Study Comparing Standard Treatment With and Without Additional Procedures for Patients With Metastatic Upper GI Cancer and No Detectable Tumor DNA in Blood
Sponsor: Yale University
ClinicalTrials ID:NCT07282912
This clinical trial is exploring whether adding specific procedures to the standard treatment can improve outcomes for patients with certain types of metastatic upper gastrointestinal cancers who have no detectable tumor DNA in their blood after initial chemotherapy.
Patient Parameters
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Program Overview
This study is testing if adding extra procedures, like surgery or radiation, to the usual treatment can help patients with certain metastatic upper gastrointestinal cancers. These patients have no detectable tumor DNA in their blood after three months of initial chemotherapy. The main goal is to see if these additional procedures can help patients live longer without the cancer getting worse, compared to those who only receive the standard treatment.
Description
Patients with certain types of metastatic upper gastrointestinal cancers, such as those affecting the esophagus, stomach, liver, and pancreas, may benefit from additional procedures like surgery or radiation. This study is investigating whether these procedures, when added to standard treatment, can help patients live longer without their cancer progressing. The study focuses on patients who have no detectable tumor DNA in their blood after initial chemotherapy, as this may indicate a better response to additional treatments. Participants will be randomly assigned to receive either the standard treatment alone or with the added procedures, and their progress will be monitored to assess the effectiveness of these approaches.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with stage IV cancer of the esophagus, stomach, pancreas, bile ducts, gallbladder, or related areas.
- The primary tumor must be treatable with surgery or other definitive treatments.
- Limited metastatic disease that can be completely treated with surgery or other interventions.
- No detectable tumor DNA in blood after initial chemotherapy.
- Adequate organ function and blood counts.
- Aged 18 to 80 years old.
- Good overall health with a performance status score of 0 or 1.
- Willing to use contraception during and after the study.
- Able to provide informed consent.
Exclusion Criteria
- Positive pregnancy test or pregnant.
- Low oxygen levels or need for supplemental oxygen.
- Cancer that is worsening despite current treatment.
- Another active cancer requiring treatment in the past three years.
- Cancer spread to the brain or bones.
- Significant heart disease or uncontrolled high blood pressure.
- Severe liver problems.
- Mental health or substance abuse issues affecting study participation.
- Unable to swallow medication or have digestive issues affecting absorption.
- Active infection or immunodeficiency.
- Pregnant, breastfeeding, or planning to conceive during the study.
- Unable to receive necessary treatments due to medical or insurance reasons.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Smilow Cancer Center | 06519 | New Haven | Connecticut |
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