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Radioterapia hipofraccionada preoperatoria con FOLFOX para el adenocarcinoma de esófago o de la unión gastroesofágica (PHOX)

29 de septiembre de 2026 actualizado por: Mayo Clinic

Radioterapia hipofraccionada preoperatoria con FOLFOX para el adenocarcinoma de esófago / unión gastroesofágica (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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

PRIMARY OBJECTIVE:

I. To demonstrate non-inferiority of pathologic complete response (pCR) with hypofractionated radiotherapy and concurrent FOLFOX compared to historical controls.

SECONDARY OBJECTIVES:

I. 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).

V. 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.

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 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.

V. 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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

99

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Estados Unidos
    • Arizona
      • Scottsdale, Arizona, Estados Unidos, 85259
        • Aún no reclutando
        • Mayo Clinic in Arizona
        • Contacto:
        • Investigador principal:
          • Jonathan B. Ashman, MD, PhD
    • Florida
      • Jacksonville, Florida, Estados Unidos, 32224-9980
        • Activo, no reclutando
        • Mayo Clinic in Florida
    • Minnesota
      • Rochester, Minnesota, Estados Unidos, 55905
        • Reclutamiento
        • Mayo Clinic in Rochester
        • Contacto:
        • Investigador principal:
          • Christopher L. Hallemeier, MD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Treatment (FLOT and Radiation and FOLFOX)

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.
Droga: Docetaxel

Given IV

Otros nombres:
  • Taxotere
  • Docecad
  • RP56976
  • RP 56976
  • RP-56976
  • 148408-66-6
  • N-Debenzoil-N-(terc-butoxicarbonil)-10-desacetiltaxol
Droga: Fluorouracil

Given IV

Otros nombres:
  • 5-fluracilo
  • Fluracilo
  • 5 fluorouracilo
  • 5 FU
  • 5-fluoro-2,4(1H, 3H)-pirimidindiona
  • 5-fluorouracilo
  • 5-fu
  • 5FU
  • AccuSite
  • Carac
  • Fluorouracilo
  • Fluoracilo
  • Flurablastina
  • Fluracedil
  • Fluril
  • Fluroblastina
  • Ribofluor
  • Ro 2-9757
  • Ro-2-9757
  • 2,4-dioxo-5-fluoropirimidina
  • 51-21-8
Procedimiento: Biospecimen Collection

Undergo blood sample collection

Otros nombres:
  • Recolección de muestras biológicas
  • Muestra biológica recolectada
  • Coleccion de especimenes
Droga: Leucovorin Calcium

Given IV

Otros nombres:
  • Wellcovorina
  • ácido folínico
  • Adinepar
  • Calcifolina
  • Calcio (6S)-folinato
  • Folinato de calcio
  • Leucovorina de calcio
  • Calfolex
  • Calinat
  • Cehafolina
  • Citofolina
  • Cítrec
  • Factor citrovorum
  • Cromatonbic Folinico
  • Dalisol
  • Desintoxicación
  • Divical
  • Ecofol
  • Emovis
  • Factor, Citrovorum
  • Flynoken A
  • Folarén
  • Folaxina
  • Célula FOLI
  • Foliben
  • Folidan
  • Foliar
  • Folinac
  • Sal de calcio del ácido folínico pentahidratado
  • Folinoral
  • Folinvit
  • Foliplus
  • Folix
  • Yo soy
  • Lederfolat
  • Lederfolin
  • Leucosar
  • leucovorina
  • Rescufolin
  • Rescuvolín
  • Tonofolina
Droga: Oxaliplatin

Given IV

Otros nombres:
  • 1-OHP
  • Dacotín
  • Dacplat
  • Eloxatina
  • Ai Heng
  • Aiheng
  • Diaminociclohexano Oxalatoplatino
  • JM-83
  • Oxalatoplatino
  • RP 54780
  • RP-54780
  • SR-96669
  • SR96669
  • JM83
  • RP54780
Radiación: Hypofractionated Radiation Therapy

Undergo hypofractionated radiation therapy

Otros nombres:
  • Radioterapia hipofraccionada
  • hipofraccionamiento
  • Radiación Hipofraccionada
  • Hipofraccionada
Otro: Survey Administration

Ancillary studies

Biológico: Durvalumab

Given IV

Otros nombres:
  • Imfinzi
  • MEDI-4736
  • MEDI4736
  • MEDIO 4736
  • Inmunoglobulina G1
  • Anti-(Proteína humana B7-H1) (Cadena pesada monoclonal humana MEDI4736)
  • Disulfuro con cadena Kappa monoclonal humana MEDI4736
Procedimiento: Esophagogastroduodenoscopy

