancer Hospital Care Center at Greenwich

Greenwich, United States

Smilow Cancer Hospital Care Center - Guilford

Guilford, United States

Yale University

New Haven, United States

Yale-New Haven Hospital North Haven Medical Center

North Haven, United States

Smilow Cancer Hospital Care Center at Long Ridge

Stamford, United States

Smilow Cancer Hospital-Torrington Care Center

Torrington, United States

Smilow Cancer Hospital Care Center-Trumbull

Trumbull, United States

Smilow Cancer Hospital-Waterbury Care Center

Waterbury, United States

Smilow Cancer Hospital Care Center - Waterford

Waterford, United States

UF Health Cancer Institute - Gainesville

Gainesville, United States

Emory University Hospital Midtown

Atlanta, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, United States

Emory Saint Joseph's Hospital

Atlanta, United States

Northwestern University

Chicago, United States

University of Chicago Comprehensive Cancer Center

Chicago, United States

Northwestern Medicine Cancer Center Old Irving Park

Chicago, United States

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, United States

Northwestern Medicine Cancer Center Delnor

Geneva, United States

Northwestern Medicine Oak Brook

Oak Brook, United States

Memorial Hospital East

Shiloh, United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, United States

University of Kentucky/Markey Cancer Center

Lexington, United States

University Medical Center New Orleans

New Orleans, United States

University of Maryland/Greenebaum Cancer Center

Baltimore, United States

University of Michigan Rogel Cancer Center

Ann Arbor, United States

Henry Ford Hospital

Detroit, United States

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, United States

West Michigan Cancer Center

Kalamazoo, United States

Mayo Clinic in Rochester

Rochester, United States

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, United States

Siteman Cancer Center at West County Hospital

Creve Coeur, United States

Washington University School of Medicine

St Louis, United States

Siteman Cancer Center-South County

St Louis, United States

Siteman Cancer Center at Christian Hospital

St Louis, United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, United States

Memorial Sloan Kettering Monmouth

Middletown, United States

Memorial Sloan Kettering Bergen

Montvale, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, United States

University of New Mexico Cancer Center

Albuquerque, United States

Memorial Sloan Kettering Commack

Commack, United States

Memorial Sloan Kettering Westchester

East White Plains, United States

NYU Langone Hospital - Long Island

Mineola, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, United States

Memorial Sloan Kettering Cancer Center

New York, United States

Memorial Sloan Kettering Nassau

Uniondale, United States

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, United States

University of North Carolina-Hillsborough Campus

Hillsborough, United States

Wake Forest University Health Sciences

Winston-Salem, United States

Sanford Roger Maris Cancer Center

Fargo, United States

Ohio State University Comprehensive Cancer Center

Columbus, United States

Oregon Health and Science University

Portland, United States

Thomas Jefferson University Hospital

Philadelphia, United States

UPMC Hillman Cancer Center

Pittsburgh, United States

UPMC-Passavant Hospital

Pittsburgh, United States

Smilow Cancer Hospital Care Center - Westerly

Westerly, United States

Vanderbilt University/Ingram Cancer Center

Nashville, United States

Parkland Memorial Hospital

Dallas, United States

UT Southwestern Simmons Cancer Center - RedBird

Dallas, United States

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, United States

UT Southwestern/Simmons Cancer Center-Fort Worth

Fort Worth, United States

UT Southwestern Clinical Center at Richardson/Plano

Richardson, United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, United States

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, United States

Marshfield Medical Center-Marshfield

Marshfield, United States

Froedtert Menomonee Falls Hospital

Menomonee Falls, United States

Medical College of Wisconsin

Milwaukee, United States

Froedtert and MCW Moorland Reserve Health Center

New Berlin, United States

Drexel Town Square Health Center

Oak Creek, United States

Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, United States

Marshfield Medical Center - Weston

Weston, United States

Trial contact

Site Public Contact

Maheswari Senthil

PRINCIPAL_INVESTIGATOR

Alexandra Gangi

PRINCIPAL_INVESTIGATOR

Byrne Lee

PRINCIPAL_INVESTIGATOR

Site Public Contact

Sunnie S. Kim

PRINCIPAL_INVESTIGATOR

Raghav Sundar

PRINCIPAL_INVESTIGATOR

Site Public Contact

Lakshmi Balasubramanian

PRINCIPAL_INVESTIGATOR

Site Public Contact

Seth Concors

PRINCIPAL_INVESTIGATOR

Site Public Contact

Site Public Contact

Brett L. Ecker

PRINCIPAL_INVESTIGATOR

Mecker G. Moller

PRINCIPAL_INVESTIGATOR

Ramon Jin

PRINCIPAL_INVESTIGATOR

Site Public Contact

Prakash K. Pandalai

PRINCIPAL_INVESTIGATOR

Kevin M. Sullivan

PRINCIPAL_INVESTIGATOR

Site Public Contact

Jeremy L. Davis

PRINCIPAL_INVESTIGATOR

Thomas Enzler

PRINCIPAL_INVESTIGATOR

Rupen Shah

PRINCIPAL_INVESTIGATOR

Kathleen Y. Butler

PRINCIPAL_INVESTIGATOR

Site Public Contact

Travis E. Grotz

PRINCIPAL_INVESTIGATOR

Site Public Contact

George Z. Li

PRINCIPAL_INVESTIGATOR

Site Public Contact

Haejin In

PRINCIPAL_INVESTIGATOR

Alissa Greenbaum

PRINCIPAL_INVESTIGATOR

Zachary J. Brown

PRINCIPAL_INVESTIGATOR

Site Public Contact

Ashwin Somasundaram

PRINCIPAL_INVESTIGATOR

Site Public Contact

Edward A. Levine

PRINCIPAL_INVESTIGATOR

Daniel Almquist

PRINCIPAL_INVESTIGATOR

Pamela W. Lu

PRINCIPAL_INVESTIGATOR

Site Public Contact

Divya Sood

PRINCIPAL_INVESTIGATOR

Nader Hanna

PRINCIPAL_INVESTIGATOR

Site Public Contact

Mohammad Haroon A. Choudry

PRINCIPAL_INVESTIGATOR

Site Public Contact

Site Public Contact

Deepa Magge

PRINCIPAL_INVESTIGATOR

Alex C. Kim

PRINCIPAL_INVESTIGATOR

Erin P. Ward

PRINCIPAL_INVESTIGATOR

Nataliya V. Uboha

PRINCIPAL_INVESTIGATOR

Rohit Sharma

PRINCIPAL_INVESTIGATOR

Site Public Contact

Ugwuji N. Maduekwe

PRINCIPAL_INVESTIGATOR

Site Public Contact

Site Public Contact

Contact information from ClinicalTrials.gov. Contact in English.

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Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/20/2026.

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