Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma

NCT06078709 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: GMROR2241NCI-2023-0743223-001689
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Clinical Stage II Esophageal Adenocarcinoma AJCC v8; Clinical Stage III Esophageal Adenocarcinoma AJCC v8; Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage I Esophageal Adenocarcinoma AJCC v8; Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8

Outcome Measures

Primary Outcomes (1)

• 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).

  Up to 5 years after completion of chemoradiation

Secondary Outcomes (11)

• Incidence of acute ≥ gastrointestinal (GI) adverse events (AEs)

  Up to 6 weeks after completion of chemoradiation

• Incidence of post operative AEs

  From surgery up to 6 months after completion of chemoradiation

• Patient-reported quality of life (QOL)

  Up to 24 months after completion of chemoradiation

• Financial toxicity

  Up to 24 months after completion of chemoradiation

• Overall survival (OS)

  From study entry to death from any cause, up to 5 years after completion of chemoradiation

Study Arms (1)

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.

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

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (FLOT and Radiation and FOLFOX)

Computed Tomography PROCEDURE

Undergo CT and PET/CT scan

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography, Computerized Tomography (CT) scan

Treatment (FLOT and Radiation and FOLFOX)

Endoscopic Ultrasound PROCEDURE

Undergo EUS

Also known as: endosonography, EUS

Treatment (FLOT and Radiation and FOLFOX)

Esophagogastroduodenoscopy PROCEDURE

Undergo EGD

Also known as: EGD, Upper Endoscopy

Treatment (FLOT and Radiation and FOLFOX)

Fluorouracil DRUG

Given IV

Also known as: 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-Fu, 5FU, AccuSite, Carac, Fluoro Uracil, Fluouracil, Flurablastin, Fluracedyl, Fluracil, Fluril, Fluroblastin, Ribofluor, Ro 2-9757, Ro-2-9757, 2,4-Dioxo-5-fluoropyrimidine, 51-21-8

Treatment (FLOT and Radiation and FOLFOX)

Oxaliplatin DRUG

Given IV

Also known as: 1-OHP, Ai Heng, Aiheng, Dacotin, Dacplat, Diaminocyclohexane Oxalatoplatinum, Eloxatin, Eloxatine, JM-83, Oxalatoplatin, Oxalatoplatinum, RP 54780, RP-54780, SR-96669, JM83, RP54780, SR96669

Treatment (FLOT and Radiation and FOLFOX)

Hypofractionated Radiation Therapy RADIATION

Undergo hypofractionated radiation therapy

Also known as: Hypofractionated, Hypofractionated Radiotherapy, hypofractionation, Radiation, Hypofractionated

Treatment (FLOT and Radiation and FOLFOX)

Leucovorin Calcium DRUG

Given IV

Also known as: Adinepar, Calcifolin, Calcium (6S)-Folinate, Calcium Folinate, Calcium Leucovorin, Calfolex, Calinat, Cehafolin, Citofolin, Citrec, Citrovorum Factor, Cromatonbic Folinico, Dalisol, Disintox, Divical, Ecofol, Emovis, Factor, Citrovorum, Flynoken A, Folaren, Folaxin, FOLI-cell, Foliben, Folidan, Folidar, Folinac, Folinate Calcium, folinic acid, Folinic Acid Calcium Salt Pentahydrate, Folinoral, Folinvit, Foliplus, Folix, Imo, Lederfolat, Lederfolin, Leucosar, leucovorin, Rescufolin, Rescuvolin, Tonofolin, Wellcovorin

Treatment (FLOT and Radiation and FOLFOX)

Positron Emission Tomography PROCEDURE

Undergo PET and PET/CT scan

Also known as: Medical Imaging, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT

Treatment (FLOT and Radiation and FOLFOX)

Survey Administration OTHER

Ancillary studies

Treatment (FLOT and Radiation and FOLFOX)

Docetaxel DRUG

Given IV

Also known as: 148408-66-6, Docecad, N-Debenzoyl-N-(tert-butoxycarbonyl)-10-deacetyltaxol, RP 56976, RP-56976, RP56976, Taxotere

Treatment (FLOT and Radiation and FOLFOX)

Durvalumab BIOLOGICAL

Given IV

Also known as: Imfinzi, MEDI 4736, MEDI-4736, MEDI4736, Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Immunoglobulin G1

Treatment (FLOT and Radiation and FOLFOX)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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:
• Pregnant women
• Nursing women
• Men or women of childbearing potential who are unwilling to employ adequate contraception

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

NOT YET RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

ACTIVE NOT RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Specimen Handling; Endoscopic Ultrasound-Guided Fine Needle Aspiration; Endoscopy, Digestive System; Gastroscopy; Fluorouracil; dehydroftorafur; Radiation Dose Hypofractionation; Radiation; Leucovorin; Oxaliplatin; Magnetic Resonance Spectroscopy; X-Rays; Docetaxel; durvalumab; Disulfides; Immunoglobulin G

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Image-Guided Biopsy; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Digestive System; Endoscopy; Digestive System Surgical Procedures; Endoscopy, Gastrointestinal; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics; Physical Phenomena; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals; Spectrum Analysis; Chemistry Techniques, Analytical; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Radiation, Ionizing; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Sulfides; Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrogen Sulfide; Sulfur Compounds; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Christopher L. Hallemeier, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 12, 2023
• Study Start: November 20, 2023
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

US (3)