Study on Induction FLOT with CROSS Chemoradiotherapy for Esophageal Cancer
Sponsor: University of Colorado, Denver
ClinicalTrials ID:NCT04028167
This clinical trial is testing a new treatment plan that combines chemotherapy and radiation therapy before surgery to see if it can better control esophageal and gastroesophageal cancer. The study aims to improve outcomes for patients with these types of cancer.
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Program Overview
The study is exploring a new treatment approach for esophageal and gastroesophageal cancer. It involves using a combination of chemotherapy drugs (docetaxel, oxaliplatin, leucovorin, and 5-FU) before adding chemoradiotherapy with carboplatin and paclitaxel. This is done before surgery to remove the cancer. The goal is to see if this combination can improve the chances of completely eliminating the cancer and prevent it from coming back.
Description
Current treatments for esophageal and gastroesophageal cancer often don't fully eliminate the cancer, and many patients experience the cancer returning. This study is testing a new approach that combines different chemotherapy drugs with radiation therapy before surgery. The hope is that this combination will be more effective in shrinking the cancer and preventing it from coming back.
The study will compare this new treatment plan to existing methods to see if it offers better results. Patients with certain types of esophageal cancer will receive the new treatment before undergoing surgery to remove the cancer. Researchers will monitor how well the cancer responds to the treatment and whether it helps prevent the cancer from returning.
The study is open to patients with specific types of esophageal cancer who have not yet received treatment. Participants will need to meet certain health criteria and agree to follow the study procedures, including regular check-ups and tests to monitor their health and the treatment's effectiveness.
Eligibility Criteria
Inclusion Criteria
- Must be willing to sign a consent form and follow study procedures.
- Men and women aged 18 to 100.
- Have a newly diagnosed, operable esophageal or gastroesophageal cancer that has not spread to other parts of the body.
- Cancer must be confirmed by scans and tests, and diagnosed within 3 months before joining the study.
- Must not have received any prior chemotherapy or radiation therapy for this cancer.
- Must be eligible for a treatment plan that includes chemotherapy, radiation, and surgery.
- Must be in good general health with a performance status score of 0 or 1.
- Must have adequate blood cell counts and liver and kidney function.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 3 months after the last chemotherapy dose.
- Men must agree to use birth control and avoid donating sperm during the study and for 3 months after the last chemotherapy dose.
Exclusion Criteria
- Cancer that has spread or cannot be surgically removed.
- Different types of esophageal cancer, such as squamous cell carcinoma.
- Previous treatment with chemotherapy or radiation for this cancer.
- Other active cancers within the last 3 years that could interfere with treatment.
- Previous radiation therapy that overlaps with planned treatment areas.
- Certain autoimmune diseases.
- Severe nerve damage or other serious medical conditions.
- Active hepatitis B or C infections.
- Unstable heart conditions.
- Allergies to study drugs.
- Pregnant or breastfeeding women.
- Prisoners or those unable to consent to the study.
- Known deficiency in a specific enzyme (DPD) that affects drug metabolism.
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