CompletedPhase 2

Laparoscopic Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) for Metastatic Gastric Cancer

United States21 participantsStarted 2014-05-08

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age 18 years and above. There will be no upper age restriction.
. Eastern Cooperative Oncology Group (ECOG) performance status \</= 2.
. Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction.
. 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.
. Hepatic function: AST (SGOT)/ALT (SGPT) \</= 5 X institutional (Upper Limit of Normal) ULN.
. 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.
. Completion of preoperative systemic chemotherapy.

Exclusion criteria

. Distant metastatic disease not limited to peritoneum: a. Solid organ metastases (liver, central nervous system, lung).
. Any distant metastatic disease visualized on preoperative imaging: a. Solid organ metastases; b. Clear radiologic evidence of carcinomatosis.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Overall Survival (OS) After Hyperthermic Intraperitoneal Chemotherapy

Timeframe: Between the second and sixth week after treatment, up to 5 years

Overall Survival (OS) From the First Laparoscopic HIPEC

Timeframe: From the day of surgery, until the last day of follow up, until death, up to 5 years

Trial details

NCT IDNCT02092298

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-05-12

Results submitted2020-11-24

View on ClinicalTrials.gov More Gastrointestinal Cancer trials