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Radiation Therapy
HIPEC + Chemoradiation for Stomach Cancer
Phase 2
Recruiting
Led By Spiros Hiotis, MD, PhD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG Scale of Performance Status of 0-2
Patient must plan to undergo surgical treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 years
Awards & highlights
Study Summary
This trial is testing a new, multi-modality approach to treating stomach cancer that involves diagnostic laparoscopy with HIPEC, neoadjuvant chemo-radiotherapy, followed by surgical resection and adjuvant chemotherapy. The goal is to assess if this approach leads to a pathological complete response; decreased rates of disease progression during neoadjuvant therapy; and increased overall, disease-free, and peritoneal disease-free survival.
Who is the study for?
This trial is for adults with advanced gastric cancer (T3/T4, N0/+), who haven't had previous cancer treatments and are planning surgery. They must be physically well enough to participate, not pregnant or nursing, without HIV/Hepatitis B/C, and have no history of severe allergies to the study drugs.Check my eligibility
What is being tested?
The trial tests a combination treatment for stomach cancer: HIPEC during diagnostic laparoscopy, neoadjuvant chemo-radiotherapy before surgery, followed by more chemotherapy. It aims to see if this approach can improve survival rates and reduce disease progression.See study design
What are the potential side effects?
Possible side effects include allergic reactions to chemotherapy drugs like Carboplatin and Paclitaxel; fatigue; nausea; blood disorders; kidney or liver function changes; risk of infection due to low white blood cell counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to get out of my bed or chair and move around.
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I am planning to have surgery for my condition.
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My blood counts and liver/kidney functions are within normal ranges.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pathological Response
Secondary outcome measures
Disease
Overall Survival (OS)
Peritoneal Disease-free Survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: Patients With Local Regional Advanced Gastric CancerExperimental Treatment9 Interventions
Patients with local regional advanced gastric cancer after at least 4 weeks post diagnostic laparoscopy and HIPEC, will receive all of the treatments described in the study protocol.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Surgical resection
2021
Completed Phase 2
~920
Adjuvant Chemotherapy
2015
Completed Phase 2
~20
Carboplatin
2014
Completed Phase 3
~6670
Diphenhydramine
2002
Completed Phase 4
~1170
Palonosetron
2011
Completed Phase 4
~4470
Famotidine
2005
Completed Phase 4
~1700
Paclitaxel
2011
Completed Phase 4
~5380
Find a Location
Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
860 Previous Clinical Trials
524,447 Total Patients Enrolled
Spiros Hiotis, MD, PhD3.512 ReviewsPrincipal Investigator - Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
5Patient Review
This doctor is very professional and seems to genuinely care about their patients.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My gastric cancer is in the early stages (Stage 1 or 2, no spread to lymph nodes).My cancer has spread beyond lymph nodes or the lining of my abdomen.My lung condition does not limit my participation in studies.I am able to get out of my bed or chair and move around.My stomach cancer is at an advanced stage but hasn't spread to distant organs.My surgeon found extensive scar tissue in my abdomen that prevents certain treatments.I am allergic to certain chemotherapy drugs like Carboplatin or Taxol.I do not have severe health issues that would prevent me from fully participating in the study.I had cancer before, but it was either skin cancer that's cured, cervical cancer treated without spreading, or any cancer that hasn't shown signs for over 3 years.I have not had radiation therapy to my abdomen or pelvis.I am positive for HIV, Hepatitis B, or Hepatitis C.I do not have active heart disease and if I had it before, my recent heart test was normal.I am planning to have surgery for my condition.I do not have a history of stroke or brain blood vessel issues that would stop me from safely participating in the study.My blood counts and liver/kidney functions are within normal ranges.I have received treatment for my cancer before.
Research Study Groups:
This trial has the following groups:- Group 1: Patients With Local Regional Advanced Gastric Cancer
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the FDA give its approval to Adjuvant Chemotherapy?
"Despite lacking evidence of therapeutic efficacy, Adjuvant Chemotherapy has been assigned a safety rating of 2 due to the existence of some corresponding clinical data."
Answered by AI
Are there openings for enrolment in this experiment?
"Affirmative. According to clinicaltrials.gov, the trial first opened on July 31st 2018 and is currently searching for 29 participants from 3 distinct sites. Recent edits were made on December 7th 2021."
Answered by AI
For what ailments is Adjuvant Chemotherapy commonly prescribed?
"Adjuvant Chemotherapy is often prescribed to treat synovitis, as well as metastatic bladder cancer, pain, and advanced testicular cancer."
Answered by AI
What is the current size of the participant pool in this clinical trial?
"Yes, evidence on clinicaltrials.gov reveals that this research endeavour is presently enrolling participants. It was initially published in July of 2018 and most recently updated in December of 2021 with a target recruitment goal of 29 people from three centers."
Answered by AI
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