Assessing tumor response in advanced esophageal cancer using blood tests

A Pilot Observational Study to Assess Feasibility of Tumor Response Assessment by Circulating Tumor DNA (ctDNA) in Patients With Locally Advanced Esophageal and GE Junction Adenocarcinoma Undergoing Treatment With Total Upfront Chemotherapy and Chemoradiation

This study is testing if blood tests can help track how well treatment is working for people with advanced esophageal cancer who are starting a new therapy.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Medical College of Wisconsin (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Milwaukee, Wisconsin)
• Trial ID: NCT05067842 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the feasibility of using circulating tumor DNA (ctDNA) to assess tumor response in patients with locally advanced esophageal and gastroesophageal junction adenocarcinoma undergoing total neoadjuvant therapy. Participants will receive systemic chemotherapy followed by chemoradiation, and their tumor response will be monitored through blood samples and PET scans. The study will enroll newly diagnosed patients who have not received prior chemotherapy or radiation therapy and will assess their eligibility based on specific clinical criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with newly diagnosed, untreated, locally advanced adenocarcinoma of the esophagus or gastroesophageal junction.

Not a fit: Patients with prior chemotherapy or radiation therapy for their condition will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a less invasive method for monitoring treatment response in patients with advanced esophageal cancer.

How similar studies have performed: While the use of ctDNA in cancer monitoring is gaining traction, this specific approach in locally advanced esophageal cancer is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Ability to understand a written informed consent document, and the willingness to sign and date it.
2. Stated willingness to comply with all study procedures and be available for the duration of the study.
3. Male or female between the ages of 18 and 80 years.
4. Newly diagnosed, clinically advanced T3-T4 or node-positive adenocarcinoma of esophagus or gastroesophageal junction as assessed by PET/CT or CT of the chest, abdomen and pelvis and/or by endoscopic ultrasound, with pathologic diagnosis obtained within one month of signing consent, without delivery of prior chemotherapy or radiation therapy.
5. Subjects must be previously untreated with systemic chemotherapy or radiation therapy.
6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
7. Adequate bone marrow function: white blood cell (WBC) count \> 3 x 10\^9/L; hemoglobin \> 8 g/dL; platelets \> 100 x 10\^9/L.
8. Adequate liver function: total bilirubin \< 1.5 x upper limit of normal; aspartate aminotransferase (AST) \< 3 x upper limit of normal (ULN); alanine aminotransferase (ALT) \< 3 x upper limit of normal); serum creatinine \< 1.5 x ULN.
9. Women and men of childbearing age should use contraceptives throughout the treatment period of the study.
10. Ability to obtain tissue sample for ctDNA analysis and detectable baseline ctDNA level.
11. Concurrent participation in other clinical studies that will not affect the general sequence of therapies in the trial schema of this study would be allowed.
12. Adjuvant chemotherapy or immunotherapy would be allowed as this is an observational study and would be at clinician's discretion.

Exclusion Criteria:

1. Subjects with metastatic gastric or gastroesophageal junction adenocarcinoma.
2. Subjects with esophageal or gastroesophageal junction squamous cell carcinoma or adeno-squamous carcinoma.
3. Prior treatment with chemotherapy or radiation therapy for gastric or gastroesophageal adenocarcinoma.
4. Subjects that received treatment for a second primary malignancy within one year of screening will be excluded, however pts. with h/o early-stage cancers treated with curative intent, including basal or squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the prostate, cervix or breast would be eligible.
5. Subjects with greater than grade 2 peripheral neuropathy.
6. Any serious or uncontrolled medical disorder or active infection, which in the opinion of the investigator may increase the risk associated with study participation, study treatment administration, or would impair the ability of the subject to receive study treatment.
7. Known history of active hepatitis B or hepatitis C.
8. Clinically unstable cardiac disease, including unstable angina, congestive heart failure, ventricular arrhythmia.
9. History of allergy or hypersensitivity to any of the study drugs or study drug components.
10. Contraindications to any of the study drugs of the chemotherapy regimens selected by the investigator.
11. Known history of dihydropyridine dehydrogenase (DPD) deficiency.
12. Female patients who are pregnant, nursing or lactating.

Where this trial is running

Milwaukee, Wisconsin

• Froedtert Hospital and the Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)

Study contacts

• Principal investigator: Ben George, MD — Medical College of Wisconsin
• Study coordinator: Medical College of Wisconsin Cancer Center Clinical Trials Office

Conditions Adenocarcinoma Esophagus; Adenocarcinoma; Esophagus; Gastroesophageal Junction; Chemotherapy; Chemoradiation