Adenocarcinoma EsophagusTRACT DNANCT05067842
Circulating Tumor DNA (ctDNA) in Locally Advanced Esophageal and Gastroesophageal (GE) Junction Adenocarcinoma
An observational study of Adenocarcinoma Esophagus, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Adenocarcinoma Esophagus
- What is being tested?
- Circulating tumor DNA(ctDNA) level measurement
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2022to 30 May 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will enroll male and female subjects with diagnosed esophageal or gastroesophageal adenocarcinoma between the ages of 18 and 80 years of age.
Who may be able to join
- Ability to understand a written informed consent document, and the willingness to sign and date it.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- Male or female between the ages of 18 and 80 years.
- 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.
- Subjects must be previously untreated with systemic chemotherapy or radiation therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
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- Adequate bone marrow function: white blood cell (WBC) count > 3 x 10^9/L; hemoglobin > 8 g/dL; platelets > 100 x 10^9/L.
- 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.
- Women and men of childbearing age should use contraceptives throughout the treatment period of the study.
- Ability to obtain tissue sample for ctDNA analysis and detectable baseline ctDNA level.
- 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.
- Adjuvant chemotherapy or immunotherapy would be allowed as this is an observational study and would be at clinician's discretion.
Who cannot join
- Subjects with metastatic gastric or gastroesophageal junction adenocarcinoma.
- Subjects with esophageal or gastroesophageal junction squamous cell carcinoma or adeno-squamous carcinoma.
- Prior treatment with chemotherapy or radiation therapy for gastric or gastroesophageal adenocarcinoma.
- 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.
- Subjects with greater than grade 2 peripheral neuropathy.
- 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.
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- Known history of active hepatitis B or hepatitis C.
- Clinically unstable cardiac disease, including unstable angina, congestive heart failure, ventricular arrhythmia.
- History of allergy or hypersensitivity to any of the study drugs or study drug components.
- Contraindications to any of the study drugs of the chemotherapy regimens selected by the investigator.
- Known history of dihydropyridine dehydrogenase (DPD) deficiency.
- Female patients who are pregnant, nursing or lactating.
Trial locations and contacts
1 site in 1 country.
United States1 site
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
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
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].
Read the detailed description
This study will explore the feasibility of assessing tumor response utilizing ctDNA in patients of Locally Advanced Esophageal and Gastroesophageal Junction Adenocarcinoma (LA-EA/GEJ) undergoing TNT consisting of systemic chemotherapy (modified FOLFOX or FLOT/DFOX) followed by concurrent chemoradiation (50.4 Gy over approximately six weeks with concurrent radio sensitizing dose of carboplatin/paclitaxel). The study schema in the following section illustrates the study design. In this observational study, patients with LA -EA/GEJ ca who are selected for the standard-of-care TNT will be enrolled. After obtaining informed consent, a venous blood sample and the archival tissue block from the initial diagnostic tumor biopsy will be sent to the Natera Inc. Patients that have an excellent response (defined by >35% reduction in standardized uptake value (SUV) max on PET scan) from four cycles of standard-of-care induction chemotherapy (FOLFOX, DFOX or FLOT) will be treated with four additional cycles of therapy followed by chemoradiation and then assessed for curative intent surgery.
Patients who receive four cycles of neoadjuvant chemotherapy and don't have an excellent clinical response on the PET scan will not receive additional induction chemotherapy. They will be started on chemoradiation (50.4 Gy, radiation dose at radiation oncologists discretion with concurrent weekly carboplatin and paclitaxel) followed by assessment for surgery. Dose adjustment of radiation and chemotherapy will be allowed as per standard of care. Additional blood samples will be obtained for subsequent ctDNA measurements (after four cycles of neoadjuvant chemotherapy within +/- five days of the imaging study; after eight cycles for PET responders only; after the completion of chemoradiation around one to 14 days before surgery and 10 to 14 days after surgery). All patients may also choose to undergo additional serial ctDNA level measurements for surveillance after the surgery every three months for two years (optional).
