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Anti-metabolites

Chemotherapy + Radiation/Surgery for Stomach Cancer

Phase 2
Recruiting
Led By Quynh-Nhu Nguyen
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
The patient has a pathologic diagnosis of tumor biopsy or FNA of esophageal or gastric cancer of adenocarcinoma histology
The patient is staged with EGD and PET/CT scan
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights

Study Summary

This trial looks at how well chemotherapy works when given with radiation or surgery to people with esophageal or gastric cancer that has spread to no more than 3 places in the body.

Who is the study for?
This trial is for adults aged 18-80 with esophageal or gastric cancer that has spread to up to three places. They must have a life expectancy of at least six months, be able to perform daily activities (ECOG 0-2), and not have had previous chemotherapy or radiation for this cancer. Women must agree to use birth control during the study.Check my eligibility
What is being tested?
The trial is testing if adding radiation therapy or surgery to chemotherapy (with drugs like fluorouracil and capecitabine) provides better outcomes than chemotherapy alone in patients with limited-spread esophageal or gastric cancer.See study design
What are the potential side effects?
Chemotherapy may cause nausea, vomiting, hair loss, fatigue, and increased risk of infection. Radiation could lead to skin irritation and fatigue. Surgery risks include bleeding, infection, and reactions to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer in the esophagus or stomach is confirmed as adenocarcinoma.
Select...
My cancer stage was determined using EGD and PET/CT scans.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 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
Overall survival (OS)
Secondary outcome measures
Distant PFS
Incidence of adverse events
Local progression-free survival (PFS)
+1 more
Other outcome measures
Time to disease progression
Time to local disease recurrence

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group II (local therapy)Experimental Treatment5 Interventions
Participants receive fluorouracil and capecitabine and undergo RT per instructions of the treating physician in the absence of disease progression or unacceptable toxicity. Participants may also undergo surgery to some or all of the remaining sites of disease as is clinically prudent and indicated by treating physician.
Group II: Group I (maintenance chemotherapy)Experimental Treatment3 Interventions
Participants receive fluorouracil and capecitabine per instructions of the treating physician in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capecitabine
FDA approved
Chemotherapy
2003
Completed Phase 4
~3050
Fluorouracil
FDA approved
Radiation Therapy
2017
Completed Phase 3
~7250
Conventional Surgery
2006
Completed Phase 3
~1080

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,754 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,246 Total Patients Enrolled
Quynh-Nhu NguyenPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
316 Total Patients Enrolled

Media Library

Capecitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03161522 — Phase 2
Stomach Cancer Research Study Groups: Group I (maintenance chemotherapy), Group II (local therapy)
Stomach Cancer Clinical Trial 2023: Capecitabine Highlights & Side Effects. Trial Name: NCT03161522 — Phase 2
Capecitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03161522 — Phase 2

Frequently Asked Questions

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

What other previous trials have explored the use of Chemotherapy?

"Currently, there are 204 phase 3 trials and 591 active studies in total researching the efficacy of Chemotherapy. Most of these research sites exist in Adelaide, South Australia though there are 24767 laboratories across the world that have conducted clinical investigations into this treatment modality."

Answered by AI

Has Chemotherapy been given the green light by the Food and Drug Administration?

"We have given chemotherapy a score of 2 on our risk assessment scale, as there is evidence that the treatment is safe but no proof yet of its effectiveness."

Answered by AI

To what diseases and illnesses is Chemotherapy typically administered?

"Superficial basal cell carcinoma is often managed with chemotherapy, and this form of treatment may also be advantageous for individuals dealing with rectal carcinoma, metastatic colorectal carcinoma, or pancreatic endocrine carcinoma."

Answered by AI

Am I eligible to be a participant in this clinical experiment?

"This clinical trial seeks to enrol 100 individuals with malignant stomach neoplasms, ranging in ages from 18 to 79. These participants must meet the following criteria: (1) ECOG performance status 0-2 and a life expectancy of at least 6 months; (2) three or fewer metastatic lesions observable on PET/CT scan; (3) pathologic diagnosis of tumor biopsy or FNA confirming adenocarcinoma histology; (4) women of childbearing age need to have pregnancy test conducted prior to enrollment and agree to use adequate contraception for duration of study plus an additional six months after discontinuation of systemic"

Answered by AI

Is enrollment still available for this trial?

"Affirmative. Documentation on clinicaltrials.gov confirms that this medical investigation is actively searching for participants, having been posted to the website in February 2018 and adjusted as recently as September 2022. This research needs roughly one hundred volunteers from a single location."

Answered by AI

Does this medical trial include individuals over twenty-five years of age as participants?

"Qualified patients for this research require to be between 18 and 79 years of age. Additionally, there are 35 studies available for minors and 1761 trials designed for those aged 65 or older."

Answered by AI

How many participants have been selected for this research endeavor?

"Indeed, the information on clinicaltrials.gov reveals that this experiment is currently seeking participants. This study was initially shared on February 19th 2018 and has been revised most recently on September 20th 2022. 100 candidates need to be sourced from 1 medical facility for this trial to progress."

Answered by AI
~30 spots leftby Dec 2026