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Terapia con haz de protones en el tratamiento del cáncer de esófago

10 de septiembre de 2026 actualizado por: Washington University School of Medicine

Un estudio de fase II de la terapia con haz de protones en el tratamiento del cáncer de esófago

The investigators plan to include both operable and inoperable patients with esophagus cancer in this prospective trial. Since both proton and photon treatments are biologically equivalent, the investigators do not expect a difference in tumor control compared to intensity modulated radiation therapy (IMRT). The investigators have a prospective experience of physician-reported toxicity and patient outcome using IMRT for patients with inoperable esophagus cancer that will serve as a comparison group. For the resectable patients receiving trimodality therapy (chemoradiation followed by surgery), the investigators will carefully track toxicity and patient outcomes prospectively. The central hypothesis is that the biologic efficacy for tumor control should be similar between protons and photons, and therefore survival measures should be similar between the two groups, but that the main difference lies in the total severe toxicities experienced by the patients undergoing therapy.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

22

Fase

  • No aplica

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.

Ubicaciones de estudio

  • Estados Unidos
    • Missouri
      • St Louis, Missouri, Estados Unidos, 63110
        • Washington University School of Medicine

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:

  • Histologically or cytologically documented adenocarcinoma or squamous cell carcinoma of the cervical or thoracic esophagus or gastroesophageal junction or cardia of stomach.

  • Staged by PET/CT and esophagogastroduodenoscopy (EGD) or endoscopic ultrasound (EUS) OR CT w/contrast and EGD to have stage II or III disease per AJCC 7th edition guidelines

  • Prior endoscopic mucosal resection (EMR) with a diagnosis of stage II or III esophageal cancer (AJCC 7th edition) is eligible, irrespective of margin status.

  • Induction chemotherapy prior to concurrent chemoradiation is allowed.

  • Prior thoracic radiation is allowable if degree of overlap with the esophageal radiotherapy treatment is deemed to be safe by the treating radiation oncologist.

  • At least 18 years of age.

  • ECOG performance status < 2

  • Normal bone marrow and organ function as defined below:

    • WBC > 2,500/mcL
    • Platelets > 75,000/mcl
    • Total bilirubin < 1.5 x institutional upper limit of normal (IULN)
    • AST(SGOT)/ALT(SGPT) < 3.0 x IULN
    • Creatinine < 1.5 x IULN OR Creatinine clearance > 50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal

  • Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.

  • Ability to understand and willingness to sign an IRB approved written informed consent document.

  • English speaker.

  • Financial coverage for proton therapy.

Exclusion Criteria:

  • Planned treatment with radiation therapy alone without concurrent chemotherapy or chemotherapy alone.
  • Previous or concomitant cancers within the past 3 years other than curatively treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, curative treatment for transitional cell carcinoma of the bladder, and low risk prostate cancer. Except for prostate cancer (which can be observed if low risk), other cancers listed must have been treated in the past 3 years without evidence of recurrence at the time of registration.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia not controlled by pacer device, myocardial infarction within 3 months of registration, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 7 days of the start of treatment.

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: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Arm 1: Resectable (proton beam therapy)
  • Proton beam therapy: total dose of 50 or 50.4 Gy
  • Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision
  • Surgery should ideally be performed no later than 8 to 10 weeks after completing chemoradiation
  • Patient-reported outcome measures (PROs) performed at several time points
Radiación: Proton beam therapy
  • The daily prescription dose will be 1.8 or 2 Gy RBE ("Relative Biologic Equivalence") to be delivered to the periphery of the planning target volume (PTV).
  • The Mevion S-250 Proton Radiation Beam Therapy System will be used.
Otros nombres:
  • PBT
Otro: Patient-Reported Outcome Measures

-Prior to start of therapy, end of chemoradiation (day of end of treatment or up to 1 week after), 8 weeks, 4, 6, 9, and 12-months following end of chemoradiation

