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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

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

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 more

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

~1940

Hyperthermic Intraperitoneal Chemotherapy

2010

Completed Phase 3

~210

Biospecimen Collection

2004

Completed Phase 2

~1700

Positron Emission Tomography

2008

Completed Phase 2

~2240

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

~1190

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,216 Previous Clinical Trials

3,767,468 Total Patients Enrolled

Travis E GrotzPrincipal InvestigatorMayo Clinic in Rochester

2 Previous Clinical Trials

55 Total Patients Enrolled

Media Library

Cisplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05753306 — Phase 2

Stomach Cancer Research Study Groups: Treatment (gastrectomy, HIPEC)

Stomach Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT05753306 — Phase 2

Cisplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05753306 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor accepting individuals beyond the age of 30?

"This medical trial is open to any individual aged 18 or older and below the age of 80."

Answered by AI

To whom does this medical experiment extend its invitation?

"To be eligible to participate, applicants must have a diagnosis of stomach cancer and fall within the age bracket of 18-80 years old. The trial is hoping to recruit 20 participants in total."

Answered by AI

What is the primary objective of this investigation?

"This experiment's key metric is the 30 day readmission rate over an approximate one year period. To complement this goal, two other measurements shall be assessed; Peritoneal recurrence free survival (via descriptive statistics and Kaplan-Meier estimation) and Open conversion rate (using descriptive stats). Lastly, a measure of Overall Survival will also be used to determine differences between groups through log-rank testing."

Answered by AI

What potential risks are associated with the gastrectomy and HIPEC treatments?

"The safety of this treatment (gastrectomy, HIPEC) was scored a 2 on our risk assessment scale since there is evidence for its security but no data confirming efficacy."

Answered by AI

Is there still room to join this research initiative?

"Confirmed. This clinical trial, which was originally advertised on February 28th 2023 and had its most recent update two days later, is no longer seeking patients. However, there are 3125 other medical studies actively enrolling individuals at the present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for Treatment of Gastric Cancer With Limited Peritoneal Metastasis, ROBO-CHIP Study

2023. "Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for Treatment of Gastric Cancer With Limited Peritoneal Metastasis, ROBO-CHIP Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05753306.

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