Clinical Stage I Esophageal Adenocarcinoma AJCC v8Phase 2PHOXNCT06078709
Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma
A Phase 2 study testing Biospecimen Collection, Computed Tomography and Endoscopic Ultrasound in people with Clinical Stage I Esophageal Adenocarcinoma AJCC v8 and Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8, run by Mayo Clinic at 3 sites in United States.
Trial summary
This phase II trial tests how well preoperative (prior to surgery) radiation therapy with fluorouracil, oxaliplatin, and leucovorin calcium (FOLFOX) works for the treatment of stage I-III esophageal or gastroesophageal junction adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Stage I Esophageal Adenocarcinoma AJCC v8, Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage II Esophageal Adenocarcinoma AJCC v8
- What is being tested?
- Biospecimen Collection, Computed Tomography and Endoscopic Ultrasound
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Nov 2023to 25 May 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Histological confirmation of esophageal or gastroesophageal junction adenocarcinoma, American Joint Committee on Cancer (AJCC) 8th edition stage T1-4N0-3M0
- Candidate for trimodality therapy: neoadjuvant chemo (immuno) therapy, chemoradiation, and esophagectomy
- Surgical consultation has confirmed that patient is an appropriate candidate for esophagectomy
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- Negative pregnancy test done ≤ 7 days prior to chemotherapy, for women of childbearing potential only
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- Ability to provide written informed consent and complete questionnaire(s) by themselves or with assistance
- Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
- Willing to provide blood and tissue samples for correlative research purposes
Who cannot join
- Clinical or biopsy-proven distant metastatic disease (AJCC 8th edition stage TanyNanyM1)
- Cervical or upper esophageal tumor
- Prior chemotherapy or radiotherapy for esophageal cancer or history of radiotherapy to the thorax
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgement of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with proper assessment of adverse events
- Receiving any investigational agent which would be considered as a treatment for the primary neoplasm or other active malignancy ≤ 1 year prior to registration that is considered by the investigator to interfere with the current treatment or measurement of outcomes
- Any of the following:
Show all 9Show fewer
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 2 recruiting
- Active, not recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Christopher L. Hallemeier, MD
- Not yet recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Jonathan B. Ashman, MD, PhD
About this study
Official title: Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal/Gastroesophageal Junction Adenocarcinoma (PHOX)
This phase II trial tests how well preoperative (prior to surgery) radiation therapy with fluorouracil, oxaliplatin, and leucovorin calcium (FOLFOX) works for the treatment of stage I-III esophageal or gastroesophageal junction adenocarcinoma. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Fluorouracil stops cells from making deoxyribonucleic acid (DNA) and it may kill tumor cells. Leucovorin is not a chemotherapy medication but is given in conjunction with chemotherapy. Leucovorin is used with the chemotherapy medication fluorouracil to enhance the effects of the fluorouracil, in other words, to make the drug work better. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill tumor cells. Giving preoperative hypofractionated radiation with fluorouracil and oxaliplatin may kill more tumor cells in patients with stage I-III esophageal or gastroesophageal junction adenocarcinoma.
Read the detailed description
PRIMARY OBJECTIVE:
- To demonstrate non-inferiority of pathologic complete response (pCR) with hypofractionated radiotherapy and concurrent FOLFOX compared to historical controls.
SECONDARY OBJECTIVES:
- Report targeted acute grade ≥ 3 gastrointestinal (GI) toxicity, per Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.
II. Assess post-operative toxicity for patients undergoing esophagectomy, as determined by the Clavien-Dindo Classification.
III. Analyze patient-reported quality of life, per Functional Assessment of Cancer Therapy- Esophageal (FACT-E).
IV. Determine the financial toxicity of hypofractionated radiotherapy, using Comprehensive Score for Financial Toxicity (COST-FACIT).
- Report overall survival and progression-free survival. VI. Report long-term toxicity secondary to trimodality therapy. VII. Report event-free survival. VIII. Assess outcomes for patients treated with hypofractionated radiotherapy and FOLFOX but who did not proceed to esophagectomy.
IX. Compare toxicity of chemoradiation between patients receiving proton based versus (vs.) photon-based radiotherapy.
- Compare clinical outcomes and pCR for patients receiving hypofractioned radiotherapy but different induction chemo (immuno) therapy regimens: no induction vs. fluorouracil, oxaliplatin, leucovorin, docetaxel (FLOT) vs. FLOT + durvalumab.
