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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

Must not have

Subjects with early stage gastric cancer (Stage T1/T2 N0)

Patients with known metastatic disease; this includes patients with clinically apparent or suspected metastasis to sites other than lymph nodes or peritoneal surfaces

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My gastric cancer is in the early stages (Stage 1 or 2, no spread to lymph nodes).

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My cancer has spread beyond lymph nodes or the lining of my abdomen.

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My lung condition does not limit my participation in studies.

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My surgeon found extensive scar tissue in my abdomen that prevents certain treatments.

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I am allergic to certain chemotherapy drugs like Carboplatin or Taxol.

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I have not had radiation therapy to my abdomen or pelvis.

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I am positive for HIV, Hepatitis B, or Hepatitis C.

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I do not have active heart disease and if I had it before, my recent heart test was normal.

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I have received treatment for my cancer before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pathological Response

Secondary study objectives

Disease

Overall Survival (OS)

Peritoneal Disease-free Survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2650

Famotidine

2005

Completed Phase 4

~1220