Gastric AdenocarcinomaPhase 2/3STOPGAP IINCT07001748
Testing the Addition of Paclitaxel Administered Into the Abdominal Cavity Combined With Chemotherapy for Patients With Gastric Cancer Spread to the Abdominal Cavity
A Phase 2/3 study testing Biospecimen Collection, Computed Tomography and Diagnostic Laparoscopy in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by ECOG-ACRIN Cancer Research Group at 78 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Peritoneal Carcinomatosis
- What is being tested?
- Biospecimen Collection, Computed Tomography and Diagnostic Laparoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 78 sitesUnited States
- Study dates
- 24 Oct 2025to 30 May 2031
- Phase
- Phase 2/3
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
STEP 0 REGISTRATION:
- Patient must be at least 18 years of age
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Patient must have histologically or cytologically confirmed microsatellite stable (MSS) or mismatch repair (MMR) protein expression proficient primary gastric or gastroesophageal adenocarcinoma (Siewert 3) with synchronous cytology positive disease (cyt+) OR peritoneal carcinomatosis detected by imaging, laparoscopy or laparotomy. Patients with microsatellite instability-high (MSI-H/dMMR) mismatch repair deficient disease are not eligible
- Patient must have received a minimum of 3 months and a maximum of 6 months of first line systemic treatment
- Patient must be registered to Step 0 within 4 weeks of the last dose of first line systemic therapy. Patient must not have any ongoing significant adverse events that would prohibit them from undergoing a diagnostic laparoscopy procedure followed by further systemic and intraperitoneal therapy
- Patient must have no evidence of small or large bowel obstruction other than gastric outlet obstruction due to primary malignancy
- Patient must have no evidence of solid organ metastases except for ovarian metastases. Baseline imaging must be done within 30 days prior to Step 0 registration
- Patient must have no evidence of clinically significant radiologic peritoneal disease progression during first line systemic therapy
- Patient must have no evidence of extensive retroperitoneal lymph node metastases not amenable to resection during gastrectomy
- Patient must have no history of prior surgery that would preclude safe diagnostic laparoscopy and port placement
- Patient must have no evidence of massive ascites on imaging or history of two therapeutic paracentesis with drainage of more than 1.0 liter of ascites each time in 30 days prior to Step 0 registration
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better
- Patient must not have any uncontrolled intercurrent illness or any other significant condition(s) that would make this protocol unreasonably hazardous
- Patient must not have any known contraindications or drug allergies to the protocol treatment agents: paclitaxel, 5-fluorouracil, or leucovorin
- Leukocytes ≥ 2,000/uL (≤ 30 days prior to Step 0 registration)
- Absolute neutrophil count (ANC) ≥ 1,500/uL (≤ 30 days prior to Step 0 registration)
- Platelets ≥ 75,000/uL (≤ 30 days prior to Step 0 registration)
- Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN). If patient has Gilbert's syndrome, total bilirubin must be < 2.0 mg/dL (≤ 30 days prior to Step 0 registration)
- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase [SGPT]) ≤ 3.0 x institutional ULN (≤ 30 days prior to Step 0 registration)
- Creatinine clearance ≥ 30 mL/min (estimated using Cockcroft and Gault formula or measured) (≤ 30 days prior to Step 0 registration)
- Hemoglobin ≥ 8 g/dL (≤ 30 days prior to Step 0 registration)
- Serum albumin ≥ 2.5 g/dL (≤ 30 days prior to Step 0 registration)
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of Step 0 registration are eligible for this trial
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used
- All patients of childbearing potential must have a blood test or urine study within 14 days prior to Step 0 registration to rule out pregnancy
- A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
- Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception (or by abstaining from sexual intercourse) for the duration of their participation in the study. Arm A patients must adhere to the contraceptive requirements outlined in the product specific package inserts while on protocol treatment. Arm B patients must continue contraceptive measures for at least 3 months after the last dose of protocol treatment. In addition, both Arm A and Arm B patients who continue with targeted agents must adhere to the contraceptive requirements outlined in the product specific package inserts while on protocol treatment
- Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
STEP 1 RANDOMIZATION:
- Patient must have undergone a diagnostic laparoscopy with peritoneal lavage performed and aspiration for cytology obtained
- The extent of peritoneal disease burden must have been assessed during the diagnostic laparoscopy with the Peritoneal Cancer Index (PCI) available
- Patient must not have extensive intraabdominal adhesions that preclude safe placement of the intraperitoneal port
Trial locations and contacts
78 sites in 1 country. Contact the study team or a site near you to ask about taking part.
