Testa tillsatsen av paklitaxel administrerad i bukhålan i kombination med kemoterapi för patienter med gastrisk cancer spridd till bukhålan (STOPGAP II)
Protokoll EA2234: En randomiserad fas II/III -studie av intraperitoneal paklitaxel plus systemisk behandling mot systemisk behandling ensam i gastrisk karcinomatos - 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.
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.
Studieöversikt
Status
Detaljerad beskrivning
PRIMARY OBJECTIVES:
I. 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:
I. 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.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
- Fas 3
Kontakter och platser
Studieorter
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California
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Irvine, California, Förenta staterna, 92612
- Rekrytering
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
-
Kontakt:
- Site Public Contact
- Telefonnummer: 877-827-8839
- E-post: ucstudy@uci.edu
-
Huvudutredare:
- Maheswari Senthil
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Los Angeles, California, Förenta staterna, 90048
- Rekrytering
- Cedars-Sinai Medical Center
-
Huvudutredare:
- Alexandra Gangi
-
Kontakt:
- Site Public Contact
- Telefonnummer: 310-423-2133
- E-post: Cancer.trial.info@cshs.org
-
Orange, California, Förenta staterna, 92868
- Rekrytering
- UC Irvine Health/Chao Family Comprehensive Cancer Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 877-827-8839
- E-post: ucstudy@uci.edu
-
Huvudutredare:
- Maheswari Senthil
-
Palo Alto, California, Förenta staterna, 94304
- Rekrytering
- Stanford Cancer Institute Palo Alto
-
Kontakt:
- Site Public Contact
- Telefonnummer: 650-498-7061
- E-post: ccto-office@stanford.edu
-
Huvudutredare:
- Byrne Lee
-
-
Colorado
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Aurora, Colorado, Förenta staterna, 80045
- Rekrytering
- UCHealth University of Colorado Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 720-848-0650
-
Huvudutredare:
- Sunnie S. Kim
-
-
Connecticut
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Derby, Connecticut, Förenta staterna, 06418
- Rekrytering
- Smilow Cancer Hospital-Derby Care Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 203-785-5702
- E-post: canceranswers@yale.edu
-
Huvudutredare:
- Raghav Sundar
-
Fairfield, Connecticut, Förenta staterna, 06824
- Rekrytering
- Smilow Cancer Hospital Care Center-Fairfield
-
Kontakt:
- Site Public Contact
- Telefonnummer: 203-785-5702
- E-post: canceranswers@yale.edu
-
Huvudutredare:
- Raghav Sundar
-
Greenwich, Connecticut, Förenta staterna, 06830
- Rekrytering
- Smilow Cancer Hospital Care Center at Greenwich
-
Kontakt:
- Site Public Contact
- Telefonnummer: 203-785-5702
- E-post: canceranswers@yale.edu
-
Huvudutredare:
- Raghav Sundar
-
Guilford, Connecticut, Förenta staterna, 06437
- Rekrytering
- Smilow Cancer Hospital Care Center - Guilford
-
Kontakt:
- Site Public Contact
- Telefonnummer: 203-785-5702
- E-post: canceranswers@yale.edu
-
Huvudutredare:
- Raghav Sundar
-
New Haven, Connecticut, Förenta staterna, 06520
- Rekrytering
- Yale University
-
Kontakt:
- Site Public Contact
- Telefonnummer: 203-785-5702
- E-post: canceranswers@yale.edu
-
Huvudutredare:
- Raghav Sundar
-
North Haven, Connecticut, Förenta staterna, 06473
- Rekrytering
- Yale-New Haven Hospital North Haven Medical Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 203-785-5702
- E-post: canceranswers@yale.edu
-
Huvudutredare:
- Raghav Sundar
-
Stamford, Connecticut, Förenta staterna, 06902
- Rekrytering
- Smilow Cancer Hospital Care Center at Long Ridge
-
Kontakt:
- Site Public Contact
- Telefonnummer: 203-785-5702
- E-post: canceranswers@yale.edu
-
Huvudutredare:
