Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-26 @ 1:16 PM
NCT ID:
NCT05753306
Eligibility Criteria:
Inclusion Criteria:
* Restricted to 18 to 80 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* Histologic confirmation of gastric adenocarcinoma including all subtypes and Siewert type II/III gastroesophageal (GE) junction adenocarcinomas
* Absolute neutrophil count \>= 1,500 / uL
* Platelets \>= 50,000 / Ul
* Serum creatinine \<= 1.5 mg / dL
* Adequate nutritional status (Albumin \>= 3.5)
* Metastasis confined to the peritoneum:
* Positive peritoneal cytology
* Peritoneal metastasis on diagnostic laparoscopy
* Peritoneal metastasis on imaging
* Response to systemic chemotherapy defined as at least one of the following:
* Reduction (\>= 30%) in standardized uptake value (SUV) max \[Response Evaluation Criteria in Solid Tumors (RECIST) criteria\]
* Reduction in size of primary tumor, regional lymph node or peritoneal metastasis on imaging (\>= 20% decrease in the longest diameter of target lesion) RECIST criteria
* Reduction ( \>= 30%) in Peritoneal Carcinomatosis Index (PCI) or conversion of peritoneal cytology
* Reduction ( \>= 30%) in serum tumor markers CEA or CA 19-9
* Peritoneal Carcinomatosis Index (PCI) =\< 7 and surgeon deems high likelihood for a complete cytoreduction
* Body Mass Index (BMI) =\< 35 kg/m\^2
Exclusion Criteria:
* Distant metastatic disease not limited to peritoneum, such as solid organ metastases (liver, lung, bone, distant lymph node, etc)
* Malignant ascites at time of study enrollment
* Comorbidities that would preclude protocol therapy
* Subjects deemed unable to comply with study and/or follow-up procedures
* Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05753306
Study Brief:
Protocol Section:
NCT05753306