Testing Paclitaxel Directly in the Abdomen for Gastric Cancer
This study is investigating if adding paclitaxel chemotherapy directly into your abdominal cavity, along with standard chemotherapy given through a vein, can better treat gastric (stomach) or gastroesophageal junction (where the esophagus meets the stomach) cancer that has spread to the abdomen. The standard chemotherapy options include common regimens like FOLFOX, CAPOX, FLOT, CF, and CX. Researchers want to see if this combination can prevent your cancer from growing or spreading for longer (progression-free survival) and help you live longer overall (overall survival). You may be eligible if you are at least 18 years old, have a good performance status, and your cancer is microsatellite stable (MSS) or has proficient mismatch repair (MMR) protein expression. The study is currently recruiting 148 participants, but its overall status is unclear.
- Study design
- This is an interventional study with an unclear phase, planning to enroll 148 participants. It compares standard chemotherapy alone to standard chemotherapy plus paclitaxel given directly into the abdominal cavity.
- What's involved
- If you join, you will first have a diagnostic laparoscopy (a surgical procedure to look inside your abdomen). You will then be assigned to one of two groups and receive either standard chemotherapy or standard chemotherapy plus paclitaxel, with treatments repeating every 21 days for up to 4 cycles. You will also have blood draws and CT or MRI scans throughout the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progression-free survival and overall survival will be assessed for up to 5 years after randomization.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Testing the Addition of Paclitaxel Administered Into the Abdominal Cavity Combined With Chemotherapy for Patients With Gastric Cancer Spread to the Abdominal Cavity
At a glance
Conditions
Where it's being run
78 sites across 25 statesStudy leadership
- Maheswari Senthil · PRINCIPAL_INVESTIGATOR · ECOG-ACRIN Cancer Research Group
Who to contact
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What this trial measures
- Progression free survival (Phase II)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).
- Overall survival (Phase III)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.