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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-00431 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 22-004680 | Other Identifier | Mayo Clinic in Rochester |
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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. Patients with peritoneal metastasis have poor survival rates. Traditional surgery is done with a large incision and has a high complication rate and longer hospital stays. Robot assisted (robotic) cytoreduction is a surgical option that uses small incisions and there is less risk of complications. HIPEC involves infusing heated chemotherapy into the abdominal cavity during surgery. Robotic cytoreduction together with HIPEC may improve recovery and decrease complications after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (gastrectomy, HIPEC) | Experimental | Patients undergo collection of stool and blood sample before and after surgery. Patients also undergo robotic gastrectomy and HIPEC with docetaxel and cisplatin on study. Patients undergo CT, MRI, or PET/CT scans throughout the trial. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin | Drug | Given via HIPEC |
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| Measure | Description | Time Frame |
|---|---|---|
| Hospital length of stay | Recorded as number of days in hospital following surgery. | Up to 30 days post-surgery |
| 30 day readmission rate | Assessed by the number of participants who are re-admitted to the hospital after being discharged post-surgery | Up to 30 days post-surgery |
| Adverse Events | Assessed by Clavien-Dindo Classification (grade 1-5, grade 1 being least severe and grade 5 being death) | Up to 30 days post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Recorded as the time from incision to close | Intraoperative |
| Opioid consumption | Assessed by morphine milligram equivalents during hospitalization and post-surgical recovery. |
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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:
Response to systemic chemotherapy defined as at least one of the following:
Peritoneal Carcinomatosis Index (PCI) =< 7 and surgeon deems high likelihood for a complete cytoreduction
Body Mass Index (BMI) =< 35 kg/m^2
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Travis E Grotz, MD | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 9, 2025 | Feb 23, 2026 |
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| Computed Tomography | Procedure | Undergo CT scan or PET/CT |
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| Gastrectomy | Procedure | Undergo robotic gastrectomy |
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| Magnetic Resonance Imaging | Procedure | Undergo MRI |
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| Positron Emission Tomography | Procedure | Undergo PE/CT |
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| Questionnaire Administration | Other | Complete questionnaire |
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| Paclitaxel | Drug | Given via HIPEC |
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| Hyperthermic Intraperitoneal Chemotherapy | Drug | Undergo HIPEC |
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| Up to 3 years |
| Nursing reported pain scores | As recorded (mean and max) during hospitalization and post-surgery follow-up visits | Up to 3 years |
| Recurrence-Free Survival (RFS) | Assessed from the date of gastrectomy and hyperthermic intraperitoneal chemotherapy (HIPEC). Patterns of tumor recurrence will be assessed by reviewing routine surveillance imaging. | Up to 3 years |
| Overall Survival (OS) | Defined as the time from gastrectomy and HIPEC until death due to any cause. | Up to 3 years |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D002945 | Cisplatin |
| C044245 | 1,2-diaminocyclohexaneplatinum II citrate |
| D010984 | Platinum |
| D005743 | Gastrectomy |
| D009682 | Magnetic Resonance Spectroscopy |
| D017239 | Paclitaxel |
| C080625 | taxane |
| D013660 | Taxes |
| D000068196 | Albumin-Bound Paclitaxel |
| D000084262 | Hyperthermic Intraperitoneal Chemotherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D028561 | Transition Elements |
| D008670 | Metals |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D017024 | Chemotherapy, Adjuvant |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D006979 | Hyperthermia, Induced |
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