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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMayo Clinic

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Cisplatin

    Drug

    Given via HIPEC

  • Computed Tomography

    Procedure/Surgery

    Undergo CT scan or PET/CT

  • Gastrectomy

    Procedure/Surgery

    Undergo robotic gastrectomy

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PE/CT

  • Questionnaire Administration

    Other intervention

    Complete questionnaire

  • Paclitaxel

    Drug

    Given via HIPEC

  • Hyperthermic Intraperitoneal Chemotherapy

    Drug

    Undergo HIPEC

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Treatment (gastrectomy, HIPEC)Experimental treatment 8 interventions

Trial outcomes

Primary outcomes

1

Hospital length of stay

Recorded as number of days in hospital following surgery.

Time frame
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

Time frame
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)

Time frame
Up to 30 days post surgery

Secondary outcomes

1

Operative time

Recorded as the time from incision to close

Time frame
Intraoperative
2

Opioid consumption

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

Time frame
Up to 3 years
3

Nursing reported pain scores

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

Time frame
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.

Time frame
Up to 3 years

Other outcomes

Sponsors and contacts

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