Study on Preoperative Radiation and Chemotherapy for Esophageal or Gastroesophageal Junction Cancer
Sponsor: Mayo Clinic
ClinicalTrials ID:NCT06078709
This clinical trial is testing whether a combination of radiation therapy and chemotherapy given before surgery can effectively treat stage I-III esophageal or gastroesophageal junction cancer. The study aims to see if this approach can kill more cancer cells with fewer side effects.
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Program Overview
This study is exploring a treatment for stage I-III esophageal or gastroesophageal junction cancer that involves giving radiation therapy and chemotherapy before surgery. The radiation therapy is delivered in higher doses over a shorter period, which may kill more cancer cells and cause fewer side effects. The chemotherapy drugs used are fluorouracil, oxaliplatin, and leucovorin. Fluorouracil helps stop cancer cells from making DNA, while leucovorin enhances its effects. Oxaliplatin damages the DNA of cancer cells, potentially killing them. The goal is to see if this combination can effectively reduce cancer cells before surgery.
Description
The main goal of this study is to show that the combination of hypofractionated radiotherapy and FOLFOX chemotherapy is not worse than previous treatments in achieving a complete response in cancer tissue. Researchers will also look at the side effects of the treatment, how it affects patients' quality of life, and the financial impact of the treatment. They will track overall survival, progression-free survival, and any long-term side effects. The study will also compare the side effects of different types of radiation therapy and explore the role of genetic testing in predicting treatment outcomes.
Participants will receive oxaliplatin through an IV for 2-6 hours on the first day, leucovorin calcium through an IV for 10-120 minutes on the first day, and fluorouracil through an IV over 46-48 hours on the first and second days. This treatment cycle repeats every two weeks for a total of three cycles, as long as the disease does not progress or cause unacceptable side effects. Starting with the second cycle, participants will receive radiation therapy every weekday for a total of 15 treatments. Throughout the study, participants will undergo various tests, including endoscopies, CT/PET scans, and blood and tissue sample collections.
After completing the study treatment, participants will have follow-up visits at 6, 12, and 24 months, and then annually for up to 5 years.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of esophageal or gastroesophageal junction adenocarcinoma, stage I-III.
- Be a candidate for a combination of chemotherapy, radiation, and surgery.
- Have been evaluated by a surgeon and deemed suitable for surgery.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Women of childbearing potential must have a negative pregnancy test within 7 days before starting chemotherapy.
- Be able to provide written informed consent and complete questionnaires independently or with help.
- Be willing to return to the study site for follow-up visits.
- Be willing to provide blood and tissue samples for research purposes.
Exclusion Criteria
- Have cancer that has spread to distant parts of the body.
- Have a tumor located in the cervical or upper esophagus.
- Have received prior chemotherapy or radiation for esophageal cancer or radiation to the chest area.
- Have other serious health conditions that would make participation unsafe or interfere with the study.
- Be taking any investigational drugs for cancer or have another active cancer within the past year that could interfere with the study.
- Be pregnant or breastfeeding.
- Be of childbearing potential and unwilling to use effective contraception.
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