- Raghav Sundar
-
Torrington, Connecticut, Förenta staterna, 06790
- Rekrytering
- Smilow Cancer Hospital-Torrington Care Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 203-785-5702
- E-post: canceranswers@yale.edu
-
Huvudutredare:
- Raghav Sundar
-
Trumbull, Connecticut, Förenta staterna, 06611
- Rekrytering
- Smilow Cancer Hospital Care Center-Trumbull
-
Kontakt:
- Site Public Contact
- Telefonnummer: 203-785-5702
- E-post: canceranswers@yale.edu
-
Huvudutredare:
- Raghav Sundar
-
Waterbury, Connecticut, Förenta staterna, 06708
- Rekrytering
- Smilow Cancer Hospital-Waterbury Care Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 203-785-5702
- E-post: canceranswers@yale.edu
-
Huvudutredare:
- Raghav Sundar
-
Waterford, Connecticut, Förenta staterna, 06385
- Rekrytering
- Smilow Cancer Hospital Care Center - Waterford
-
Kontakt:
- Site Public Contact
- Telefonnummer: 203-785-5702
- E-post: canceranswers@yale.edu
-
Huvudutredare:
- Raghav Sundar
-
-
Florida
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Gainesville, Florida, Förenta staterna, 32610
- Rekrytering
- UF Health Cancer Institute - Gainesville
-
Kontakt:
- Site Public Contact
- Telefonnummer: 352-273-8010
-
Huvudutredare:
- Lakshmi Balasubramanian
-
-
Georgia
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Atlanta, Georgia, Förenta staterna, 30322
- Rekrytering
- Emory University Hospital/Winship Cancer Institute
-
Kontakt:
- Site Public Contact
- Telefonnummer: 404-778-1868
-
Huvudutredare:
- Seth Concors
-
Atlanta, Georgia, Förenta staterna, 30308
- Rekrytering
- Emory University Hospital Midtown
-
Kontakt:
- Site Public Contact
- Telefonnummer: 888-946-7447
-
Huvudutredare:
- Seth Concors
-
Atlanta, Georgia, Förenta staterna, 30342
- Rekrytering
- Emory Saint Joseph's Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 404-851-7115
-
Huvudutredare:
- Seth Concors
-
-
Illinois
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Chicago, Illinois, Förenta staterna, 60637
- Rekrytering
- University of Chicago Comprehensive Cancer Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 773-702-8222
- E-post: cancerclinicaltrials@bsd.uchicago.edu
-
Huvudutredare:
- Mecker G. Moller
-
Chicago, Illinois, Förenta staterna, 60611
- Rekrytering
- Northwestern University
-
Kontakt:
- Site Public Contact
- Telefonnummer: 312-695-1301
- E-post: cancer@northwestern.edu
-
Huvudutredare:
- Brett L. Ecker
-
Chicago, Illinois, Förenta staterna, 60641
- Rekrytering
- Northwestern Medicine Cancer Center Old Irving Park
-
Kontakt:
- Site Public Contact
- E-post: nctnprogram_rhlccc@northwestern.edu
-
Huvudutredare:
- Brett L. Ecker
-
DeKalb, Illinois, Förenta staterna, 60115
- Rekrytering
- Northwestern Medicine Cancer Center Kishwaukee
-
Kontakt:
- Site Public Contact
- Telefonnummer: 630-352-5360
- E-post: Donald.Smith3@nm.org
-
Huvudutredare:
- Brett L. Ecker
-
Geneva, Illinois, Förenta staterna, 60134
- Rekrytering
- Northwestern Medicine Cancer Center Delnor
-
Kontakt:
- Site Public Contact
- Telefonnummer: 630-352-5360
- E-post: Donald.Smith3@nm.org
-
Huvudutredare:
- Brett L. Ecker
-
Oak Brook, Illinois, Förenta staterna, 60523
- Rekrytering
- Northwestern Medicine Oak Brook
-
Kontakt:
- Site Public Contact
- E-post: nctnprogram_rhlccc@northwestern.edu
-
Huvudutredare:
- Brett L. Ecker
-
Shiloh, Illinois, Förenta staterna, 62269
- Rekrytering
- Memorial Hospital East
-
Kontakt:
- Site Public Contact
- Telefonnummer: 314-747-9912
- E-post: dschwab@wustl.edu
-
Huvudutredare:
- Ramon Jin
-
Warrenville, Illinois, Förenta staterna, 60555
- Rekrytering
- Northwestern Medicine Cancer Center Warrenville
-
Kontakt:
- Site Public Contact
- Telefonnummer: 630-352-5360
- E-post: Donald.Smith3@nm.org
-
Huvudutredare:
- Brett L. Ecker
