Phase II Study of Paclitaxel Treatment and Gastrectomy Surgery for Adults with Gastric Adenocarcinoma and Peritoneal Carcinomatosis or Positive Cytology

What this Trial Is About

Researchers are studying the effects of paclitaxel combined with gastrectomy surgery to remove all or part of the stomach on patients diagnosed with stage IV gastric or gastroesophageal cancer who have positive cytology or carcinomatosis. The main goal is to assess overall survival from diagnosis and to evaluate the safety of gastrectomy after perioperative intraperitoneal paclitaxel treatment. This is a Phase II clinical trial sponsored by M.D. Anderson Cancer Center. Participants receive paclitaxel by intraperitoneal injection every two weeks for six weeks. Depending on the doctors recommendation, participants may then undergo gastrectomy surgery. After surgery, additional paclitaxel treatment is given every two weeks for another six weeks. Other supportive medications such as dexamethasone, diphenhydramine, and famotidine are also administered intravenously as part of the treatment regimen. During the study, participants will be monitored for adverse events using standard criteria throughout the average one-year follow-up period. Assessments will include evaluations of overall survival and treatment safety. The study involves regular visits for treatment administration, safety monitoring, and follow-up evaluations. Participation duration varies but involves perioperative treatment and monitoring over approximately one year.

A Phase II Study of Perioperative Paclitaxel in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology