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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
Anatomically defined lymphadenopathy will be considered as 1 site of metastatic disease. Intrathoracic nodes, defined as hilar and mediastinal nodes, will be collectively counted as one
Women of childbearing potential and sexually active males must use accepted and effective methods of contraception or abstain from sexual intercourse for a specified period after the last dose of protocol treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years post treatment
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 the lymph nodes in my chest.
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I am using or willing to use effective birth control after my last treatment dose.
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I am HIV-positive, on effective treatment, and my viral load is undetectable. My CD4 count is above 200.
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I had my last major surgery more than 4 weeks ago.
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My cancer has spread to no more than 3 places, not counting where it started.
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I have another cancer, but it won't affect this trial's treatment.
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My cancer hasn't worsened since my last check-up according to scans.
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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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My early stage cancer returned 6 months after completing all 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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival
Secondary outcome measures
Incidence of adverse events
Progression-free survival

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
~3420
Fluorouracil
2014
Completed Phase 3
~11540
Leucovorin
2005
Completed Phase 4
~5730
Leucovorin Calcium
2011
Completed Phase 3
~12290
Oxaliplatin
2011
Completed Phase 4
~2560
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor
116 Previous Clinical Trials
176,608 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,027 Total Patients Enrolled
Nataliya V UbohaPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Capecitabine (Antimetabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04248452 — Phase 3
Esophageal Adenocarcinoma Research Study Groups: Arm A (FOLXFOX), Arm B (CAPOX), Arm C (radiation therapy, FOLFOX), Arm D (FOLFOX), Arm E (radiation therapy, CAPOX), Arm F (CAPOX)
Esophageal Adenocarcinoma Clinical Trial 2023: Capecitabine Highlights & Side Effects. Trial Name: NCT04248452 — Phase 3
Capecitabine (Antimetabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04248452 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the primary reasons that people receive Radiation Therapy?

"While commonly used to treat refractory fallopian tube carcinoma, radiation therapy can also be an effective treatment for conditions like rectal carcinoma, osteoporosis, and certain types of joint pain."

Answered by AI

Has Radiation Therapy undergone the FDA's rigorous testing process?

"Radiation Therapy received a score of 3 because there is some evidence from Phase 3 clinical trials to suggest its efficacy, as well as multiple rounds of data that support its safety."

Answered by AI

Does this research stand on its own, or has there been prior experimentation with Radiation Therapy?

"Presently, there are 789 clinical trials studying Radiation Therapy. Of those, 262 are in Phase 3. Though the majority of these trials for Radiation Therapy originate in Guangzhou, Guangdong, there are 31133 locations running studies for this treatment worldwide."

Answered by AI

Are there any remaining places open for people in this clinical trial?

"The clinical trial is currently looking for patients, with the first posting on 2/6/2020 and the last update on 7/26/2022. The study is recruiting for 314 participants between 100 sites."

Answered by AI

At how many hospitals is this research being conducted?

"In addition to the three primary sites of Alliance for Childhood Diseases/Cure 4 the Kids Foundation in Las Vegas, Nevada, Advanced Breast Care Center PLLC in Warren, Washington, and Michigan Breast Specialists-Warren in Henderson, Illinois, this study is also taking place at 100 other locations."

Answered by AI

How many people are allowed to participate in this trial?

"A total of 314 individuals who meet the eligibility requirements must enroll in this clinical trial. Patients can receive treatment at various sites, such as Alliance for Childhood Diseases/Cure 4 the Kids Foundation in Las Vegas, Nevada and Advanced Breast Care Center PLLC in Warren, Washington."

Answered by AI
~160 spots leftby Mar 2028