-
-
Kentucky
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Lexington, Kentucky, Förenta staterna, 40536
- Rekrytering
- University of Kentucky/Markey Cancer Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 859-257-3379
-
Huvudutredare:
- Prakash K. Pandalai
-
-
Louisiana
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New Orleans, Louisiana, Förenta staterna, 70112
- Rekrytering
- University Medical Center New Orleans
-
Kontakt:
- Site Public Contact
- Telefonnummer: 504-210-3539
- E-post: emede1@lsuhsc.edu
-
Huvudutredare:
- Kevin M. Sullivan
-
-
Maryland
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Baltimore, Maryland, Förenta staterna, 21201
- Rekrytering
- University of Maryland/Greenebaum Cancer Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 800-888-8823
-
Huvudutredare:
- Jeremy L. Davis
-
-
Michigan
-
Ann Arbor, Michigan, Förenta staterna, 48109
- Rekrytering
- University of Michigan Rogel Cancer Center
-
Huvudutredare:
- Thomas Enzler
-
Kontakt:
- Site Public Contact
- Telefonnummer: 800-865-1125
- E-post: CancerAnswerLine@med.umich.edu
-
Detroit, Michigan, Förenta staterna, 48202
- Rekrytering
- Henry Ford Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 313-916-3721
- E-post: CTOResearch@hfhs.org
-
Huvudutredare:
- Rupen Shah
-
Grand Rapids, Michigan, Förenta staterna, 49503
- Rekrytering
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 616-391-1230
- E-post: crcwm-regulatory@crcwm.org
-
Huvudutredare:
- Kathleen Y. Butler
-
Kalamazoo, Michigan, Förenta staterna, 49007
- Rekrytering
- West Michigan Cancer Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 616-391-1230
- E-post: crcwm-regulatory@crcwm.org
-
Huvudutredare:
- Kathleen Y. Butler
-
-
Minnesota
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Rochester, Minnesota, Förenta staterna, 55905
- Rekrytering
- Mayo Clinic in Rochester
-
Kontakt:
- Site Public Contact
- Telefonnummer: 855-776-0015
-
Huvudutredare:
- Travis E. Grotz
-
-
Missouri
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City of Saint Peters, Missouri, Förenta staterna, 63376
- Rekrytering
- Siteman Cancer Center at Saint Peters Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 800-600-3606
- E-post: info@siteman.wustl.edu
-
Huvudutredare:
- Ramon Jin
-
Creve Coeur, Missouri, Förenta staterna, 63141
- Rekrytering
- Siteman Cancer Center at West County Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 800-600-3606
- E-post: info@siteman.wustl.edu
-
Huvudutredare:
- Ramon Jin
-
St Louis, Missouri, Förenta staterna, 63110
- Rekrytering
- Washington University School of Medicine
-
Kontakt:
- Site Public Contact
- Telefonnummer: 800-600-3606
- E-post: info@siteman.wustl.edu
-
Huvudutredare:
- Ramon Jin
-
St Louis, Missouri, Förenta staterna, 63129
- Rekrytering
- Siteman Cancer Center-South County
-
Kontakt:
- Site Public Contact
- Telefonnummer: 800-600-3606
- E-post: info@siteman.wustl.edu
-
Huvudutredare:
- Ramon Jin
-
St Louis, Missouri, Förenta staterna, 63136
- Rekrytering
- Siteman Cancer Center at Christian Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 800-600-3606
- E-post: info@siteman.wustl.edu
-
Huvudutredare:
- Ramon Jin
-
-
New Jersey
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Basking Ridge, New Jersey, Förenta staterna, 07920
- Rekrytering
- Memorial Sloan Kettering Basking Ridge
-
Kontakt:
- Site Public Contact
- Telefonnummer: 212-639-7592
-
Huvudutredare:
- George Z. Li
-
Middletown, New Jersey, Förenta staterna, 07748
- Rekrytering
- Memorial Sloan Kettering Monmouth
-
Kontakt:
- Site Public Contact
- Telefonnummer: 212-639-7592
-
Huvudutredare:
- George Z. Li
-
Montvale, New Jersey, Förenta staterna, 07645
- Rekrytering
- Memorial Sloan Kettering Bergen
-
Kontakt:
- Site Public Contact
- Telefonnummer: 212-639-7592
-
Huvudutredare:
- George Z. Li
-
New Brunswick, New Jersey, Förenta staterna, 08903
- Rekrytering
- Rutgers Cancer Institute of New Jersey
-
Kontakt:
- Site Public Contact
- Telefonnummer: 732-235-7356
-
Huvudutredare:
- Haejin In
-
-
New Mexico
-
Albuquerque, New Mexico, Förenta staterna, 87106
- Rekrytering
- University of New Mexico Cancer Center
-
Huvudutredare:
- Alissa Greenbaum
-
Kontakt:
- Site Public Contact
- Telefonnummer: 505-925-0348
- E-post: HSC-ClinicalTrialInfo@salud.unm.edu
-
-
New York
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Commack, New York, Förenta staterna, 11725
- Rekrytering
- Memorial Sloan Kettering Commack
-
Kontakt:
- Site Public Contact
- Telefonnummer: 212-639-7592
-
Huvudutredare:
- George Z. Li
-
East White Plains, New York, Förenta staterna, 10604
- Rekrytering
- Memorial Sloan Kettering Westchester
-
Kontakt:
- Site Public Contact
- Telefonnummer: 212-639-7592
-
Huvudutredare:
- George Z. Li
-
Mineola, New York, Förenta staterna, 11501
- Rekrytering
- NYU Langone Hospital - Long Island
-
Kontakt:
- Site Public Contact
- Telefonnummer: 212-263-4432
- E-post: cancertrials@nyulangone.org
-
Huvudutredare:
- Zachary J. Brown
-
New York, New York, Förenta staterna, 10065
- Rekrytering
- Memorial Sloan Kettering Cancer Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 212-639-7592
-
Huvudutredare:
- George Z. Li
-
New York, New York, Förenta staterna, 10016
- Rekrytering
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
-
Kontakt:
- Site Public Contact
- E-post: CancerTrials@nyulangone.org
-
Huvudutredare:
- Zachary J. Brown
-
Uniondale, New York, Förenta staterna, 11553
- Rekrytering
- Memorial Sloan Kettering Nassau
-
Kontakt:
- Site Public Contact
- Telefonnummer: 212-639-7592
-
Huvudutredare:
- George Z. Li
-
-
North Carolina
-
Chapel Hill, North Carolina, Förenta staterna, 27599
- Rekrytering
- UNC Lineberger Comprehensive Cancer Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 877-668-0683
- E-post: cancerclinicaltrials@med.unc.edu
-
Huvudutredare:
- Ashwin Somasundaram
-
Hillsborough, North Carolina, Förenta staterna, 27278
- Rekrytering
- University of North Carolina-Hillsborough Campus
-
Kontakt:
- Site Public Contact
- Telefonnummer: 877-668-0683
- E-post: cancerclinicaltrials@med.unc.edu
-
Huvudutredare:
- Ashwin Somasundaram
-
Winston-Salem, North Carolina, Förenta staterna, 27157
- Rekrytering
- Wake Forest University Health Sciences
-
Huvudutredare:
- Edward A. Levine
-
Kontakt:
- Site Public Contact
- Telefonnummer: 336-713-6771
-
-
North Dakota
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Fargo, North Dakota, Förenta staterna, 58122
- Rekrytering
- Sanford Roger Maris Cancer Center
-
Huvudutredare:
- Daniel Almquist
-
Kontakt:
- Site Public Contact
- Telefonnummer: 701-234-6161
- E-post: OncologyClinicalTrialsFargo@sanfordhealth.org
-
-
Ohio
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Columbus, Ohio, Förenta staterna, 43210
- Rekrytering
- Ohio State University Comprehensive Cancer Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 800-293-5066
- E-post: Jamesline@osumc.edu
-
Huvudutredare:
- Pamela W. Lu
-
-
Oregon
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Portland, Oregon, Förenta staterna, 97239
- Rekrytering
- Oregon Health and Science University
-
Kontakt:
- Site Public Contact
- Telefonnummer: 503-494-1080
- E-post: trials@ohsu.edu
-
Huvudutredare:
- Divya Sood
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Förenta staterna, 19107
- Rekrytering
- Thomas Jefferson University Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 215-600-9151
- E-post: ONCTrialNow@jefferson.edu
-
Huvudutredare:
- Nader Hanna
-