Tumor response rate assessed by ctDNA will be compared with the response rate assessed by standard methods (PET scan, endoscopic ultrasound or CT/MRI) at different time points to explore if a significant correlation exists between these two response assessment methods. Imaging studies will also be discussed in the tumor board. If preliminary data support the hypothesis that peripheral blood ctDNA can be utilized for tumor response assessment in this scenario, a larger study will be conducted to validate this method. Once validated, ctDNA measurement can potentially supplement other expensive, uncomfortable, and time-consuming methods of tumor response assessment, such as endoscopic ultrasound and PET/CT.
This study does not involve any investigational therapeutic intervention. The only intervention planned in this study is obtaining multiple peripheral venous blood samples at prespecified time points described above for ctDNA level measurements.
- Conditions
- Adenocarcinoma Esophagus
- Being tested
- Circulating tumor DNA(ctDNA) level measurement
- Keywords
- Adenocarcinoma, Esophagus, Gastroesophageal Junction, Chemotherapy, Chemoradiation
- Medical subject headings
- Adenocarcinoma Of Esophagus, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circulating tumor DNA(ctDNA) level measurementDiagnostic test
The ctDNA level will be measured using the Signatera platform developed by Natera, Inc. Signatera is a patient-specific, tumor informed custom-built ctDNA monitoring assay.
| Study group | Role | What they receive |
|---|---|---|
| Locally advanced esophageal or gastroesophageal adenocarcinoma | Subjects with diagnosed locally advanced esophageal or gastroesophageal adenocarcinoma. Receives: Diagnostic Test: Circulating tumor DNA(ctDNA) level measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response measured by circulating tumor DNA
This measure will quantify ctDNA concentration expressed in mean tumor molecules (MTM)/ml. Measurements will be made at Baseline, 8 weeks, 16 weeks, 14 days before surgery (approximately 8 months), 14 days after surgery, and every three months in follow-up up to 2 years. Results will be reported at Baseline, 14 days prior to surgery (approximately 8 months), 1 year, and 2 years.
Measured: Baseline, 14 days prior to surgery (approximately 8 months), 1 year, and 2 years
Secondary outcomes (3)
R0 Surgical Resection
This measure is the number of subjects with R0 (negative margin) surgical resection of tumor.
Measured: 2 weeks post surgery
Overall Survival
this measure is the number of subjects alive at 1 year and 2 years.
Measured: 1 year, 2 years
Recurrence-Free Survival
This measure is the number of subjects without evidence of recurrent tumor at at 1 year.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start13 May 2022
- Primary completion30 May 2025
- Study completion30 May 2025
Why it stopped: Low accrual and PI leaving institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma EsophagusStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben George, Medical College of Wisconsin
- Investigators
- Ben George, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067842
- Sponsor's protocol ID
- PRO00041977
- Acronym
- TRACT DNA
- Status last verified
- Jun 2025
- First submitted
- 24 Sep 2021
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05067842
- Acronym / sponsor ID
- TRACT DNA / PRO00041977
- Conditions
- Adenocarcinoma Esophagus
- Keywords
- Adenocarcinoma, Esophagus, Gastroesophageal Junction, Chemotherapy, Chemoradiation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Low accrual and PI leaving institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 13 May 2022 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 5 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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].
Detailed description
This study will explore the feasibility of assessing tumor response utilizing ctDNA in patients of Locally Advanced Esophageal and Gastroesophageal Junction Adenocarcinoma (LA-EA/GEJ) undergoing TNT consisting of systemic chemotherapy (modified FOLFOX or FLOT/DFOX) followed by concurrent chemoradiation (50.4 Gy over approximately six weeks with concurrent radio sensitizing dose of carboplatin/paclitaxel). The study schema in the following section illustrates the study design. In this observational study, patients with LA -EA/GEJ ca who are selected for the standard-of-care TNT will be enrolled. After obtaining informed consent, a venous blood sample and the archival tissue block from the initial diagnostic tumor biopsy will be sent to the Natera Inc. Patients that have an excellent response (defined by >35% reduction in standardized uptake value (SUV) max on PET scan) from four cycles of standard-of-care induction chemotherapy (FOLFOX, DFOX or FLOT) will be treated with four additional cycles of therapy followed by chemoradiation and then assessed for curative intent surgery.
