Laparoscopic Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) for Metastatic Gastric Cancer

May 19, 2021 updated by: M.D. Anderson Cancer Center

A Phase II Study of Laparoscopic Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) for Gastric Carcinomatosis or Positive Cytology

The goal of this clinical research study is to learn if hyperthermic intraperitoneal chemotherapy (HIPEC) will help to control the disease in patients with Stage 4 stomach or gastroesophageal cancer. The safety of this treatment will also be studied.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

HIPEC Treatment:

If you are found to be eligible to take part in this study, on the day of HIPEC treatment, you will receive heated mitomycin-C and cisplatin as a liquid that is injected through 3 to 4 small incisions in your abdomen for about 1 hour. This will be done as a surgical procedure, and you will be under general anesthesia. The chemotherapy will then be flushed out of your abdomen and collected, and the treatment area inside your abdomen will be washed. Also during the HIPEC procedure, fluid will be collected and checked for cancer cells. As is standard of care, any lesions that are found during treatment may also be biopsied at this time, if the study doctor thinks it is necessary. You may receive up to 5 HIPEC treatments on this study.

You will also receive sodium thiosulfate by vein over about 20 minutes to protect the kidneys.

You will remain in the hospital for 3-7 days after treatment.

While you are in the hospital after surgery:

  • Blood (about 2-3 tablespoons) may be drawn for routine tests, if the study doctor thinks it is necessary.

Study Visits:

One (1) time between Weeks 2-6:

  • You will have a physical exam.
  • Blood (about 2-3 tablespoons) will be drawn for routine tests.

Gastrectomy Surgery:

If your doctor thinks it is needed, you will have a standard of care surgery. You will receive a separate consent form which explains the surgery and its risks.

On or before 8 weeks after your surgery:

  • You will have a physical exam.
  • Blood (about 2-3 tablespoons) will be drawn for routine tests.

Follow-Up Visits:

You will have routine clinic visits every 6 months from the date of your last surgery. You will be asked about any other cancer treatments you may be receiving. If you stopped the study early, the study doctor may ask you to return to the office for extra CT scans, PET scan, or MRIs during the follow-up period.

You will have a CT scan, PET scan, or MRI of your chest, abdomen, and pelvis every 6 months for 5 years after surgery to check the status of the disease.

Length of Study Participation:

You will be on study for about 5 years after your last surgery. You will be taken off study early if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over after the follow-up visits.

This is an investigational study. The chemotherapy and surgery are standard treatment for stomach and gastroesophageal cancer. It is investigational to give the chemotherapy by HIPEC.

Up to 30 participants will take part in this study. All will be enrolled at MD Anderson.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18 years and above. There will be no upper age restriction.
  2. Eastern Cooperative Oncology Group (ECOG) performance status </= 2.
  3. Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction.
  4. Adequate renal, and bone marrow function: a. Leukocytes >/= 3,000/microL; b. Absolute neutrophil count >/= 1,500/microL; c. Platelets >/= 100,000/Ul; d. Serum creatinine </= 1.5 mg/dL.
  5. Hepatic function: AST (SGOT)/ALT (SGPT) </= 5 X institutional (Upper Limit of Normal) ULN.
  6. Distant Metastatic Disease limited to peritoneum and radiologically occult (not visualized on preoperative imaging to include [Computerized Tomography] CT scan, Ultrasound, [Magnetic Resonance Imaging] MRI, PET/CT): a. Positive peritoneal cytology; b. Carcinomatosis on diagnostic laparoscopy or laparotomy.
  7. Completion of preoperative systemic chemotherapy.

Exclusion Criteria:

  1. Distant metastatic disease not limited to peritoneum: a. Solid organ metastases (liver, central nervous system, lung).
  2. Any distant metastatic disease visualized on preoperative imaging: a. Solid organ metastases; b. Clear radiologic evidence of carcinomatosis.
  3. Infections such as pneumonia or wound infections that would preclude protocol therapy.
  4. Women with a positive urine or serum pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence.
  5. Subjects with unstable angina or New York Heart Association Grade II or greater congestive heart failure.
  6. Subjects deemed unable to comply with study and/or follow-up procedures.
  7. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Laparoscopic HIPEC consists of Mitomycin C 30 mg and Cisplatin 200 mg for 60 minutes, performed 2-8 weeks after completion of systemic chemotherapy. Loading dose Sodium Thiosulfate 7.5 gm/M2 infused prior to addition of Cisplatin to the peritoneal perfusion circuit. Then a maintenance infusion of Sodium Thiosulfate 25.56 gm/M2 delivered by infusion pump over 12 hours.
Drug: Mitomycin C
Mitomycin C 30 mg delivered laparoscopically for 60 minutes.
Other Names:
  • Mitomycin
Drug: Cisplatin
Cisplatin 200 mg delivered laparoscopically 60 minutes, 2-8 weeks after completion of systemic chemotherapy.
Other Names:
  • CDDP
  • Platinol
  • Platinol-AQ
Drug: Sodium Thiosulfate
Loading dose of 7.5 gm/M2 of Sodium Thiosulfate infused prior to addition of Cisplatin to the peritoneal perfusion circuit. Then a maintenance infusion of Sodium Thiosulfate 25.56 gm/M2 delivered by continuous infusion pump over 12 hours.
Other Names:
  • Tinver

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) After Hyperthermic Intraperitoneal Chemotherapy
Time Frame: Between the second and sixth week after treatment, up to 5 years
Primary objective of study is to assess overall survival (OS) in subjects with stage IV gastric cancer representing positive cytology or imaging occult carcinomatosis after laparoscopic hyperthermic intraperitoneal chemotherapy administration. Overall survival measured from time of laparoscopic HIPEC. Patterns of tumor recurrence and survival assessed by reviewing routine surveillance CT scans. Overall survival time estimated using the Kaplan-Meier method.
Between the second and sixth week after treatment, up to 5 years
Overall Survival (OS) From the First Laparoscopic HIPEC
Time Frame: From the day of surgery, until the last day of follow up, until death, up to 5 years
Primary objective of study is to assess overall survival (OS) in subjects with stage IV gastric cancer representing positive cytology or imaging occult carcinomatosis after the first laparoscopic HIPEC. Patterns of tumor recurrence and survival assessed by reviewing routine surveillance CT scans. Overall survival time estimated using the Kaplan-Meier method.
From the day of surgery, until the last day of follow up, until death, up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Brian D. Badgwell, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2014

Primary Completion (Actual)

May 12, 2020

Study Completion (Actual)

May 12, 2020

Study Registration Dates

First Submitted

March 18, 2014

First Submitted That Met QC Criteria

March 18, 2014

First Posted (Estimate)

March 20, 2014

Study Record Updates

Last Update Posted (Actual)

June 15, 2021

Last Update Submitted That Met QC Criteria

May 19, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-0989
  • NCI-2014-01105 (Registry Identifier: NCI CTRP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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