Pittsburgh, Pennsylvania, Förenta staterna, 15237
- Rekrytering
- UPMC-Passavant Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 412-367-6454
-
Huvudutredare:
- Mohammad Haroon A. Choudry
-
Pittsburgh, Pennsylvania, Förenta staterna, 15232
- Rekrytering
- UPMC Hillman Cancer Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 412-647-8073
-
Huvudutredare:
- Mohammad Haroon A. Choudry
-
-
Rhode Island
-
Westerly, Rhode Island, Förenta staterna, 02891
- Rekrytering
- Smilow Cancer Hospital Care Center - Westerly
-
Kontakt:
- Site Public Contact
- Telefonnummer: 203-785-5702
- E-post: canceranswers@yale.edu
-
Huvudutredare:
- Raghav Sundar
-
-
Tennessee
-
Nashville, Tennessee, Förenta staterna, 37232
- Rekrytering
- Vanderbilt University/Ingram Cancer Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 800-811-8480
-
Huvudutredare:
- Deepa Magge
-
-
Texas
-
Dallas, Texas, Förenta staterna, 75390
- Rekrytering
- UT Southwestern/Simmons Cancer Center-Dallas
-
Kontakt:
- Site Public Contact
- Telefonnummer: 214-648-7097
- E-post: canceranswerline@UTSouthwestern.edu
-
Huvudutredare:
- Alex C. Kim
-
Dallas, Texas, Förenta staterna, 75235
- Rekrytering
- Parkland Memorial Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 214-590-5582
- E-post: canceranswerline@UTSouthwestern.edu
-
Huvudutredare:
- Alex C. Kim
-
Dallas, Texas, Förenta staterna, 75237
- Rekrytering
- UT Southwestern Simmons Cancer Center - RedBird
-
Huvudutredare:
- Alex C. Kim
-
Kontakt:
- Site Public Contact
- Telefonnummer: 214-648-7097
- E-post: canceranswerline@utsouthwestern.edu
-
Fort Worth, Texas, Förenta staterna, 76104
- Rekrytering
- UT Southwestern/Simmons Cancer Center-Fort Worth
-
Kontakt:
- Site Public Contact
- Telefonnummer: 214-648-7097
- E-post: canceranswerline@UTSouthwestern.edu
-
Huvudutredare:
- Alex C. Kim
-
Richardson, Texas, Förenta staterna, 75080
- Rekrytering
- UT Southwestern Clinical Center at Richardson/Plano
-
Kontakt:
- Site Public Contact
- Telefonnummer: 972-669-7044
- E-post: Suzanne.cole@utsouthwestern.edu
-
Huvudutredare:
- Alex C. Kim
-
-
Utah
-
Salt Lake City, Utah, Förenta staterna, 84112
- Rekrytering
- Huntsman Cancer Institute/University of Utah
-
Kontakt:
- Site Public Contact
- Telefonnummer: 888-424-2100
- E-post: cancerinfo@hci.utah.edu
-
Huvudutredare:
- Erin P. Ward
-
-
Wisconsin
-
Madison, Wisconsin, Förenta staterna, 53792
- Rekrytering
- University of Wisconsin Carbone Cancer Center - University Hospital
-
Huvudutredare:
- Nataliya V. Uboha
-
Kontakt:
- Site Public Contact
- Telefonnummer: 800-622-8922
- E-post: clinicaltrials@cancer.wisc.edu
-
Madison, Wisconsin, Förenta staterna, 53718
- Rekrytering
- University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
-
Huvudutredare:
- Nataliya V. Uboha
-
Kontakt:
- Site Public Contact
- Telefonnummer: 800-622-8922
- E-post: clinicaltrials@cancer.wisc.edu
-
Marshfield, Wisconsin, Förenta staterna, 54449
- Rekrytering
- Marshfield Medical Center-Marshfield
-
Kontakt:
- Site Public Contact
- Telefonnummer: 800-782-8581
- E-post: oncology.clinical.trials@marshfieldresearch.org
-
Huvudutredare:
- Rohit Sharma
-
Menomonee Falls, Wisconsin, Förenta staterna, 53051
- Rekrytering
- Froedtert Menomonee Falls Hospital
-
Kontakt:
- Site Public Contact
- Telefonnummer: 262-257-5100
-
Huvudutredare:
- Ugwuji N. Maduekwe
-
Milwaukee, Wisconsin, Förenta staterna, 53226
- Rekrytering
- Medical College of Wisconsin
-
Kontakt:
- Site Public Contact
- Telefonnummer: 414-805-3666
-
Huvudutredare:
- Ugwuji N. Maduekwe
-
New Berlin, Wisconsin, Förenta staterna, 53151
- Rekrytering
- Froedtert and MCW Moorland Reserve Health Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 414-805-0505
-
Huvudutredare:
- Ugwuji N. Maduekwe
-
Oak Creek, Wisconsin, Förenta staterna, 53154