78 sites in 1 country
United States78 sites, 78 recruiting
- Recruiting
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu
Alissa Greenbaum
- Recruiting
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Site Public Contact, 800-865-1125, CancerAnswerLine@med.umich.edu
Thomas Enzler
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Site Public Contact, 888-946-7447
Seth Concors
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Site Public Contact, 404-778-1868
Seth Concors
- Recruiting
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Site Public Contact, 404-851-7115
Seth Concors
- Recruiting
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045
Site Public Contact, 720-848-0650
Sunnie S. Kim
- Recruiting
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
Site Public Contact, 800-888-8823
Jeremy L. Davis
- Recruiting
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Site Public Contact, 212-639-7592
George Z. Li
- Recruiting
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Site Public Contact, 877-668-0683, cancerclinicaltrials@med.unc.edu
Ashwin Somasundaram
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Site Public Contact, 312-695-1301, cancer@northwestern.edu
Brett L. Ecker
- Recruiting
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Mecker G. Moller
- Recruiting
Northwestern Medicine Cancer Center Old Irving Park
Chicago, Illinois, 60641
Site Public Contact, nctnprogram_rhlccc@northwestern.edu
Brett L. Ecker
- Recruiting
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Ramon Jin
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Site Public Contact, 800-293-5066, Jamesline@osumc.edu
Pamela W. Lu
- Recruiting
Memorial Sloan Kettering Commack
Commack, New York, 11725
Site Public Contact, 212-639-7592
George Z. Li
- Recruiting
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Ramon Jin
- Recruiting
Parkland Memorial Hospital
Dallas, Texas, 75235
Site Public Contact, 214-590-5582, canceranswerline@UTSouthwestern.edu
Alex C. Kim
- Recruiting
UT Southwestern Simmons Cancer Center - RedBird
Dallas, Texas, 75237
Site Public Contact, 214-648-7097, canceranswerline@utsouthwestern.edu
Alex C. Kim
- Recruiting
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu
Alex C. Kim
- Recruiting
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Brett L. Ecker
- Recruiting
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, 06418
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Raghav Sundar
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
Site Public Contact, 313-916-3721, CTOResearch@hfhs.org
Rupen Shah
- Recruiting
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, 06824
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Raghav Sundar
- Recruiting
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
Site Public Contact, 701-234-6161, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas, 76104
Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu
Alex C. Kim
- Recruiting
UF Health Cancer Institute - Gainesville
Gainesville, Florida, 32610
Site Public Contact, 352-273-8010
Lakshmi Balasubramanian
- Recruiting
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Brett L. Ecker
- Recruiting
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, 06830
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Raghav Sundar
- Recruiting
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, 06437
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Raghav Sundar
- Recruiting
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Site Public Contact, 212-639-7592
George Z. Li
- Recruiting
University of North Carolina-Hillsborough Campus
Hillsborough, North Carolina, 27278
Site Public Contact, 877-668-0683, cancerclinicaltrials@med.unc.edu
Ashwin Somasundaram
- Recruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612
Site Public Contact, 877-827-8839, ucstudy@uci.edu
Maheswari Senthil
- Recruiting
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
Site Public Contact, 859-257-3379
Prakash K. Pandalai
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Site Public Contact, 310-423-2133, Cancer.trial.info@cshs.org
Alexandra Gangi
- Recruiting
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, 53718
Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu
Nataliya V. Uboha
- Recruiting
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu
Nataliya V. Uboha
- Recruiting
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Rohit Sharma
- Recruiting
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051
Site Public Contact, 262-257-5100
Ugwuji N. Maduekwe
- Recruiting
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Site Public Contact, 212-639-7592
George Z. Li
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Site Public Contact, 414-805-3666
Ugwuji N. Maduekwe
- Recruiting
NYU Langone Hospital - Long Island
Mineola, New York, 11501
Site Public Contact, 212-263-4432, cancertrials@nyulangone.org
Zachary J. Brown
- Recruiting
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Site Public Contact, 212-639-7592
George Z. Li
