Randomized Trial Comparing Standard Chemotherapy Alone Versus Chemotherapy with Intraperitoneal Paclitaxel for Advanced Gastric and Gastroesophageal Cancer

What this Trial Is About

Researchers are evaluating whether adding paclitaxel chemotherapy directly into the abdominal cavity, alongside chemotherapy given through a vein, can better control the spread or growth of gastric cancer that has spread to the abdominal cavity. The study compares this combination approach to the usual chemotherapy treatment for this cancer type. The trial includes a surgical procedure called diagnostic laparoscopy to examine the abdomen and determine the appropriate treatment group for each participant. Participants will undergo diagnostic laparoscopy under general anesthesia, during which they will be randomly assigned to one of two groups. One group receives standard chemotherapy through the vein alone, while the other group receives the same chemotherapy plus paclitaxel delivered directly into the abdomen via an intraperitoneal port placed during surgery. Treatment cycles occur every 21 days for four cycles, with assessments after three months to decide whether to continue treatment or consider surgery to remove the cancer if possible. During the study, participants will have regular imaging scans such as CT or MRI to monitor disease status and blood samples collected periodically. After completing treatment, follow-up visits occur every three months for the first two years and then every six months up to five years to watch for side effects and cancer progression. Researchers will measure progression-free survival and overall survival to evaluate the treatments, along with monitoring adverse events related to the therapy.

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