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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

No Placebo-Only Group

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

30 day Clavien-Dindo grade III complications

30 day readmission rate

Hospital length of stay

Secondary study objectives

Disease-free survival

Estimated blood loss

Nursing reported pain scores

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

Cisplatin

2013

Completed Phase 3

~3120

Hyperthermic Intraperitoneal Chemotherapy

2010

Completed Phase 3

~210