- Recruiting
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Site Public Contact, 800-811-8480
Deepa Magge
- Recruiting
Froedtert and MCW Moorland Reserve Health Center
New Berlin, Wisconsin, 53151
Site Public Contact, 414-805-0505
Ugwuji N. Maduekwe
- Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Site Public Contact, 732-235-7356
Haejin In
- Recruiting
Yale University
New Haven, Connecticut, 06520
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Raghav Sundar
- Recruiting
University Medical Center New Orleans
New Orleans, Louisiana, 70112
Site Public Contact, 504-210-3539, emede1@lsuhsc.edu
Kevin M. Sullivan
- Recruiting
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016
Site Public Contact, CancerTrials@nyulangone.org
Zachary J. Brown
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Site Public Contact, 212-639-7592
George Z. Li
- Recruiting
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, 06473
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Raghav Sundar
- Recruiting
Northwestern Medicine Oak Brook
Oak Brook, Illinois, 60523
Site Public Contact, nctnprogram_rhlccc@northwestern.edu
Brett L. Ecker
- Recruiting
Drexel Town Square Health Center
Oak Creek, Wisconsin, 53154
Site Public Contact, 414-805-0505
Ugwuji N. Maduekwe
- Recruiting
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868
Site Public Contact, 877-827-8839, ucstudy@uci.edu
Maheswari Senthil
- Recruiting
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304
Site Public Contact, 650-498-7061, ccto-office@stanford.edu
Byrne Lee
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu
Nader Hanna
- Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Site Public Contact, 412-647-8073
Mohammad Haroon A. Choudry
- Recruiting
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, 15237
Site Public Contact, 412-367-6454
Mohammad Haroon A. Choudry
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Site Public Contact, 503-494-1080, trials@ohsu.edu
Divya Sood
- Recruiting
UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas, 75080
Site Public Contact, 972-669-7044, Suzanne.cole@utsouthwestern.edu
Alex C. Kim
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Site Public Contact, 855-776-0015
Travis E. Grotz
- Recruiting
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
Site Public Contact, 888-424-2100, cancerinfo@hci.utah.edu
Erin P. Ward
- Recruiting
Memorial Hospital East
Shiloh, Illinois, 62269
Site Public Contact, 314-747-9912, dschwab@wustl.edu
Ramon Jin
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Ramon Jin
- Recruiting
Siteman Cancer Center-South County
St Louis, Missouri, 63129
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Ramon Jin
- Recruiting
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Ramon Jin
- Recruiting
Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut, 06902
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Raghav Sundar
- Recruiting
Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut, 06790
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Raghav Sundar
- Recruiting
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, 06611
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Raghav Sundar
- Recruiting
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
Site Public Contact, 212-639-7592
George Z. Li
- Recruiting
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Brett L. Ecker
- Recruiting
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut, 06708
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Raghav Sundar
- Recruiting
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, 06385
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Raghav Sundar
- Recruiting
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, 53095
Site Public Contact, 414-805-0505
Ugwuji N. Maduekwe
- Recruiting
Smilow Cancer Hospital Care Center - Westerly
Westerly, Rhode Island, 02891
Site Public Contact, 203-785-5702, canceranswers@yale.edu
Raghav Sundar
- Recruiting
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Rohit Sharma
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Site Public Contact, 336-713-6771
Edward A. Levine
About this study
Official title: Protocol EA2234: A Randomized Phase II/III Trial of Intraperitoneal Paclitaxel Plus Systemic Treatment vs Systemic Treatment Alone in Gastric Carcinomatosis - STOPGAP II
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.
Read more
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.
Read the detailed description
PRIMARY OBJECTIVES:
- In the phase II portion, to determine the progression free survival (PFS) from randomization.
II. In the phase III portion, to determine overall survival (OS) from randomization.
SECONDARY OBJECTIVE:
- To compare the safety and tolerability of the intraperitoneal chemotherapy + systemic therapy regimen vs the systemic therapy alone regimen.
OUTLINE:
STEP 0: Patients undergo diagnostic laparoscopy within 4 weeks of study registration.
STEP 1: Patients are randomized to 1 of 2 arms at the time of Step 0 diagnostic laparoscopy.
