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New treatment option for Gastric Adenocarcinoma
Official title Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for Treatment of Gastric Cancer With Limited Peritoneal Metastasis, ROBO-CHIP Study
ClinicalTrials.gov ID: NCT05753306
What this study is testing
What is Cisplatin?
Cisplatin is an investigational medicine, being studied as a potential treatment for gastric adenocarcinoma.
Also referred to as Abiplatin, Blastolem.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II clinical trial tests how well robotic cytoreduction and hyperthermic intraperitoneal chemotherapy (HIPEC) in treating patients with gastric cancer that has spread to the tissue that lines the wall of the abdominal cavity (peritoneum). Gastric cancer is the third leading cause of cancer related deaths worldwide and peritoneal metastasis are found in 30% of patients at time of diagnosis.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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
You likely can't join if
- 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
- people deemed unable to comply with study and/or follow-up procedures
- people with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of...
See the full eligibility 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
- 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
- people deemed unable to comply with study and/or follow-up procedures
- people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.