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Anti-metabolites

Chemotherapy + Radiation/Surgery for Stomach Cancer

Phase 2

Recruiting

Led By Quynh-Nhu Nguyen

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The patient has a pathologic diagnosis of tumor biopsy or FNA of esophageal or gastric cancer of adenocarcinoma histology

The patient is staged with EGD and PET/CT scan

Must not have

Patients established to have a tumor with Microsatellite Instability High (MSIH) status.

Patients known or suspected to have a dihydropyrimidine dehydrogenase deficiency (as these patients are at a greater risk of experiencing symptoms of toxicity)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial looks at how well chemotherapy works when given with radiation or surgery to people with esophageal or gastric cancer that has spread to no more than 3 places in the body.

Who is the study for?

This trial is for adults aged 18-80 with esophageal or gastric cancer that has spread to up to three places. They must have a life expectancy of at least six months, be able to perform daily activities (ECOG 0-2), and not have had previous chemotherapy or radiation for this cancer. Women must agree to use birth control during the study.

What is being tested?

The trial is testing if adding radiation therapy or surgery to chemotherapy (with drugs like fluorouracil and capecitabine) provides better outcomes than chemotherapy alone in patients with limited-spread esophageal or gastric cancer.

What are the potential side effects?

Chemotherapy may cause nausea, vomiting, hair loss, fatigue, and increased risk of infection. Radiation could lead to skin irritation and fatigue. Surgery risks include bleeding, infection, and reactions to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer in the esophagus or stomach is confirmed as adenocarcinoma.

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My cancer stage was determined using EGD and PET/CT scans.

Exclusion Criteria

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

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My tumor is MSI-High.

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I am at risk for severe side effects due to a specific enzyme deficiency.

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My doctor expects I have more than 6 months to live and I can care for myself.

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My bone marrow does not work well.

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I am currently dealing with a serious infection.

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I have had serious heart issues like uncontrolled chest pain, heart failure, or a heart attack in the last 6 months.

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I am not pregnant, as confirmed by a bHCG lab test.

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I am currently breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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

Overall survival (OS)

Secondary study objectives

Distant PFS

Incidence of adverse events

Local progression-free survival (PFS)

+1 more

Other study objectives

Time to disease progression

Time to local disease recurrence

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group II (local therapy)Experimental Treatment5 Interventions

Participants receive fluorouracil and capecitabine and undergo RT per instructions of the treating physician in the absence of disease progression or unacceptable toxicity. Participants may also undergo surgery to some or all of the remaining sites of disease as is clinically prudent and indicated by treating physician.

Group II: Group I (maintenance chemotherapy)Experimental Treatment3 Interventions

Participants receive fluorouracil and capecitabine per instructions of the treating physician in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Chemotherapy

2003

Completed Phase 4

~3050

Radiation Therapy

2017

Completed Phase 3

~7250