ARM A: Patients receive standard of care systemic therapy per physician's choice. Patients with stable disease or a response after 12 weeks may continue to receive standard of care treatment in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection and computed tomography (CT) and/or magnetic resonance imaging (MRI) throughout the study and may undergo additional diagnostic laparoscopies as clinically indicated.
ARM B: Patients undergo placement of an intraperitoneal port. Patients receive leucovorin calcium intravenously (IV) over 15-30 minutes, fluorouracil IV push, paclitaxel IV over 1-2 hours and paclitaxel intraperitoneally (IP) on days 1 and 8 of each cycle. Cycles repeat every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease or a response after 12 weeks may continue to receive treatment in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection and CT and/or MRI throughout the study and may undergo additional diagnostic laparoscopies as clinically indicated.
After completion of study treatment, patients are followed up every 3 months for 2 years then every 6 months for up to 5 years after Step 1 randomization.
- Conditions
- Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Peritoneal Carcinomatosis
- Being tested
- Standard of Care Chemotherapy, Biospecimen Collection, Computed Tomography, Diagnostic Laparoscopy, Intraperitoneal Port Placement
- Keywords
- EA2234, Intraperitoneal Paclitaxel, STOPGAP II, STOPGAP I, Gastric Carcinomatosis
- Medical subject headings
- Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care ChemotherapyDrug
Also called best practice, standard of care, standard therapy
The most common regimens are FOLFOX, CAPOX, FLOT, CF, and CX. Other local institutional standard of care regimens as well as targeted agents for gastric/GEJ adenocarcinoma are allowed.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Plasma is to be submitted at baseline and every three months for the first year or until progression, whichever comes first. For patients who have progression, their last plasma sample should be at time of progression.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Restaging imaging with CT and/or diffusion weighted MRI with contrast will be obtained after completion of 12 weeks (+/- 2 weeks) of assigned treatment (restaging will occur at this timepoint, regardless of if the patient completed all 4 cycles or not). At this point, patients with stable disease or a response will continue assigned treatment. In the absence of radiological or clinical progression, if clinically indicated by treatment team, patients may undergo diagnostic laparoscopy to assess surgical candidacy at which time a PCI assessment and biopsies of peritoneal nodules, peritoneal lavage could be performed. Cytoreduction can be offered to patients with a PCI < 7 and if complete cytoreduction is feasible based on treating surgeon's discretion. If deemed a candidate for surgical cytoreduction, surgery should be performed within 6 weeks of the last study treatment in both arms.
Diagnostic LaparoscopyProcedure or surgery
After induction of general anesthesia, administration of preoperative antibiotics and placement of appropriate laparoscopic ports, peritoneal lavage will be performed by instillation of 200 ml of normal saline in the left upper quadrant and allowed to dwell for 5 minutes after which it will be aspirated for cytology. Extent of peritoneal disease burden will be ascertained as per the Peritoneal Cancer Index (PCI) scoring system as outlined in Appendix V.
Intraperitoneal Port PlacementProcedure or surgery
Patients assigned to Arm B will undergo placement of indwelling tunneled intraperitoneal port with Teflon cuff following Step 1 randomization and during the diagnostic laparoscopy procedure.
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Restaging imaging with CT and/or diffusion weighted MRI with contrast will be obtained after completion of 12 weeks (+/- 2 weeks) of assigned treatment (restaging will occur at this timepoint, regardless of if the patient completed all 4 cycles or not). At this point, patients with stable disease or a response will continue assigned treatment. In the absence of radiological or clinical progression, if clinically indicated by treatment team, patients may undergo diagnostic laparoscopy to assess surgical candidacy at which time a PCI assessment and biopsies of peritoneal nodules, peritoneal lavage could be performed. Cytoreduction can be offered to patients with a PCI < 7 and if complete cytoreduction is feasible based on treating surgeon's discretion. If deemed a candidate for surgical cytoreduction, surgery should be performed within 6 weeks of the last study treatment in both arms.
Intraperitoneal PaclitaxelDrug
Patients on Arm B will start systemic therapy + intraperitoneal paclitaxel as early as the day after Step 1 randomization and must start within 30 calendar days (including holidays) after Step 1 randomization as per the schedule shown in the table below.