CORRELATIVE OBJECTIVES:
- Explore the predictive and prognostic role for circulating tumor DNA in esophageal cancer.
II. Study the utility of whole exome and germline sequencing to predict chemoradiation treatment response.
III. Explore the predictive power of whole exome sequencing regarding chemoradiotherapy toxicity.
IV. Implement whole exome and germline sequencing to personalize immunotherapy in esophageal cancer.
- Study the predictive and prognostic role of tumor-derived extracellular vesicles in esophageal cancer.
OUTLINE:
INDUCTION CHEMOTHERAPY: Patients receive 5-FU intravenously (IV) over 24 hours on day 1, leucovorin calcium IV over 10-120 minutes on day 1, oxaliplatin IV over 2-6 hours on day 1, and docetaxel IV over 1 hour on day 1 of each cycle. Treatment repeats every 2 weeks for a total of up to 6 cycles in the absence of disease progression or unacceptable toxicity. Eligible patients also receive durvalumab IV over 1 hour every 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of FLOT, patients undergo radiation therapy daily for 3 weeks with 2 concurrent cycles of FOLFOX.
FOLFOX: Patients receive oxaliplatin IV over 2-6 hours on day 1, leucovorin calcium IV over 10-120 minutes on day 1, and and fluorouracil IV over 46-48 hours on days 1 and 2. of each cycle. Treatment repeats every 2 weeks for a total of 3 cycles in the absence of disease progression or unacceptable toxicity. Starting at cycle 2, patients undergo radiation therapy daily on Monday through Friday for a total of 15 treatments. Patients undergo esophagogastroduodenoscopy (EGD) and/or endoscopic ultrasound (EUS) during screening and undergo computed tomography (CT)/position emission tomography (PET) scan and CT scan as well as blood and tissue sample collection throughout the study.
After completion of study treatment, patients are followed up at 6,12 and 24 months and then up to 5 years.
- Conditions
- Clinical Stage I Esophageal Adenocarcinoma AJCC v8, Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage II Esophageal Adenocarcinoma AJCC v8, Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage III Esophageal Adenocarcinoma AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
- Being tested
- Biospecimen Collection, Computed Tomography, Endoscopic Ultrasound, Esophagogastroduodenoscopy, Fluorouracil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT and PET/CT scan
Endoscopic UltrasoundProcedure or surgery
Also called endosonography, EUS
Undergo EUS
EsophagogastroduodenoscopyProcedure or surgery
Also called EGD, Upper Endoscopy
Undergo EGD
FluorouracilDrug
Also called 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
Given IV
Hypofractionated Radiation TherapyRadiation
Also called Hypofractionated, Hypofractionated Radiotherapy, hypofractionation, Radiation, Hypofractionated
Undergo hypofractionated radiation therapy
Also called Adinepar, Calcifolin, Calcium (6S)-Folinate, Calcium Folinate
Given IV
OxaliplatinDrug
Also called 1-OHP, Ai Heng, Aiheng, Dacotin
Given IV
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET and PET/CT scan
Survey AdministrationOther
Ancillary studies
DocetaxelDrug
Also called 148408-66-6, Docecad, N-Debenzoyl-N-(tert-butoxycarbonyl)-10-deacetyltaxol, RP 56976
Given IV
DurvalumabBiological
Also called Imfinzi, MEDI 4736, MEDI-4736, MEDI4736
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (FLOT and Radiation and FOLFOX) | Experimental | Patients received Induction Chemotherapy [FLOT (5-FU/leucovorin/oxaliplatin/docetaxel)] following by radiation therapy daily for 3 weeks with 2 concurrent cycles of FOLFOX per protocol. See detailed description for more information. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Endoscopic Ultrasound; Procedure: Esophagogastroduodenoscopy; Drug: Fluorouracil; Radiation: Hypofractionated Radiation Therapy; Drug: Leucovorin Calcium; Drug: Oxaliplatin; Procedure: Positron Emission Tomography; Other: Survey Administration; Drug: Docetaxel; Biological: Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response
A single-group design will be used to test whether the proportion is potentially non-inferior, with a non-inferiority proportion (P0) of 0.13 (H0: P ≤ 0.13 versus H1: P > 0.13).
Measured: Up to 5 years after completion of chemoradiation
Secondary outcomes (11)
Incidence of acute ≥ gastrointestinal (GI) adverse events (AEs)
Report acute grade ≥ 3 GI AEs per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 criteria. Will be summarized descriptively.
