WITHDRAWN

Circulating Tumor DNA (ctDNA) in Locally Advanced Esophageal and Gastroesophageal (GE) Junction Adenocarcinoma

Conditions

Adenocarcinoma Esophagus Adenocarcinoma Esophagus Gastroesophageal Junction Chemotherapy Chemoradiation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is an observational study to determine the feasibility of assessing tumor response utilizing ctDNA in patients of locally advanced esophageal and gastroesophageal junction (LA-EA/GEJ) cancer undergoing total neoadjuvant therapy (TNT) consisting of systemic chemotherapy (modified FOLFOX or FLOT/DFOX) followed by concurrent chemoradiation \[50.4 Gray (Gy) over approximately six weeks with concurrent radio sensitizing dose of carboplatin/paclitaxel\].

Official Title

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

Quick Facts

Study Start:2022-05-13

Study Completion:2025-05-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:WITHDRAWN

Study ID

NCT05067842

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Principal Investigator

Ben George, MD

PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Study Locations (Sites)

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Medical College of Wisconsin

Ben George, MD, PRINCIPAL_INVESTIGATOR, Medical College of Wisconsin

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-13

Study Completion Date2025-05-30

Study Record Updates

Study Start Date2022-05-13

Study Completion Date2025-05-30

Terms related to this study

Keywords Provided by Researchers

Adenocarcinoma
Esophagus
Gastroesophageal Junction
Chemotherapy
Chemoradiation

Additional Relevant MeSH Terms

Adenocarcinoma Esophagus