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Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma

Study acronym: PHOX
StatusRecruiting
PhasePhase 2
Started2023-11-21
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 23 months later May 30, 2027 → May 25, 2029
See other at-risk trials from Mayo Clinic

Amendment history

2026-10-02
Primary completion pushed: 2027-05-30 → 2029-05-25
Completion pushed: 2027-05-30 → 2029-05-25
2026-04-17
Study Status v11
Primary completion moved earlier: 2031-05-30 → 2027-05-30
Completion moved earlier: 2031-05-30 → 2027-05-30
2026-02-24
Study Status v10
Primary completion date2026-05-30→2031-05-30
Completion date2026-11-30→2031-05-30
2025-09-24
Study Status, Study Description, Arms and Interventions, Eligibility v9
InterventionsBiospecimen Collection (Procedure), Computed Tomography (Procedure), Docetaxel (Drug), Endoscopic Ultrasound (Procedure)…→Biospecimen Collection (Procedure), Computed Tomography (Procedure), Docetaxel (Drug), Durvalumab (Biological), Endoscopic Ultrasound…
Eligibility criteria+10 characters
[...] e T1-4N0-3M0 Candidate for trimodality therapy: neoadjuvant chemotherapychemo (immuno) therapy, chemoradiation, and esophagectomy Surgical consultation ha [...]
Study description+329 characters
[...] eiving proton based versus (vs.) photon-based radiotherapy. X. 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: I. Explore the predictive and progno [...] sicles in esophageal cancer. OUTLINE: INDUCTION CHEMOTHERAPY (FLOT [5-FU/leucovorin/oxaliplatin/docetaxel]): Patients receive 5-FU intravenously (IV) over 24 hours on [...] cycle. Treatment repeats every 2 weeks for a total of up to 46 cycles in [...] [...]
2025-04-02
Study Identification, Study Status, Conditions, Contacts/Locations v8
Study sitesdetails revised at 3 of 3 sites
Study titlerevised
Preoperative Hypofractionated Radiotherapy withWith FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma
Show 7 earlier versions
2024-09-30
Study Identification, Study Status, Study Description, Conditions, Arms and Interventions, Contacts/Locations v7
InterventionsBiospecimen Collection (Procedure), Computed Tomography (Procedure), Endoscopic Ultrasound (Procedure), Esophagogastroduodenoscopy…→Biospecimen Collection (Procedure), Computed Tomography (Procedure), Docetaxel (Drug), Endoscopic Ultrasound (Procedure)…
Study description+538 characters
[...] ared to historical controls. SECONDARY OBJECTIVES: I. Report targeted acute grade ≥ 3 gastrointestinal (GI) toxicity, per Common [...] rived extracellular vesicles in esophageal cancer. OUTLINE: INDUCTION CHEMOTHERAPY (FLOT [5-FU/leucovorin/oxaliplatin/docetaxel]): 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 e [...] Patients receive oxaliplatin intravenously (IV) over 2-6 hours on day 1, leucovorin calcium IV over 10-120 [...] , an [...]
Study sitescontacts updated at 3 of 3 sites
Study titlerevised
Preoperative Hypofractionated Radiotherapy Withwith FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma
2024-07-02
Study Status, Study Description, Arms and Interventions v6
Study description+11 characters
[...] emission tomography (PET) scan and CT scan as well as blood and tissue sample collection throughout the study. After completion of [...]
2024-06-25
Study Status, Eligibility v5
Eligibility criteria+11 characters
[...] tive monitoring phase of the study) Willing to provide blood and tissue samples for correlative research purposes Exclusion Criteri [...]
2024-02-26
Study Identification, Study Status v4
Re-verified, no change to tracked fields
2024-01-22
Study Status, Study Description, Eligibility, Contacts/Locations v3
Eligibility criteriarevised
[...] (PS) 0 or 1 Negative pregnancy test done ≤ 7 days prior to registrationchemotherapy, for women of childbearing potential only Ability to provid [...]
Study description+15 characters
[...] , per Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. II. Assess post-operative toxicity for patients undergoing [...]
Study sitesdetails revised at 1 of 3 sites
2023-11-21
Not Yet Recruiting→Recruiting Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-10-31→confirmed 2023-11-20
Study sitesdetails revised at 3 of 3 sites
Collaborators-31 characters
National Cancer Institute (NCI)
2023-10-11
Study Status, Outcome Measures v1
Secondary endpointsdetails revised at 1 of 11 entries
2023-10-09
Original filing
Mayo Clinic
1,015 trials monitored
See 115 trials at risk
Esophageal Cancer
1,010 trials monitored
See 51 trials at risk
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.
Trial Details
NCT Number NCT06078709
Lead Sponsor Mayo Clinic
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
Enrollment 99 participants
Start Date 2023-11-21
Primary Completion 2029-05-25 (estimated)
Study Completion 2029-05-25 (estimated)
Updated on ClinicalTrials.gov 2026-10-01