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Study of Cytoreduction, Gastrectomy, & Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology

2016-09-07 16:23:21 | BioPortfolio

Summary

The goal of this clinical research study is to learn whether cytoreduction surgery (surgery to reduce or remove lesions), gastrectomy (where all or part of the stomach is removed), and hyperthermic intraperitoneal chemoperfusion (HIPEC, a heated chemotherapy treatment delivered directly inside the abdomen during surgery) can help control the disease in patients with gastric and/or gastroesophageal cancer. The safety of these procedures will also be studied.

Description

Study Procedures:

If they are eligible and agree to take part, participants will have the following procedures:

- Standard-of-care cytoreduction surgery

- Standard-of-care gastrectomy

- HIPEC treatment during surgery, where they will receive mitomycin and cisplatin over about 60 minutes. HIPEC treatment surgery means they will receive mitomycin and cisplatin over about 60 minutes. Heated mitomycin and cisplatin will be delivered through plastic tubing that is connected to a pump into the abdominal cavity. The pump pushes the heated mitomycin and cisplatin into the abdominal cavity and then pulls it out and recirculates the mitomycin and cisplatin. The skin of the abdominal cavity is temporarily closed during the abdominal wash. A pump will be used to pump the heated mitomycin and cisplatin in and out of the abdominal cavity over 60 minutes while the surgeon gently presses on the abdominal wall so the mitomycin and cisplatin reaches all areas in the abdominal cavity. After 60 minutes, the mitomycin and cisplatin is removed and the abdominal cavity will be washed. The remaining fluid will be removed before the surgeon permanently closes the abdominal cavity with stitches.

- They will also receive sodium thiosulfate to help protect the kidneys and lower the risk of side effects from cisplatin.

They will sign separate consents for the cytoreduction and the gastrectomy that will explain what is done and the risks involved.

Length of Study Participation:

Their active participation in this study will be over after their surgery.

Follow Up:

Within 4 weeks after their surgery and again every 6 months after that, they will visit the clinic or be called on the phone. They will be asked how they are feeling and if they are having any problems. If they are called, these calls should last about 5 minutes.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Gastroesophageal Cancer

Intervention

Hyperthermic intraperitoneal chemoperfusion (HIPEC), Sodium thiosulfate

Location

The University of Texas MD Anderson Cancer Center
Houston
Texas
United States
77030

Status

Recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-09-07T16:23:21-0400

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Medical and Biotech [MESH] Definitions

A sodium salt of gold thiosulfate. It has uses like the ORGANOGOLD COMPOUNDS.

An enzyme that catalyzes the transfer of the planetary sulfur atom of thiosulfate ion to cyanide ion to form thiocyanate ion. EC 2.8.1.1.

Sodium or sodium compounds used in foods or as a food. The most frequently used compounds are sodium chloride or sodium glutamate.

A voltage-gated sodium channel subtype that mediates the sodium ion PERMEABILITY of CARDIOMYOCYTES. Defects in the SCN5A gene, which codes for the alpha subunit of this sodium channel, are associated with a variety of CARDIAC DISEASES that result from loss of sodium channel function.

Stable sodium atoms that have the same atomic number as the element sodium, but differ in atomic weight. Na-23 is a stable sodium isotope.

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