Measured: Up to 6 weeks after completion of chemoradiation
Incidence of post operative AEs
Determined by the Clavien-Dindo Classification. Will be summarized descriptively.
Measured: From surgery up to 6 months after completion of chemoradiation
Patient-reported quality of life (QOL)
Per Functional Assessment of Cancer Therapy- Esophageal. Will be assessed over time. Wilcoxon signed-rank tests will be used to calculate p-values. Descriptive statistics and graphical methods will also be used to summarize the data.
Measured: Up to 24 months after completion of chemoradiation
Financial toxicity
Financial toxicity will be measured using the COmprehensive Score for financial Toxicity (COST), a patient-reported outcome measure that describes the financial distress experienced by cancer patients. The survey consists of 12 questions, each answered with a 0-4 scale where 0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, and 4=Very much. Results will be reported descriptively and include separate consideration of individual item scores.
Measured: Up to 24 months after completion of chemoradiation
Overall survival (OS)
Will be assessed graphically using the Kaplan-Meier method. Summary statistics will be reported, including medians, 95% confidence intervals, etc.
Measured: From study entry to death from any cause, up to 5 years after completion of chemoradiation
Progression-free survival (PFS)
Will be assessed graphically using the Kaplan-Meier method. Summary statistics will be reported, including medians, 95% confidence intervals, etc.
Measured: From study entry to the first of either disease progression or death, up to 5 years after completion chemoradiation
Long-term toxicity secondary to trimodality therapy
Will be reported descriptively using CTCAE version 5.0 criteria.
Measured: Up to 5 years after completion of chemoradiation
Event free survival
Will be assessed graphically using the Kaplan-Meier method. Summary statistics will be reported, including medians, 95% confidence intervals, etc.
Measured: From study entry to the first of either disease progression or recurrence or relapse or death, up to 5 years after completion of chemoradiation
Outcomes for patients treated with hypofractionated radiotherapy and FOLFOX but who did not proceed to esophagectomy
OS and PFS will be assess using Kaplan-Meier methodology. Summary statistics will be reported, including medians, 95% confidence intervals, etc. AEs and QOL data will be reported with summary statistics and graphical methods, as appropriate.
Measured: Up to 5 years after completion of chemoradiation
Toxicity of chemoradiation between patients receiving proton based versus photon-based radiotherapy
Will be done descriptively, reporting frequencies and percentages between patients.
Measured: Up to 5 years after completion of chemoradiation
Toxicity of chemoradiation between groups receiving proton based versus photon-based radiotherapy
Will be done descriptively, reporting toxicity rates between groups using the chi-square test.
Measured: Up to 5 years after completion of chemoradiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start21 Nov 2023
- Primary completion25 May 2029 (estimated)
- Study completion25 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Stage I Esophageal Adenocarcinoma AJCC v8Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher L. Hallemeier, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078709
- Sponsor's protocol ID
- GMROR2241
- Other IDs
- NCI-2023-07432, GMROR2241, 23-001689
- Acronym
- PHOX
- Status last verified
- Sep 2026
- First submitted
- 3 Oct 2023
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal/Gastroesophageal Junction Adenocarcinoma (PHOX)
- ClinicalTrials.gov ID
- NCT06078709
- Acronym / sponsor ID
- PHOX / GMROR2241
- Conditions
- Clinical Stage I Esophageal Adenocarcinoma AJCC v8, Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage II Esophageal Adenocarcinoma AJCC v8, Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage III Esophageal Adenocarcinoma AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 25 May 2029 (estimated)
- Study completion
- 25 May 2029 (estimated)
- First posted
- 12 Oct 2023 (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 phase II trial tests how well preoperative (prior to surgery) radiation therapy with fluorouracil, oxaliplatin, and leucovorin calcium (FOLFOX) works for the treatment of stage I-III esophageal or gastroesophageal junction adenocarcinoma. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Fluorouracil stops cells from making deoxyribonucleic acid (DNA) and it may kill tumor cells. Leucovorin is not a chemotherapy medication but is given in conjunction with chemotherapy. Leucovorin is used with the chemotherapy medication fluorouracil to enhance the effects of the fluorouracil, in other words, to make the drug work better. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill tumor cells. Giving preoperative hypofractionated radiation with fluorouracil and oxaliplatin may kill more tumor cells in patients with stage I-III esophageal or gastroesophageal junction adenocarcinoma.
