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Gastric AdenocarcinomaPhase 2NCT05753306

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

A Phase 2 study testing Cisplatin, Computed Tomography and Gastrectomy in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Mayo Clinic at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Cisplatin, Computed Tomography and Gastrectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
20 Apr 2023to 25 Mar 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 18Show fewer
  • 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

Who cannot join

  • 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
  • Subjects deemed unable to comply with study and/or follow-up procedures
  • Subjects 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 or incapacity

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Referral Office contact

855-776-0015

mayocliniccancerstudies@mayo.edu

United States1 site, 1 recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu

    Travis E. Grotz, MD

    Recruiting

Other trials in United States

About this study

Official title: A Phase II Study of Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Gastric Cancer and Limited Peritoneal Metastasis: ROBO-CHIP Trial

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.

Being tested
Cisplatin, Computed Tomography, Gastrectomy, Magnetic Resonance Imaging, Positron Emission Tomography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Given via HIPEC

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT scan or PET/CT

  • GastrectomyProcedure or surgery

    Also called Gastric Resection

    Undergo robotic gastrectomy

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR

    Undergo MRI

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan

    Undergo PE/CT

  • Questionnaire AdministrationOther

    Complete questionnaire

  • PaclitaxelDrug

    Also called Taxane, Taxol, 5beta,20-Epoxy-1,2-alpha,4,7beta,10beta,13alpha-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine, Taxol Konzentrat

    Given via HIPEC

  • Hyperthermic Intraperitoneal ChemotherapyDrug

    Also called HIPEC

    Undergo HIPEC

Study groups in NCT05753306
Study groupRoleWhat they receive
Treatment (gastrectomy, HIPEC)ExperimentalPatients 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.
Receives: Drug: Cisplatin; Procedure: Computed Tomography; Procedure: Gastrectomy; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Drug: Paclitaxel; Drug: Hyperthermic Intraperitoneal Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hospital length of stay

    Recorded as number of days in hospital following surgery.

    Measured: Up to 30 days post-surgery

  2. 30 day readmission rate

    Assessed by the number of participants who are re-admitted to the hospital after being discharged post-surgery

    Measured: Up to 30 days post-surgery

  3. Adverse Events

    Assessed by Clavien-Dindo Classification (grade 1-5, grade 1 being least severe and grade 5 being death)

    Measured: Up to 30 days post surgery

Secondary outcomes (5)

  1. Operative time

    Recorded as the time from incision to close

    Measured: Intraoperative

  2. Opioid consumption

    Assessed by morphine milligram equivalents during hospitalization and post-surgical recovery.

    Measured: Up to 3 years

  3. Nursing reported pain scores

    As recorded (mean and max) during hospitalization and post-surgery follow-up visits

    Measured: Up to 3 years

  4. 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.

    Measured: Up to 3 years

  5. Overall Survival (OS)

    Defined as the time from gastrectomy and HIPEC until death due to any cause.

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2023
  2. Study start20 Apr 2023
  3. Primary completion25 Mar 2030 (estimated)
  4. Study completion25 Mar 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05753306
Sponsor's protocol ID
22-004680
Other IDs
NCI-2023-00431, 22-004680
Status last verified
Apr 2026
First submitted
22 Feb 2023
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cisplatin, Computed Tomography and Gastrectomy in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospital length of stay (time frame: Up to 30 days post-surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05753306.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.

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