Adjuvant Hyperthermic Intraperitoneal Chemotherapy for Locally Advanced Gastric Cancer

April 10, 2019 updated by: Maheswari Senthil, Loma Linda University
The purpose of this study is to determine safety and feasibility of adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) with mitomycin and cisplatin in patients with locally advanced gastric cancer undergoing standard surgical resection. Patients will be treated with HIPEC using a single dose of mitomycin 15mg/m2 and cisplatin 50mg/m2 at 41-42 C for 90 minutes, during the definitive surgical resection for gastric cancer. HIPEC will be performed after resection but before anastomosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Treatment Plan:

Patients undergoing definitive resection for gastric cancer and meeting the eligibility criteria will be treated with HIPEC using a single dose of Mitomycin 15mg/m2 and Cisplatin 50mg/m2 at 41-42 C for 90 minutes. HIPEC will be performed after resection but before anastomosis. Both Cisplatin and Mitomycin are commercially available chemotherapeutic agents and will be obtained as marketed drugs.

Outcome Measures:

Patients will be followed for 90 days following surgery. All postoperative complications will be recorded and graded according to the modified Clavien-Dindo classification.

Schedule for Follow Up:

Trial-related patient assessments will be performed daily while the patient remains in the hospital for postoperative care, and then during postoperative clinic visits. The final postoperative clinic visit for evaluation of study outcomes and complications should occur between postoperative days 90 and 95 to allow for a cumulative assessment of the patient's perioperative complications, if any.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 1

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
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University 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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients aged 18-75 with biopsy-proven gastric adenocarcinoma
  2. Tumor clinically staged T3 or T4 and/or nodes staged clinically positive
  3. ECOG performance status < 2

Exclusion Criteria:

  1. Distant metastases
  2. Peritoneal carcinomatosis
  3. Synchronous malignancy
  4. Tumors at the gastroesophageal junction
  5. Recurrent gastric adenocarcinoma
  6. Creatinine >/= 1.5
  7. Bilirubin >/= 2
  8. INR >/= 2
  9. Allergy to drugs included in the treatment plan
  10. Pregnancy
  11. Contraindication to major surgery

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: HIPEC
The administration of hyperthermic intraperitoneal chemotherapy (HIPEC), using a warm solution of two chemotherapy medications (mitomycin and cisplatin) to bathe the internal surfaces of the abdomen in an attempt to kill any microscopic cancer cells that might be present on these surfaces.
Drug: Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Hyperthermic intraperitoneal chemotherapy (HIPEC) is a procedure in which the internal parts of the abdomen are bathed in a warm solution of anti-cancer medications for 90 minutes.
Other Names:
  • HIPEC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post Operative Complications
Time Frame: 90 days following surgery
Patients will be followed for 90 days following surgery. Postoperative complications will be recorded and graded according to the modified Clavien-Dindo classification.
90 days following surgery

Collaborators and Investigators

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

Sponsor

Loma Linda University

Investigators

  • Principal Investigator: Maheswari Senthil, MD, Loma Linda University 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

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)

February 2, 2016

Primary Completion (Actual)

October 3, 2018

Study Completion (Actual)

October 3, 2018

Study Registration Dates

First Submitted

February 2, 2016

First Submitted That Met QC Criteria

February 2, 2016

First Posted (Estimate)

February 3, 2016

Study Record Updates

Last Update Posted (Actual)

April 12, 2019

Last Update Submitted That Met QC Criteria

April 10, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5150301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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