Detailed description
PRIMARY OBJECTIVE:
- To demonstrate non-inferiority of pathologic complete response (pCR) with hypofractionated radiotherapy and concurrent FOLFOX compared to historical controls.
SECONDARY OBJECTIVES:
- Report targeted acute grade ≥ 3 gastrointestinal (GI) toxicity, per Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.
II. Assess post-operative toxicity for patients undergoing esophagectomy, as determined by the Clavien-Dindo Classification.
III. Analyze patient-reported quality of life, per Functional Assessment of Cancer Therapy- Esophageal (FACT-E).
IV. Determine the financial toxicity of hypofractionated radiotherapy, using Comprehensive Score for Financial Toxicity (COST-FACIT).
- Report overall survival and progression-free survival. VI. Report long-term toxicity secondary to trimodality therapy. VII. Report event-free survival. VIII. Assess outcomes for patients treated with hypofractionated radiotherapy and FOLFOX but who did not proceed to esophagectomy.
IX. Compare toxicity of chemoradiation between patients receiving proton based versus (vs.) photon-based radiotherapy.
- Compare clinical outcomes and pCR for patients receiving hypofractioned radiotherapy but different induction chemo (immuno) therapy regimens: no induction vs. fluorouracil, oxaliplatin, leucovorin, docetaxel (FLOT) vs. FLOT + durvalumab.
CORRELATIVE OBJECTIVES:
- Explore the predictive and prognostic role for circulating tumor DNA in esophageal cancer.
II. Study the utility of whole exome and germline sequencing to predict chemoradiation treatment response.
III. Explore the predictive power of whole exome sequencing regarding chemoradiotherapy toxicity.
IV. Implement whole exome and germline sequencing to personalize immunotherapy in esophageal cancer.
- Study the predictive and prognostic role of tumor-derived extracellular vesicles in esophageal cancer.
OUTLINE:
INDUCTION CHEMOTHERAPY: Patients receive 5-FU intravenously (IV) over 24 hours on day 1, leucovorin calcium IV over 10-120 minutes on day 1, oxaliplatin IV over 2-6 hours on day 1, and docetaxel IV over 1 hour on day 1 of each cycle. Treatment repeats every 2 weeks for a total of up to 6 cycles in the absence of disease progression or unacceptable toxicity. Eligible patients also receive durvalumab IV over 1 hour every 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of FLOT, patients undergo radiation therapy daily for 3 weeks with 2 concurrent cycles of FOLFOX.
FOLFOX: Patients receive oxaliplatin IV over 2-6 hours on day 1, leucovorin calcium IV over 10-120 minutes on day 1, and and fluorouracil IV over 46-48 hours on days 1 and 2. of each cycle. Treatment repeats every 2 weeks for a total of 3 cycles in the absence of disease progression or unacceptable toxicity. Starting at cycle 2, patients undergo radiation therapy daily on Monday through Friday for a total of 15 treatments. Patients undergo esophagogastroduodenoscopy (EGD) and/or endoscopic ultrasound (EUS) during screening and undergo computed tomography (CT)/position emission tomography (PET) scan and CT scan as well as blood and tissue sample collection throughout the study.
After completion of study treatment, patients are followed up at 6,12 and 24 months and then up to 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (FLOT and Radiation and FOLFOX) | Experimental | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Procedure: Endoscopic Ultrasound, Procedure: Esophagogastroduodenoscopy, Drug: Fluorouracil, Radiation: Hypofractionated Radiation Therapy, Drug: Leucovorin Calcium, Drug: Oxaliplatin, Procedure: Positron Emission Tomography, Other: Survey Administration, Drug: Docetaxel, Biological: DurvalumabPatients received Induction Chemotherapy [FLOT (5-FU/leucovorin/oxaliplatin/docetaxel)] following by radiation therapy daily for 3 weeks with 2 concurrent cycles of FOLFOX per protocol. See detailed description for more information. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years
- Histological confirmation of esophageal or gastroesophageal junction adenocarcinoma, American Joint Committee on Cancer (AJCC) 8th edition stage T1-4N0-3M0
- Candidate for trimodality therapy: neoadjuvant chemo (immuno) therapy, chemoradiation, and esophagectomy
- Surgical consultation has confirmed that patient is an appropriate candidate for esophagectomy
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Key exclusion criteria (9 listed)
- Clinical or biopsy-proven distant metastatic disease (AJCC 8th edition stage TanyNanyM1)
- Cervical or upper esophageal tumor
- Prior chemotherapy or radiotherapy for esophageal cancer or history of radiotherapy to the thorax
