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Chemotherapy + Radiotherapy for Esophageal and Gastric Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- My cancer has spread to the lymph nodes in my chest.I have not received any live vaccines in the last 30 days.I am using or willing to use effective birth control after my last treatment dose.I am HIV-positive, on effective treatment, and my viral load is undetectable. My CD4 count is above 200.I have no health issues preventing radiation therapy, as confirmed by a radiation oncologist.I had my last major surgery more than 4 weeks ago.I am of childbearing age and have a negative pregnancy test within the last 14 days.My cancer has spread to no more than 3 places, not counting where it started.I have another cancer, but it won't affect this trial's treatment.My cancer hasn't worsened since my last check-up according to scans.I am fully active or restricted in physically strenuous activity but can do light work.My stomach or esophagus cancer is not HER2 positive and has not worsened after specific chemotherapy treatments.I have never been treated with 5-FU, capecitabine, or oxaliplatin.I do not have any serious illnesses or infections that are not under control.My early stage cancer returned 6 months after completing all treatments.I am not pregnant or breastfeeding.I am fully active or restricted in physically strenuous activity but can do light work.I do not have cancer that has spread to my brain or spinal cord.My cancer is HER2 negative and has spread from my esophagus or stomach.I have no allergies or adverse reactions to 5-FU, capecitabine, or oxaliplatin.
- Group 1: Arm A (FOLXFOX)
- Group 2: Arm B (CAPOX)
- Group 3: Arm C (radiation therapy, FOLFOX)
- Group 4: Arm D (FOLFOX)
- Group 5: Arm E (radiation therapy, CAPOX)
- Group 6: Arm F (CAPOX)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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."
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."
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