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Anti-metabolites
Chemoradiotherapy + Chemotherapy for Gastric Cancer
Phase 1
Waitlist Available
Led By Brian D Badgwell
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
Patients with a biopsy-confirmed diagnosis of adenocarcinoma of the stomach
Glomerular filtration rate >= 60 mL/min/1.73 m^2. The estimated glomerular filtration rate (eGFR) is calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. The eGFR declines with age. eGFR < 60 mL/min/1.73 m2 is considered as 'decreased'. This equation should only be used for patients 18 and older. According to the National Kidney Foundation's Kidney Disease Outcome Quality Initiative (KDOQI) classification and 2012 Kidney Disease Improving Global Outcomes (KDIGO) Clinical Practice Guideline, the stage of CKD should be categorized based on estimated GFR
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is investigating whether a shorter course of chemotherapy and radiation treatment followed by standard chemotherapy is effective in treating gastric cancer.
Who is the study for?
This trial is for adults with confirmed gastric adenocarcinoma who are fit enough for chemotherapy and surgery, have a good kidney function (eGFR >= 60 mL/min/1.73 m^2), no distant cancer spread, and an ECOG performance status of <=2. Pregnant women, those unable to follow the study plan, people with life-threatening reactions to similar chemo drugs or prior radiotherapy in the same area, and individuals with certain health conditions that make treatment risky are excluded.Check my eligibility
What is being tested?
The trial tests if a shorter course of chemoradiotherapy over 2 weeks followed by standard chemotherapy before surgery can effectively treat stomach cancer. It uses capecitabine and fluorouracil—drugs that target tumor cells—to see if this approach better controls the disease compared to longer treatments.See study design
What are the potential side effects?
Potential side effects include typical reactions to chemotherapy like nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems. Radiation may cause skin irritation at the treatment site and gastrointestinal symptoms such as diarrhea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with stomach cancer through a biopsy.
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My kidney function is normal or only mildly reduced.
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My cancer is at least stage T2 or has spread to the lymph nodes.
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I can take care of myself and perform daily activities.
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My cancer has not spread to distant parts of my body according to recent scans.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Overall survival (OS)
Rate of pathologic complete response in patients treated with resection
Rate of perioperative complications after gastrectomy in patients treated with preoperative short course CXRT and chemotherapy
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (CXRT, chemotherapy, surgery)Experimental Treatment4 Interventions
Patients receive CXRT consisting of radiation therapy 5 days a week (Monday through Friday) for 2 weeks (10 treatments) and standard of care chemotherapy consisting of capecitabine PO BID or fluorouracil IV continuous Monday to Friday of each radiation week. About 2 weeks later, patients receive standard of care chemotherapy for up to 2 months in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery 3-8 weeks post-chemotherapy completion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluorouracil
FDA approved
Radiation Therapy
2017
Completed Phase 3
~7250
Capecitabine
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,638 Previous Clinical Trials
40,929,794 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,965 Previous Clinical Trials
1,804,435 Total Patients Enrolled
Brian D BadgwellPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
51 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My scans show cancer has spread, but I haven't had or can't have a laparoscopy due to past surgery.I have been diagnosed with stomach cancer through a biopsy.I have health conditions that prevent me from receiving certain cancer treatments.My kidney function is normal or only mildly reduced.My cancer is at least stage T2 or has spread to the lymph nodes.I am not pregnant, will not breastfeed, and will use effective birth control.I've had a severe allergic reaction to chemotherapy before.I can follow the study's requirements and attend all follow-up visits.I have had radiation treatment to the same area before.I can take care of myself and perform daily activities.My cancer has not spread to distant parts of my body according to recent scans.I do not have infections like pneumonia that would stop me from following the treatment plan.I have severe heart problems, including unstable chest pain or heart failure.I have a condition that affects how my body absorbs nutrients.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (CXRT, chemotherapy, surgery)
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research actively seeking participants?
"Clinicaltrials.gov confirms that this medical trial is actively seeking new participants, with the original post date dating to 11 August 2020 and a recent update on 19 August 2020."
Answered by AI
To what diseases is Radiation Therapy chiefly administered?
"Radiation Therapy is a viable treatment plan for superficial basal cell carcinoma, rectal carcinoma, and metastatic colorectal carcinoma."
Answered by AI
What is the current patient participation rate for this trial?
"Affirmative, the information posted on clinicaltrials.gov suggests that this analysis is currently recruiting participants. The trial began to be advertised on August 11th 2020 and was most recently updated in the same month on the 19th day of August. 30 test subjects are needed from a single site for this investigation."
Answered by AI
Has the FDA sanctioned Radiation Therapy?
"Taking into consideration that this is a Phase 1 trial, our team at Power has assigned Radiation Therapy a tentative safety rating of one due to the limited amount of evidence surrounding its efficacy and security."
Answered by AI
Have any other research endeavours explored the effectiveness of Radiation Therapy?
"Presently, there are 591 live trials investigating the use of Radiation Therapy with 204 being in Phase 3. Most studies have been conducted out of Adelaide, South Australia but 24807 different sites have hosted such medical research."
Answered by AI
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