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgement of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with proper assessment of adverse events
- Receiving any investigational agent which would be considered as a treatment for the primary neoplasm or other active malignancy ≤ 1 year prior to registration that is considered by the investigator to interfere with the current treatment or measurement of outcomes
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 |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Treatment (FLOT and Radiation and FOLFOX) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT and PET/CT scan | Procedure or surgery | Treatment (FLOT and Radiation and FOLFOX) |
| Endoscopic UltrasoundAlso: endosonography, EUSUndergo EUS | Procedure or surgery | Treatment (FLOT and Radiation and FOLFOX) |
| EsophagogastroduodenoscopyAlso: EGD, Upper EndoscopyUndergo EGD | Procedure or surgery | Treatment (FLOT and Radiation and FOLFOX) |
| FluorouracilAlso: 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedioneGiven IV | Drug | Treatment (FLOT and Radiation and FOLFOX) |
| Hypofractionated Radiation TherapyAlso: Hypofractionated, Hypofractionated Radiotherapy, hypofractionation, Radiation, HypofractionatedUndergo hypofractionated radiation therapy | Radiation | Treatment (FLOT and Radiation and FOLFOX) |
| Leucovorin CalciumAlso: Adinepar, Calcifolin, Calcium (6S)-Folinate, Calcium FolinateGiven IV | Drug | Treatment (FLOT and Radiation and FOLFOX) |
| OxaliplatinAlso: 1-OHP, Ai Heng, Aiheng, DacotinGiven IV | Drug | Treatment (FLOT and Radiation and FOLFOX) |
| Positron Emission TomographyAlso: Medical Imaging, PET, PET Scan, Positron emission tomography (procedure)Undergo PET and PET/CT scan | Procedure or surgery | Treatment (FLOT and Radiation and FOLFOX) |
| Survey AdministrationAncillary studies | Other | Treatment (FLOT and Radiation and FOLFOX) |
| DocetaxelAlso: 148408-66-6, Docecad, N-Debenzoyl-N-(tert-butoxycarbonyl)-10-deacetyltaxol, RP 56976Given IV | Drug | Treatment (FLOT and Radiation and FOLFOX) |
| DurvalumabAlso: Imfinzi, MEDI 4736, MEDI-4736, MEDI4736Given IV | Biological | Treatment (FLOT and Radiation and FOLFOX) |
Primary outcome
Pathologic complete response
Time frame: Up to 5 years after completion of chemoradiation
A single-group design will be used to test whether the proportion is potentially non-inferior, with a non-inferiority proportion (P0) of 0.13 (H0: P ≤ 0.13 versus H1: P > 0.13).
11 secondary outcomes
Incidence of acute ≥ gastrointestinal (GI) adverse events (AEs)
Time frame: Up to 6 weeks after completion of chemoradiation
Incidence of post operative AEs
Time frame: From surgery up to 6 months after completion of chemoradiation
Patient-reported quality of life (QOL)
Time frame: Up to 24 months after completion of chemoradiation
Financial toxicity
Time frame: Up to 24 months after completion of chemoradiation
Overall survival (OS)
Time frame: From study entry to death from any cause, up to 5 years after completion of chemoradiation
Progression-free survival (PFS)
Time frame: From study entry to the first of either disease progression or death, up to 5 years after completion chemoradiation
Long-term toxicity secondary to trimodality therapy
Time frame: Up to 5 years after completion of chemoradiation
Event free survival
Time frame: From study entry to the first of either disease progression or recurrence or relapse or death, up to 5 years after completion of chemoradiation
Outcomes for patients treated with hypofractionated radiotherapy and FOLFOX but who did not proceed to esophagectomy
Time frame: Up to 5 years after completion of chemoradiation
Toxicity of chemoradiation between patients receiving proton based versus photon-based radiotherapy
Time frame: Up to 5 years after completion of chemoradiation
Toxicity of chemoradiation between groups receiving proton based versus photon-based radiotherapy
Time frame: Up to 5 years after completion of chemoradiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Christopher L. Hallemeier, MD principal investigator
Mayo Clinic in Rochester
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biospecimen Collection, Computed Tomography and Endoscopic Ultrasound in people with Clinical Stage I Esophageal Adenocarcinoma AJCC v8 and Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8, run by Mayo Clinic at 3 sites 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 9 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic complete response (time frame: Up to 5 years after completion of chemoradiation). 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 1 Oct 2026.