Undergo EGD

Otros nombres:
  • EGD
  • Endoscopia superior
Procedimiento: Computed Tomography

Undergo CT and PET/CT scan

Otros nombres:
  • Connecticut
  • GATO
  • Análisis de gato
  • Tomografía Axial Computarizada
  • Tomografía axial computarizada
  • Tomografía computarizada
  • tomografía
  • Tomografía axial computarizada (procedimiento)
  • Tomografía computarizada (TC)
Procedimiento: Endoscopic Ultrasound

Undergo EUS

Otros nombres:
  • endosonografía
  • USE
Procedimiento: Positron Emission Tomography

Undergo PET and PET/CT scan

Otros nombres:
  • MASCOTA
  • Escaneo de mascotas
  • Tomografía por emisión de positrones
  • Tomografía de emisión de positrones
  • Imágenes espectroscópicas de resonancia magnética de protones
  • PT
  • Imagenes medicas
  • Tomografía por emisión de positrones (procedimiento)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Pathologic complete response
Periodo de tiempo: 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).
Up to 5 years after completion of chemoradiation

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of acute ≥ gastrointestinal (GI) adverse events (AEs)
Periodo de tiempo: Up to 6 weeks after completion of chemoradiation

Report acute grade ≥ 3 GI AEs per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 criteria. Will be summarized descriptively.
Up to 6 weeks after completion of chemoradiation
Incidence of post operative AEs
Periodo de tiempo: From surgery up to 6 months after completion of chemoradiation

Determined by the Clavien-Dindo Classification. Will be summarized descriptively.
From surgery up to 6 months after completion of chemoradiation
Patient-reported quality of life (QOL)
Periodo de tiempo: Up to 24 months after completion of chemoradiation

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.
Up to 24 months after completion of chemoradiation
Financial toxicity
Periodo de tiempo: Up to 24 months after completion of chemoradiation

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.
Up to 24 months after completion of chemoradiation
Overall survival (OS)
Periodo de tiempo: From study entry to death from any cause, up to 5 years after completion of chemoradiation

Will be assessed graphically using the Kaplan-Meier method. Summary statistics will be reported, including medians, 95% confidence intervals, etc.
From study entry to death from any cause, up to 5 years after completion of chemoradiation
Progression-free survival (PFS)
Periodo de tiempo: From study entry to the first of either disease progression or death, up to 5 years after completion chemoradiation

Will be assessed graphically using the Kaplan-Meier method. Summary statistics will be reported, including medians, 95% confidence intervals, etc.
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
Periodo de tiempo: Up to 5 years after completion of chemoradiation

Will be reported descriptively using CTCAE version 5.0 criteria.
Up to 5 years after completion of chemoradiation
Event free survival
Periodo de tiempo: From study entry to the first of either disease progression or recurrence or relapse or death, up to 5 years after completion of chemoradiation

Will be assessed graphically using the Kaplan-Meier method. Summary statistics will be reported, including medians, 95% confidence intervals, etc.
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
Periodo de tiempo: Up to 5 years after completion of chemoradiation

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.
Up to 5 years after completion of chemoradiation
Toxicity of chemoradiation between patients receiving proton based versus photon-based radiotherapy
Periodo de tiempo: Up to 5 years after completion of chemoradiation

Will be done descriptively, reporting frequencies and percentages between patients.
Up to 5 years after completion of chemoradiation
Toxicity of chemoradiation between groups receiving proton based versus photon-based radiotherapy
Periodo de tiempo: Up to 5 years after completion of chemoradiation

Will be done descriptively, reporting toxicity rates between groups using the chi-square test.
Up to 5 years after completion of chemoradiation

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Mayo Clinic

Investigadores

  • Investigador principal: Christopher L. Hallemeier, MD, Mayo Clinic in Rochester

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

21 de noviembre de 2023

Finalización primaria (Estimado)

25 de mayo de 2029

Finalización del estudio (Estimado)

25 de mayo de 2029

Fechas de registro del estudio

Enviado por primera vez

3 de octubre de 2023

Primero enviado que cumplió con los criterios de control de calidad

9 de octubre de 2023

Publicado por primera vez (Actual)

12 de octubre de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

29 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • GMROR2241
  • 23-001689 (Otro identificador: Mayo Clinic Institutional Review Board)
  • NCI-2023-07432 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
  • GMROR2241 (Otro identificador: Mayo Clinic Radiation Oncology)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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