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Anti-metabolites

Chemoradiotherapy + Chemotherapy for Gastric Cancer

Phase 1

Waitlist Available

Led By Brian D Badgwell

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

Patients with a biopsy-confirmed diagnosis of adenocarcinoma of the stomach

Glomerular filtration rate >= 60 mL/min/1.73 m^2. The estimated glomerular filtration rate (eGFR) is calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. The eGFR declines with age. eGFR < 60 mL/min/1.73 m2 is considered as 'decreased'. This equation should only be used for patients 18 and older. According to the National Kidney Foundation's Kidney Disease Outcome Quality Initiative (KDOQI) classification and 2012 Kidney Disease Improving Global Outcomes (KDIGO) Clinical Practice Guideline, the stage of CKD should be categorized based on estimated GFR

Must not have

Comorbid conditions (examples - collagen vascular diseases, certain genetic conditions that predispose to secondary malignancies) that are prohibitive to preoperative therapy, or contraindications to radiotherapy

Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial is investigating whether a shorter course of chemotherapy and radiation treatment followed by standard chemotherapy is effective in treating gastric cancer.

Who is the study for?

This trial is for adults with confirmed gastric adenocarcinoma who are fit enough for chemotherapy and surgery, have a good kidney function (eGFR >= 60 mL/min/1.73 m^2), no distant cancer spread, and an ECOG performance status of <=2. Pregnant women, those unable to follow the study plan, people with life-threatening reactions to similar chemo drugs or prior radiotherapy in the same area, and individuals with certain health conditions that make treatment risky are excluded.

What is being tested?

The trial tests if a shorter course of chemoradiotherapy over 2 weeks followed by standard chemotherapy before surgery can effectively treat stomach cancer. It uses capecitabine and fluorouracil—drugs that target tumor cells—to see if this approach better controls the disease compared to longer treatments.

What are the potential side effects?

Potential side effects include typical reactions to chemotherapy like nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems. Radiation may cause skin irritation at the treatment site and gastrointestinal symptoms such as diarrhea.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with stomach cancer through a biopsy.

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My kidney function is normal or only mildly reduced.

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My cancer is at least stage T2 or has spread to the lymph nodes.

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I can take care of myself and perform daily activities.

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My cancer has not spread to distant parts of my body according to recent scans.

Exclusion Criteria

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

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I have health conditions that prevent me from receiving certain cancer treatments.

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I've had a severe allergic reaction to chemotherapy before.

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I have had radiation treatment to the same area before.

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I do not have infections like pneumonia that would stop me from following the treatment plan.

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I have severe heart problems, including unstable chest pain or heart failure.

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I have a condition that affects how my body absorbs nutrients.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Incidence of adverse events

Secondary study objectives

Overall survival (OS)

Rate of pathologic complete response in patients treated with resection

Rate of perioperative complications after gastrectomy in patients treated with preoperative short course CXRT and chemotherapy

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

1Treatment groups

Experimental Treatment

Group I: Treatment (CXRT, chemotherapy, surgery)Experimental Treatment4 Interventions

Patients receive CXRT consisting of radiation therapy 5 days a week (Monday through Friday) for 2 weeks (10 treatments) and standard of care chemotherapy consisting of capecitabine PO BID or fluorouracil IV continuous Monday to Friday of each radiation week. About 2 weeks later, patients receive standard of care chemotherapy for up to 2 months in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery 3-8 weeks post-chemotherapy completion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fluorouracil

FDA approved

Radiation Therapy

2017

Completed Phase 3

~7250

Capecitabine

FDA approved