- Rekrytering
- Drexel Town Square Health Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 414-805-0505
-
Huvudutredare:
- Ugwuji N. Maduekwe
-
West Bend, Wisconsin, Förenta staterna, 53095
- Rekrytering
- Froedtert West Bend Hospital/Kraemer Cancer Center
-
Kontakt:
- Site Public Contact
- Telefonnummer: 414-805-0505
-
Huvudutredare:
- Ugwuji N. Maduekwe
-
Weston, Wisconsin, Förenta staterna, 54476
- Rekrytering
- Marshfield Medical Center - Weston
-
Kontakt:
- Site Public Contact
- Telefonnummer: 800-782-8581
- E-post: oncology.clinical.trials@marshfieldresearch.org
-
Huvudutredare:
- Rohit Sharma
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Step 1, Arm A (standard systemic therapy)
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. |
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.
Andra namn:
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.
Andra namn:
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.
Andra namn:
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. 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.
Andra namn:
|
|
Experimentell: Step 1, Arm B (Systemic Therapy + Intraperitoneal Paclitaxel)
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. |
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.
Andra namn:
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.
Andra namn:
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.
Andra namn:
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. 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.
Andra namn:
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. 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Progression free survival (Phase II)
Tidsram: From randomization to progression or death without documentation of progression, assessed up to 5 years.
|
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). |
From randomization to progression or death without documentation of progression, assessed up to 5 years.
|
|
Overall survival (Phase III)
Tidsram: From randomization to the date of death, of any cause, assessed up to 5 years
|
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. |
From randomization to the date of death, of any cause, assessed up to 5 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of adverse events
Tidsram: Up to 30 days after the last day of protocol treatment
|
Safety and tolerability will be assessed by counting treatment-related grade 3 or higher toxicity events of the patients. |
Up to 30 days after the last day of protocol treatment
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Maheswari Senthil, ECOG-ACRIN Cancer Research Group
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter plats
- Neoplasmer
- Neoplasmer i matsmältningssystemet
- Matsmältningssystemets sjukdomar
- Peritoneala sjukdomar
- Neoplasmer i buken
- Peritoneala neoplasmer
- Administration
- Sjukvårdskvalitet, tillgång och utvärdering
- Undersökningstekniker
- Kliniska laboratorietekniker
- Diagnostiska tekniker och procedurer
- Diagnos
- Kirurgiska ingrepp, operativ
- Minimalt invasiva kirurgiska ingrepp
- Hälsovårdskvalitet
- Kvalitetsindikatorer, hälsovård
- Diagnostiska tekniker, kirurgiska
- Endoskopi
- Kemitekniker, analytiska
- Spektrumanalys
- Riktlinjer som ämne
- Kvalitetssäkring, hälsovård
- Vårdstandard
- Provhantering
- Magnetresonansspektroskopi
- Öva riktlinjer som ämne
- Laparoskopi
Andra studie-ID-nummer
- EA2234
- U10CA180820 (U.S.S. NIH-anslag/kontrakt)
- EA2234 (Annan identifierare: CTEP)
- NCI-2025-01831 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
- EA2234 (Annan identifierare: ECOG-ACRIN Cancer Research Group)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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