Actively Recruiting
Testing the Addition of Paclitaxel Administered Into the Abdominal Cavity Combined With Chemotherapy for Patients With Gastric Cancer Spread to the Abdominal Cavity
Led by ECOG-ACRIN Cancer Research Group · Updated on 2026-05-05
148
Participants Needed
10
Research Sites
249 weeks
Total Duration
On this page
Sponsors
E
ECOG-ACRIN Cancer Research Group
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Testing the Addition of Paclitaxel Administered Into the Abdominal Cavity Combined With Chemotherapy for Patients With Gastric Cancer Spread to the Abdominal Cavity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Histologically or cytologically confirmed microsatellite stable or mismatch repair proficient primary gastric or gastroesophageal junction adenocarcinoma with synchronous cytology positive disease or peritoneal carcinomatosis
- Received 3 to 6 months of first-line systemic treatment
- Registered within 4 weeks of last dose of first-line therapy
- No ongoing significant adverse events preventing diagnostic laparoscopy
- No small or large bowel obstruction except gastric outlet obstruction due to cancer
- No solid organ metastases except ovarian metastases
- No significant radiologic peritoneal disease progression during first-line therapy
- No extensive unresectable retroperitoneal lymph node metastases
- No prior surgery preventing safe laparoscopy and port placement
- No massive ascites or history of frequent large volume paracentesis
- Cardiac function New York Heart Association Class II or better if history of cardiac disease
- No uncontrolled illness or significant conditions making protocol hazardous
- No known allergies or contraindications to paclitaxel, 5-fluorouracil, or leucovorin
- Leukocytes ≥ 2,000/uL, ANC ≥ 1,500/uL, Platelets ≥ 75,000/uL within 30 days prior to registration
- Total bilirubin ≤ 1.5 times institutional upper limit of normal (≤ 2.0 mg/dL if Gilbert's syndrome)
- AST and ALT ≤ 3.0 times institutional upper limit of normal within 30 days prior to registration
- Creatinine clearance ≥ 30 mL/min within 30 days prior to registration
- Hemoglobin ≥ 8 g/dL and serum albumin ≥ 2.5 g/dL within 30 days prior to registration
- HIV-infected patients on effective therapy with undetectable viral load within 6 months
- Hepatitis B patients with undetectable viral load on suppressive therapy
- Hepatitis C patients treated and cured or with undetectable viral load if on treatment
- Prior or concurrent malignancy not interfering with safety or efficacy assessment
- Not pregnant or breastfeeding; women of childbearing potential must have negative pregnancy test within 14 days prior to registration
- Agree to use effective contraception or abstain from sexual intercourse during the study and as required after treatment
- Ability and willingness to sign informed consent or have legally authorized representative if impaired
You will not qualify if you...
- Microsatellite instability-high (MSI-H) or mismatch repair deficient disease
- Extensive intraabdominal adhesions preventing safe intraperitoneal port placement
- Evidence of massive ascites or frequent large volume paracentesis within 30 days prior to registration
- Evidence of extensive unresectable retroperitoneal lymph node metastases
- Small or large bowel obstruction other than gastric outlet obstruction due to cancer
- Ongoing significant adverse events that prohibit diagnostic laparoscopy
- Known contraindications or allergies to protocol treatment agents paclitaxel, 5-fluorouracil, or leucovorin
- Uncontrolled intercurrent illness or other significant conditions making protocol hazardous
- Pregnant or breastfeeding women
- Patients with prior surgery precluding safe diagnostic laparoscopy and port placement
- Evidence of clinically significant radiologic peritoneal disease progression during first-line therapy
- Cardiac function worse than New York Heart Association Class II in patients with cardiac disease history
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
UC Irvine Health/Chao Family Comprehensive Cancer Center
Irvine, California, United States, 92612
Actively Recruiting
2
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Orange, California, United States, 92868
Actively Recruiting
3
Schulze Family Foundation Cancer Clinic - Bonita Health Center
Bonita Springs, Florida, United States, 34135
Not Yet Recruiting
4
Lee Memorial Health System
Fort Myers, Florida, United States, 33901
Not Yet Recruiting
5
Regional Cancer Center-Lee Memorial Health System
Fort Myers, Florida, United States, 33905
Not Yet Recruiting
6
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
7
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Not Yet Recruiting
8
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, United States, 15237
Not Yet Recruiting
9
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, United States, 53718
Not Yet Recruiting
10
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States, 53792
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here