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Chemotherapy
Robotic Surgery + HIPEC for Stomach Cancer
Phase 2
Recruiting
Led By Travis E Grotz
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial tests if robotic cytoreduction & HIPEC can improve survival & reduce complications in gastric cancer patients with peritoneal metastasis.
Who is the study for?
Adults aged 18-80 with gastric cancer that has spread only to the lining of their abdomen, responding well to chemotherapy, and in good nutritional health can join. They must have a certain level of blood cells, kidney function, and body weight. People with cancer outside the abdomen or severe reactions to chemo can't participate.Check my eligibility
What is being tested?
The trial is testing robotic surgery combined with heated chemo delivered directly into the belly (HIPEC) for stomach cancer patients with limited spread. It aims to see if this approach reduces complications compared to traditional open surgery.See study design
What are the potential side effects?
Possible side effects include typical surgical risks like infection and bleeding, as well as those from chemo such as nausea, fatigue, hair loss, nerve damage and increased risk of infections due to lowered immunity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
30 day Clavien-Dindo grade III complications
30 day readmission rate
Hospital length of stay
Secondary outcome measures
Disease-free survival
Estimated blood loss
Nursing reported pain scores
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (gastrectomy, HIPEC)Experimental Treatment9 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hyperthermic Intraperitoneal Chemotherapy
2010
Completed Phase 3
~210
Cisplatin
2013
Completed Phase 3
~1940
Biospecimen Collection
2004
Completed Phase 2
~1720
Positron Emission Tomography
2008
Completed Phase 2
~2210
Computed Tomography
2017
Completed Phase 2
~2720
Docetaxel
1995
Completed Phase 4
~5620
Gastrectomy
2017
Completed Phase 2
~1330
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,251 Previous Clinical Trials
3,785,388 Total Patients Enrolled
Travis E GrotzPrincipal InvestigatorMayo Clinic in Rochester
2 Previous Clinical Trials
55 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself but might not be able to do heavy physical work.My cancer has spread to organs like the liver, lungs, or bones.I've had a severe allergic reaction to chemotherapy before.My cancer is confirmed as gastric adenocarcinoma or GE junction adenocarcinoma.I can follow the study's requirements and attend all follow-ups.I am between 18 and 80 years old.My cancer has spread to the lining of my abdomen.I have fluid buildup in my abdomen due to cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (gastrectomy, HIPEC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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