Patients who receive four cycles of neoadjuvant chemotherapy and don't have an excellent clinical response on the PET scan will not receive additional induction chemotherapy. They will be started on chemoradiation (50.4 Gy, radiation dose at radiation oncologists discretion with concurrent weekly carboplatin and paclitaxel) followed by assessment for surgery. Dose adjustment of radiation and chemotherapy will be allowed as per standard of care. Additional blood samples will be obtained for subsequent ctDNA measurements (after four cycles of neoadjuvant chemotherapy within +/- five days of the imaging study; after eight cycles for PET responders only; after the completion of chemoradiation around one to 14 days before surgery and 10 to 14 days after surgery). All patients may also choose to undergo additional serial ctDNA level measurements for surveillance after the surgery every three months for two years (optional).
Tumor response rate assessed by ctDNA will be compared with the response rate assessed by standard methods (PET scan, endoscopic ultrasound or CT/MRI) at different time points to explore if a significant correlation exists between these two response assessment methods. Imaging studies will also be discussed in the tumor board. If preliminary data support the hypothesis that peripheral blood ctDNA can be utilized for tumor response assessment in this scenario, a larger study will be conducted to validate this method. Once validated, ctDNA measurement can potentially supplement other expensive, uncomfortable, and time-consuming methods of tumor response assessment, such as endoscopic ultrasound and PET/CT.
This study does not involve any investigational therapeutic intervention. The only intervention planned in this study is obtaining multiple peripheral venous blood samples at prespecified time points described above for ctDNA level measurements.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Locally advanced esophageal or gastroesophageal adenocarcinoma | – | Diagnostic Test: Circulating tumor DNA(ctDNA) level measurementSubjects with diagnosed locally advanced esophageal or gastroesophageal adenocarcinoma. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll male and female subjects with diagnosed esophageal or gastroesophageal adenocarcinoma between the ages of 18 and 80 years of age.
Key inclusion criteria (12 listed)
- Ability to understand a written informed consent document, and the willingness to sign and date it.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- Male or female between the ages of 18 and 80 years.
- 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.
- Subjects must be previously untreated with systemic chemotherapy or radiation therapy.
Key exclusion criteria (12 listed)
- Subjects with metastatic gastric or gastroesophageal junction adenocarcinoma.
- Subjects with esophageal or gastroesophageal junction squamous cell carcinoma or adeno-squamous carcinoma.
- Prior treatment with chemotherapy or radiation therapy for gastric or gastroesophageal adenocarcinoma.
- 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.
- Subjects with greater than grade 2 peripheral neuropathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circulating tumor DNA(ctDNA) level measurementThe ctDNA level will be measured using the Signatera platform developed by Natera, Inc. Signatera is a patient-specific, tumor informed custom-built ctDNA monitoring assay. | Diagnostic test | Locally advanced esophageal or gastroesophageal adenocarcinoma |
Primary outcome
Tumor response measured by circulating tumor DNA
Time frame: Baseline, 14 days prior to surgery (approximately 8 months), 1 year, and 2 years
This measure will quantify ctDNA concentration expressed in mean tumor molecules (MTM)/ml. Measurements will be made at Baseline, 8 weeks, 16 weeks, 14 days before surgery (approximately 8 months), 14 days after surgery, and every three months in follow-up up to 2 years. Results will be reported at Baseline, 14 days prior to surgery (approximately 8 months), 1 year, and 2 years.
3 secondary outcomes
R0 Surgical Resection
Time frame: 2 weeks post surgery
Overall Survival
Time frame: 1 year, 2 years
Recurrence-Free Survival
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben George, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenocarcinoma Esophagus, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor response measured by circulating tumor DNA (time frame: Baseline, 14 days prior to surgery (approximately 8 months), 1 year, and 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.