Therapy will be administered on Days 1 and 8 of a 21-day cycle for 4 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Step 1, Arm A (standard systemic therapy) | Active comparator | Patients on Arm A will start systemic therapy with physician's choice of any standard-of-care systemic regimen for gastric/GEJ adenocarcinoma. Patients on Arm A will start systemic therapy as early as the day after Step 1 randomization and must start within 30 calendar days (including holidays) after Step 1 randomization. After 12 weeks (+/- 2 weeks) of standard of care treatment, patients will undergo a restaging assessment as outlined in Section 5.2 (restaging will occur at this timepoint, regardless of if the patient completed all 4 cycles or not). Patients who are found to have stable disease or a response may continue assigned standard of care treatment and will undergo restaging every 12 weeks (+/- 2 weeks) as outlined in Section 5.2. Treatment will continue until progression (radiographic progression or clinical progression as defined in Section 6), intolerance (unacceptable toxicity), or cytoreduction. Receives: Drug: Standard of Care Chemotherapy; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Diagnostic Laparoscopy; Procedure: Magnetic Resonance Imaging |
| Step 1, Arm B (Systemic Therapy + Intraperitoneal Paclitaxel) | Experimental | Patients on Arm B will start systemic therapy + intraperitoneal paclitaxel as early as the day after Step 1 randomization and must start within 30 calendar days (including holidays) after Step 1 randomization.
Therapy will be administered on Days 1 and 8 of a 21-day cycle for 4 cycles. After 12 weeks (+/- 2 weeks) of study treatment, patients will undergo restaging assessments as outlined in Section 5.2 (restaging will occur at this timepoint, regardless of if the patient completed all 4 cycles or not). Patients who are found to have stable disease or a response may continue assigned protocol treatment and will undergo restaging every 12 weeks (+/- 2 weeks) as outlined in Section 5.2. Treatment will continue until progression (radiographic progression or clinical progression as defined in Section 6), intolerance (unacceptable toxicity), or cytoreduction. Receives: Drug: Standard of Care Chemotherapy; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Diagnostic Laparoscopy; Procedure: Intraperitoneal Port Placement; Procedure: Magnetic Resonance Imaging; Drug: Intraperitoneal Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (Phase II)
For the Phase II portion, full information is expected to occur 12 months after accrual or 38 months after study activation. This power calculation is based on a stratified log rank test and accounts for a planned interim analysis at 50% information time. At 50% information time, futility test using Wieand rule would be conducted. If the study results show promising results for the investigational arm and reject the null hypothesis at interim efficacy analysis, the study will proceed to investigate Phase III portion without having a pause in accrual before starting Phase III. Otherwise, if the study is not futile at 50% information time (HR>1), then the study will proceed and wait for the data to reach 100% information, meaning that the study will wait until the data is mature for Phase II analysis (projected to wait 12 months after end of the accrual to collect 58 PFS events).
Measured: From randomization to progression or death without documentation of progression, assessed up to 5 years.
Overall survival (Phase III)
For the Phase III portion, a futility interim analysis is planned at 50% information time, projected to occur 4.3 years after study activation. However, because of the potential one year pause before starting Phase III portion, the futility interim analysis may occur early. Similar to the Phase II portion, the interim analysis for futility would use the Wieand rule to make sure the investigational arm is not doing worse than the control arm. For efficacy, interim analysis would start at 30% information time and be conducted every 6 months subsequently accordingly with the DSMC monitoring schedule. Approximately 1.5 additional years after completion of accrual, the OS analysis will reach 100% information time with 105 OS events.
Measured: From randomization to the date of death, of any cause, assessed up to 5 years
Secondary outcomes (1)
Incidence of adverse events
Safety and tolerability will be assessed by counting treatment-related grade 3 or higher toxicity events of the patients.
Measured: Up to 30 days after the last day of protocol treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start24 Oct 2025
- Primary completion30 May 2030 (estimated)
- Study completion30 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by ECOG-ACRIN Cancer Research GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Maheswari Senthil, Principal investigator, ECOG-ACRIN Cancer Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001748
- Sponsor's protocol ID
- EA2234
- Other IDs
- U10CA180820, NCI-2025-01831, EA2234, EA2234
- Acronym
- STOPGAP II
- Status last verified
- Oct 2026
- First submitted
- 23 May 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided