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Antimetabolites

Chemotherapy + Radiotherapy for Esophageal and Gastric Cancer

Phase 3

Recruiting

Led By Nataliya V Uboha

Research Sponsored by ECOG-ACRIN Cancer Research Group

Eligibility Criteria Checklist

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

Must have

Patient must have oligometastatic disease at the time of registration, which is defined as having at most 3 radiologically visible metastatic lesions (not sites), in addition to the primary site. Malignant lymph node should be at least 1 cm in size or biopsy proven involved by disease

Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Must not have

Patient must not have had any prior treatment with 5-FU or capecitabine and/or oxaliplatin containing systemic therapy

Patient must not have any uncontrolled intercurrent illness including ongoing or active infection requiring treatment, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years post treatment

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is studying how well adding radiotherapy to the usual chemotherapy treatment works compared to the usual treatment alone in treating patients with esophageal and gastric cancer.

Who is the study for?

This trial is for adults with HER2 negative esophageal or gastric adenocarcinoma that has spread to up to 3 other body parts. They should have stable disease after certain chemotherapy treatments and be in good physical condition (ECOG 0-1). Participants need functioning major organs, not be pregnant or breastfeeding, and agree to use contraception. Those with uncontrolled illnesses, CNS metastasis, prior adverse reactions to the study drugs, or recent live vaccines cannot join.

What is being tested?

The study is testing if adding radiotherapy (high energy rays) to standard chemotherapy (leucovorin calcium, fluorouracil/5-FU, oxaliplatin) improves outcomes for patients with limited-spread esophageal and gastric cancer compared to chemotherapy alone. It's a phase III trial where participants are randomly assigned treatment options.

What are the potential side effects?

Possible side effects include radiation-related skin changes and fatigue; nausea; diarrhea from capecitabine; low blood counts leading to infection risk from fluorouracil; nerve damage causing numbness or tingling from oxaliplatin; mouth sores and loss of appetite.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has spread to no more than 3 places, not counting where it started.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My stomach or esophagus cancer is not HER2 positive and has not worsened after specific chemotherapy treatments.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer is HER2 negative and has spread from my esophagus or stomach.

Exclusion Criteria

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

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I have never been treated with 5-FU, capecitabine, or oxaliplatin.

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I do not have any serious illnesses or infections that are not under control.

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I am not pregnant or breastfeeding.

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I do not have cancer that has spread to my brain or spinal cord.

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I have no allergies or adverse reactions to 5-FU, capecitabine, or oxaliplatin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years post treatment

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

Treatment Details

Study Objectives

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

Secondary study objectives

Incidence of adverse events

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

6Treatment groups

Experimental Treatment

Active Control

Group I: Arm E (radiation therapy, CAPOX)Experimental Treatment3 Interventions

One week post induction of patients in ARM B, patients undergo radiation therapy for up to 15 days. Within 2-4 weeks post radiation therapy, patients receive oxaliplatin and capecitabine as in Arm B for 2 years in the absence of disease progression or unacceptable toxicity.

Group II: Arm C (radiation therapy, FOLFOX)Experimental Treatment5 Interventions

One week post induction of patients in ARM A, patients undergo radiation therapy for up to 15 days. Within 2-4 weeks post radiation therapy, patients receive oxaliplatin, leucovorin, and 5-fluorouracil as in Arm A for 2 years in the absence of disease progression or unacceptable toxicity.

Group III: Arm B (CAPOX)Experimental Treatment2 Interventions

Patients receive oxaliplatin IV over 2 hours on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Group IV: Arm A (FOLXFOX)Experimental Treatment4 Interventions

Patients receive oxaliplatin IV over 1.5 hours, leucovorin IV over 1.5 hours, and 5-fluorouracil IV over 46-48 hours on days 1 and 15. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

Group V: Arm D (FOLFOX)Active Control4 Interventions

Post induction of patients in ARM A, patients continue oxaliplatin, leucovorin, and 5-fluorouracil as in Arm A for 2 years in the absence of disease progression or unacceptable toxicity.

Group VI: Arm F (CAPOX)Active Control2 Interventions

Post induction of patients in ARM B, patients continue oxaliplatin and capecitabine as in Arm B for 2 years in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Capecitabine

2013

Completed Phase 3

~4280

Fluorouracil

2014

Completed Phase 3

~11700