Otros nombres:
  • PRO
Experimental: Arm 2: Unresectable (proton beam therapy)
  • Proton beam therapy: total dose of 59.4 or 60 Gy
  • Standard of care chemotherapy - the clinical trial doesn't dictate anything about the chemotherapy given, it is the treating physician's decision
  • Patient-reported outcome measures (PROs) performed at several time points
Radiación: Proton beam therapy
  • The daily prescription dose will be 1.8 or 2 Gy RBE ("Relative Biologic Equivalence") to be delivered to the periphery of the planning target volume (PTV).
  • The Mevion S-250 Proton Radiation Beam Therapy System will be used.
Otros nombres:
  • PBT
Otro: Patient-Reported Outcome Measures

-Prior to start of therapy, end of chemoradiation (day of end of treatment or up to 1 week after), 8 weeks, 4, 6, 9, and 12-months following end of chemoradiation

Otros nombres:
  • PRO

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus
Periodo de tiempo: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months

The MDASI-Plus is a reliable, validated tool for assessing cancer-related symptoms regardless of therapy or specific cancer diagnosis. Patients are asked to fill out a twenty-seven question inventory. 21 questions ask the patient about the severity of their symptoms with answers ranging from 0=not present to 10=as bad as you can imagine. 6 questions ask the patient about how their symptoms interfered with their life with answers ranging from 0=did not interfere to 10=interfered completely. The higher the score the more severe symptom experience the patient experienced.
Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire
Periodo de tiempo: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months

The EQ-5D is a standardized 2-part, patient-administered instrument used for direct and indirect assessment of health state utilities. The first part asks respondents to "check the ONE box [next to the appropriate statement] that best describes your health TODAY" for each of 5 health dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The second part of the EQ-5D is a visual analogue scale (VAS) valuing current health state. Both the 5-item index score and the VAS score are transformed into a utility score between 0 "Worst health state" and 1 "Best health state. The higher the score the better health a patient experienced.
Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey
Periodo de tiempo: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months

The 19-item MOS Social Support Survey was designed for use with patients with chronic diseases and measures how often different kinds of support are available, if needed. Response choices range from "none of the time" (1) to "all of the time" (5). A mean social support score for all 19 items is computed to a 0-100 scale with higher scores indicating a greater availability of social support.
Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D)
Periodo de tiempo: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months

The CES-D questionnaire is a 20-item measure which evaluates depressive symptoms. This trial will make use of the validated 4-item screening version in order to reduce participant burden. Possible range of scores is 0-60, with the higher scores indicating the presence of more symptomatology.
Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the MD Anderson Symptom Inventory (MDASI)-Plus
Periodo de tiempo: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

The MDASI-Plus is a reliable, validated tool for assessing cancer-related symptoms regardless of therapy or specific cancer diagnosis. Patients are asked to fill out a twenty-seven question inventory. 21 questions ask the patient about the severity of their symptoms with answers ranging from 0=not present to 10=as bad as you can imagine. 6 questions ask the patient about how their symptoms interfered with their life with answers ranging from 0=did not interfere to 10=interfered completely. The higher the score the more severe symptom experience the patient experienced.
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the EuroQol (EQ-5D) Questionnaire
Periodo de tiempo: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

The EQ-5D is a standardized 2-part, patient-administered instrument used for direct and indirect assessment of health state utilities. The first part asks respondents to "check the ONE box [next to the appropriate statement] that best describes your health TODAY" for each of 5 health dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The second part of the EQ-5D is a visual analogue scale (VAS) valuing current health state. Both the 5-item index score and the VAS score are transformed into a utility score between 0 "Worst health state" and 1 "Best health state. The higher the score the better health a patient experienced.
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the Medical Outcomes Study (MOS) Social Support Survey
Periodo de tiempo: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

The 19-item MOS Social Support Survey was designed for use with patients with chronic diseases and measures how often different kinds of support are available, if needed. Response choices range from "none of the time" (1) to "all of the time" (5). A mean social support score for all 19 items is computed to a 0-100 scale with higher scores indicating a greater availability of social support.
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the 4-Item Center for Epidemiological Studies Depression Scale (CES-D)
Periodo de tiempo: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

The CES-D questionnaire is a 20-item measure which evaluates depressive symptoms. This trial will make use of the validated 4-item screening version in order to reduce participant burden. Possible range of scores is 0-60, with the higher scores indicating the presence of more symptomatology.
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Physician-reported Toxicity of PBT for Esophageal Cancer
Periodo de tiempo: Through 6 months following chemoradiation (estimated to be 9 months)

Number of participants with grade 3 or higher specific cardiac, metabolism/nutrition, gastrointestinal, respiratory/thoracic/mediastinal, and skin/subcutaneous toxicity using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 related to PBT
Through 6 months following chemoradiation (estimated to be 9 months)
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score
Periodo de tiempo: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher scores indicate better quality of life.

