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Neoadjuvant Therapy for Stomach Cancer

Phase 1

Waitlist Available

Led By Dayssy A Diaz Pardo, MD, MS

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

T1 N0 disease (assessed by endoscopic ultrasound)

Patient should be eligible for surgical intervention

Must not have

Evidence of distant metastatic disease

Peripheral polyneuropathy > National Cancer Institute (NCI) grade II

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 25 months

Awards & highlights

Approved for 10 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing the safety of giving chemotherapy drugs followed by chemoradiation before surgery in treating patients with stomach or gastroesophageal junction cancer.

Who is the study for?

This trial is for adults with certain stages of stomach or gastroesophageal junction cancer, who are fit enough for surgery and chemotherapy. They should not have distant spread of cancer, severe neuropathy, or only one working kidney in the radiation area.

What is being tested?

The study tests if giving chemotherapy (with drugs like docetaxel and oxaliplatin) followed by chemoradiation before surgery can safely shrink tumors in patients with gastric or gastroesophageal junction cancer.

What are the potential side effects?

Possible side effects include reactions to chemotherapy such as nausea, fatigue, hair loss; nerve damage from drugs like oxaliplatin; and skin irritation or other issues related to radiation therapy.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is early stage and has not spread to lymph nodes.

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I am eligible for surgery.

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My cancer is a specific type of stomach or junction cancer that has not spread to distant organs.

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I can take care of myself but might not be able to do heavy physical work.

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I am 18 years old or older.

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I am eligible for specific chemotherapy treatments before surgery.

Exclusion Criteria

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

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My cancer has spread to distant parts of my body.

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My nerve damage does not severely limit my daily activities.

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I have only one working kidney that might be affected by radiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 25 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 25 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 25 months for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Overall survival (OS)

Perfusion and early tumor uptake kinetics of primary tumor using 8F-FDG dPET/CT approaches

Progression-free survival (PFS)

Other study objectives

Standard uptake value SUVmax Tumor-to-liver metrics

Standard uptake value SUVmax metrics

Standard uptake value SUVpeak Tumor-to-liver metrics

+1 more

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

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

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 (chemotherapy, chemoradiation, surgery)Experimental Treatment7 Interventions

NEOADJUVANT CHEMOTHERAPY: Patients receive FLOT chemotherapy consisting of docetaxel intravenously (IV) , oxaliplatin IV, leucovorin IV, and fluorouracil IV over 24 hours on day 1 or FOLFOX chemotherapy consisting of oxaliplatin IV and leucovorin IV, and fluorouracil IV continuously over 24 hours on days 1 and 2. Treatment repeats every 2 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. NEOADJUVANT CHEMORADIATION: Within 4 weeks after completing neoadjuvant chemotherapy, patients undergo radiation therapy in 25 fractions over 5 weeks. Patients also receive either fluorouracil IV continuously for 24 hours on days 1-5 or capecitabine orally (PO) twice daily (BID) on days 1-5. Cycles repeat weekly for 5 weeks in the absence of disease progression or unacceptable toxicity. SURGERY: Within 4-8 weeks after neoadjuvant chemoradiation, patients undergo surgical resection according to tumor location and per surgeon expertise.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Capecitabine

FDA approved

Docetaxel

FDA approved

Fluorouracil

FDA approved

Oxaliplatin

FDA approved