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Anti-metabolites

radiation therapy for Gastric Adenocarcinoma

Phase 2
Waitlist Available
Led By Michael McNamara, MD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have a histologic diagnosis of adenocarcinoma of the esophagus, GEJ, or GC based on biopsy material or adequate cytologic exam; tumors of the GC are defined as originating within 5 cm of the GEJ
Patients must be clinically staged according to the 7th edition (2010) of the American Joint Committee on Cancer (AJCC) staging system and must have either clinical T3-4a, or ≥ N1 disease; staging should include upper endoscopy with endoscopic ultrasound and a fludeoxyglucose (FDG)-positron emission tomography (PET)/computed tomography (CT) scan (with diagnostic CT abdomen/pelvis preferred)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat cancer of the esophagus, and will compare it to the standard of care.

Who is the study for?
This trial is for adults with specific cancers of the esophagus, gastroesophageal junction, or gastric cardia. They must be in good physical condition (ECOG 0-1), have adequate blood counts and organ function, and no severe neuropathy. Pregnant women, those with distant metastasis or another active cancer (with some exceptions), prior treatments for this cancer, certain infections like hepatitis B/C or HIV, serious heart conditions, or other medical issues that could affect participation are excluded.Check my eligibility
What is being tested?
The study tests a combination of chemotherapy drugs (oxaliplatin, leucovorin calcium, fluorouracil) followed by surgery and then more chemo alongside radiation therapy based on how well the patient responds to initial treatment. The goal is to see if this approach is effective at stopping tumor growth by killing cells or preventing them from dividing.See study design
What are the potential side effects?
Possible side effects include reactions to chemotherapy such as nausea, vomiting, diarrhea; low blood cell counts leading to increased infection risk; nerve damage causing numbness; fatigue; liver enzyme changes; and potential complications from radiation therapy like skin irritation and difficulty swallowing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is a type of adenocarcinoma located in my esophagus, GEJ, or stomach.
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My cancer is at a specific stage and has been confirmed with certain tests.
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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recurrence Free Survival (RFS) compared to historical averages
Secondary outcome measures
Complete resection (R0) rate
Endoscopic response
Incidence of toxicity
+6 more
Other outcome measures
Change in Ki-67 expression
Change in circulating tumor cells (CTCs)
HER2 overexpression
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Negative Pathologic ResponseExperimental Treatment7 Interventions
Patients with >50% viable tumor cells remaining in the surgical specimen, will receive postoperative chemo-radiotherapy with weekly carboplatin and paclitaxel.
Group II: Positive Pathologic ResponseActive Control5 Interventions
Patients with ≤50% viable tumor cells remaining in the surgical specimen will receive postoperative chemo-radiotherapy with the mFOLFOX6 regimen
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
radiation therapy
1994
Completed Phase 3
~13390
therapeutic conventional surgery
2003
Completed Phase 3
~12270
leucovorin calcium
1999
Completed Phase 3
~8620
paclitaxel
1996
Completed Phase 3
~4310
carboplatin
2010
Completed Phase 3
~4790
oxaliplatin
2002
Completed Phase 3
~6370
fluorouracil
1994
Completed Phase 3
~8440

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor
447 Previous Clinical Trials
31,291 Total Patients Enrolled
Michael McNamara, MDPrincipal InvestigatorCase Comprehensive Cancer Center
3 Previous Clinical Trials
277 Total Patients Enrolled

Media Library

Fluorouracil (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT02037048 — Phase 2
Gastric Adenocarcinoma Research Study Groups: Positive Pathologic Response, Negative Pathologic Response
Gastric Adenocarcinoma Clinical Trial 2023: Fluorouracil Highlights & Side Effects. Trial Name: NCT02037048 — Phase 2
Fluorouracil (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02037048 — Phase 2

Frequently Asked Questions

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

How many people suffering from this illness will be given the chance to try this new treatment?

"Currently, this clinical trial is not open for patient recruitment. The study was first posted on February 10th, 2014 with the latest update being July 25th, 2022. If you are interested in other trials, 994 studies involving stage iiia esophageal cancer and 1691 radiation therapy trials are actively recruiting patients."

Answered by AI

Could you please explain the risks associated with radiation treatments?

"While there is some evidence backing radiation therapy's safety, as this is only a Phase 2 trial, it receives a score of 2."

Answered by AI

Do you know of any other research that has looked at using radiation to treat patients?

"As of right now, there are 1691 on-going clinical trials researching radiation therapy. This includes 510 Phase 3 trials. The majority of these trials for radiation therapy are taking place in Guangzhou, Guangdong. However, there are a total of 88123 locations running studies related to this topic."

Answered by AI

Are there any opportunities for volunteers in this research?

"Presently, this trial is not enrolling patients. The listing was first made on February 10th, 2014 and updated as recently as July 25th, 2022. If you are looking for other stage iiia esophageal cancer studies, 994 trials are recruiting patients while 1691 research projects are actively searching for radiation therapy participants."

Answered by AI

What are some of the most frequent indications for radiation therapy?

"malignant neoplasms is often managed through radiation therapy. This same treatment can also help with other afflictions like rectal carcinoma, advanced gastric cancer, and conditioning regimens for allogeneic stem cell transplantation therapy."

Answered by AI
~6 spots leftby Mar 2025