MCS scores from the SF-12 are recoded, weighted, and summed, and standardized by the SF-12 scoring procedure. SF-12 is a licensed product and this procedure is implemented in the QualityMetric PRO CoRE software package. MCS range is 40-65.
Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score
Periodo de tiempo: Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher scores indicate better quality of life.

PCS scores from the SF-12 are recoded, weighted, and summed, and standardized by the SF-12 scoring procedure. SF-12 is a licensed product and this procedure is implemented in the QualityMetric PRO CoRE software package. PCS range is 30-55.
Baseline, post completion of chemoradiation, 2 months, 4 months, and 6 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Component Score
Periodo de tiempo: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher scores indicate better quality of life.

PCS scores from the SF-12 are recoded, weighted, and summed, and standardized by the SF-12 scoring procedure. SF-12 is a licensed product and this procedure is implemented in the QualityMetric PRO CoRE software package. PCS range is 30-55.
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Component Score
Periodo de tiempo: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher scores indicate better quality of life.

MCS scores from the SF-12 are recoded, weighted, and summed, and standardized by the SF-12 scoring procedure. SF-12 is a licensed product and this procedure is implemented in the QualityMetric PRO CoRE software package. MCS range is 40-65.
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - General Health Score
Periodo de tiempo: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Lower mean scores indicate better quality of life.

The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-5.
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Function Score
Periodo de tiempo: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher mean scores indicate better quality of life.

The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-3.
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Physical Role Score
Periodo de tiempo: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher mean scores indicate better quality of life.

The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-2.
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Emotional Role Score
Periodo de tiempo: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher mean scores indicate better quality of life.

The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-2.
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Bodily Pain Score
Periodo de tiempo: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Lower mean scores indicate better quality of life.

The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-5.
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Mental Health Score
Periodo de tiempo: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Lower mean scores indicate better quality of life.

The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-6.
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Vitality Health Score
Periodo de tiempo: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Lower mean scores indicate better quality of life.

The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-6.
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months
Change in Patient-reported Outcomes of PBT for Esophageal Cancer as Measured by the SF-12 Questionnaire - Social Functioning Score
Periodo de tiempo: Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

The SF-12 will be measured at each of 7 interviews, and mental and physical component scores will be calculated in addition to calculating the measure's eight individual subscales (physical functioning, social functioning, role limitations due to physical problems, body pain, general health, role limitations due to emotional problems general health, vitality, and mental health). Higher mean scores indicate better quality of life.

The subscales are calculated by recoding and averaging the raw scores (Likert scales) the questions associated with the subscale. Range of 1-5.
Baseline, post completion of chemoradiation, 2 months, 4 months, 6 months, 9 months, and 12 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Supervivencia general (SG) de PBT para pacientes con esófago resecable versus no resecable
Periodo de tiempo: 5 años después de la quimiorradiación (estimada en 5 años y 3 meses)
5 años después de la quimiorradiación (estimada en 5 años y 3 meses)
Progression-free Survival (PFS) of Proton Beam Therapy (PBT) for Patients With Resectable
Periodo de tiempo: 5 years following chemoradiation (estimated to be 5 years and 3 months)

-PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
5 years following chemoradiation (estimated to be 5 years and 3 months)

Colaboradores e Investigadores

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

Patrocinador

Washington University School of Medicine

Investigadores

  • Investigador principal: Gregory Vlacich, M.D., Ph.D., Washington University School of Medicine

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)

19 de abril de 2018

Finalización primaria (Actual)

13 de septiembre de 2022

Finalización del estudio (Actual)

9 de septiembre de 2026

Fechas de registro del estudio

Enviado por primera vez

15 de marzo de 2018

Primero enviado que cumplió con los criterios de control de calidad

22 de marzo de 2018

Publicado por primera vez (Actual)

29 de marzo de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de octubre de 2026

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

10 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

  • 201803092

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

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

No

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

Sí

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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