Chemoradiotherapy + Chemotherapy for Gastric Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase Ib trial investigates the side effects and how well a shorter course of chemotherapy and radiation treatment (chemoradiotherapy) for 2 weeks instead of 5 weeks followed by standard chemotherapy works in treating patients with gastric cancer who are scheduled to have treatment and then surgery to remove the tumor. Chemotherapy drugs, such as capecitabine and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy sources to kill tumor cells and shrink tumors. Giving short-course chemo-radiotherapy before chemotherapy and surgery may help to control the disease.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is the combination of capecitabine and radiation therapy generally safe for humans?
Capecitabine, an oral form of chemotherapy, is generally considered safe and is preferred by many patients because it can be taken at home. It has a favorable safety profile, with common side effects including hand-foot syndrome (redness and swelling of the hands and feet), mouth sores, and diarrhea. Combining capecitabine with radiation therapy has shown promise in treating various cancers, with ongoing studies to further evaluate its safety and effectiveness.12345
How does the treatment of Capecitabine with radiation therapy differ from other treatments for gastric cancer?
This treatment is unique because Capecitabine is an oral drug that is selectively activated in tumor tissues, making it more convenient and potentially more effective than the traditional 5-Fluorouracil (5-FU) infusion. It enhances the effect of radiation therapy by increasing the concentration of the active drug in cancer cells, which may improve treatment outcomes.25678
What data supports the effectiveness of the drug Capecitabine (Xeloda) with radiation therapy for gastric cancer?
Research shows that Capecitabine, when combined with radiation therapy, is effective in treating gastric cancers, similar to the established use of 5-fluorouracil (5-FU) with radiation. Capecitabine is a convenient oral drug that acts as a radiosensitizer, enhancing the effects of radiation therapy in various gastrointestinal cancers, including gastric cancer.256910
Who Is on the Research Team?
Brian Badgwell, MD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Chemoradiotherapy
Participants receive radiation therapy 5 days a week for 2 weeks and standard of care chemotherapy
Chemotherapy
Participants receive standard of care chemotherapy for up to 2 months
Surgery
Participants undergo standard of care surgery 3-8 weeks post-chemotherapy completion
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Capecitabine
- Fluorouracil
- Radiation Therapy
- Therapeutic Surgical Procedure
Capecitabine is already approved in European Union, United States, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator