Radioterapia de dosis ultrabaja para el tratamiento de pacientes con linfoma MALT de estómago en estadio I-IV
Dosis ultrabaja de radiación de 4 Gy para el tratamiento definitivo del linfoma MALT gástrico
This trial studies how well ultra low-dose radiation therapy works in treating patients with stage I-IV stomach mucosa-associated lymphoid tissue (MALT) lymphoma. Ultra low-dose radiation therapy may be able to kill tumor cells and shrink tumors while having fewer side effects in patients with MALT lymphoma.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
PRIMARY OBJECTIVE:
I. To evaluate the efficacy of ultra-low dose 4 Gy gastric radiation, measured as complete gastric response at one year after 4 Gy treatment in patients with marginal zone lymphoma involving the stomach (mucosa-associated lymphoid tissue [MALT]).
SECONDARY OBJECTIVES:
I. To evaluate distant recurrence of marginal zone lymphoma at one year. II. To evaluate toxicity associated with gastric radiation therapy.
EXPLORATORY OBJECTIVES:
I. To determine if microbiome assessment can predict response to ultra-low dose radiation therapy and evaluate the differences in patient microbiome for patients who respond well and poorly to low dose radiation.
II. To determine if micro-ribonucleic acid (RNA) assessment can predict response to ultra-low dose radiation therapy and evaluate the differences in patient microRNA profiles for patients who respond well and poorly to low dose radiation.
III. To explore the role of magnetic resonance imaging (MRI) for staging gastric MALT lymphoma and for predicting response to ultra-low dose radiation therapy.
IV. To encourage optional co-enrollment on study PA18-0644 to facilitate collection and archiving of blood based biomarkers and microbiome samples for patients receiving ultra low dose radiation therapy.
OUTLINE:
Patients undergo low-dose radiation therapy over 2 fractions for 2 consecutive days in the absence of disease progression or unacceptable toxicity. Patients with stable or progressive disease at 12-16 weeks post-treatment, or persistent disease at 1 year may undergo higher-dose radiation therapy at the discretion of treating physician.
After completion of study treatment, patients are followed up every 3 months for up to 1 year.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase temprana 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Texas
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Houston, Texas, Estados Unidos, 77030
- M D Anderson Cancer Center
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patients 18 years or older with stage I-IV MALT lymphoma involving the stomach. Other low grade lymphomas including follicular grade I/II and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) are ineligible
- Patients must have biopsy-proven disease within the stomach. Patients with clinical and/or radiographic masses will have dimensions noted prior to therapy
- Patients must have H. pylori testing which is negative within 6 months prior to treatment
- Female patients of childbearing potential must have a negative serum pregnancy test (human chorionic gonadotropin [hCG]) within 2 weeks of protocol entry
- Planned systemic therapy prior to, during, or after gastric radiation therapy is permitted however the timing of systemic therapy will be recorded and patients will be stratified according to receipt of systemic therapy
- Patients must have the ability to give informed consent
- Necessary treatment with antibiotics for reasons unrelated to gastric lymphoma is permitted however the timing and nature of the treatment will be recorded
Exclusion Criteria:
- Patients with aggressive B cell lymphoma histology, including diffuse large B cell lymphoma (DLBCL) and grade 3 follicular lymphoma
- Patients with other histologic subtypes of low grade lymphoma (other than MALT) including chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) or follicular lymphoma
- Patients with bulky tumors > 10 cm in any dimension
- Patients with a history of prior radiation to the stomach if re-treatment would exceed known gastric or surrounding critical structure (e.g., bowel, spinal cord) tolerance
- Patients who are pregnant
- Patients with scleroderma are ineligible
Plan de estudios
¿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 (low-dose radiation therapy)
Patients undergo low-dose radiation therapy over 2 fractions for 2 consecutive days in the absence of disease progression or unacceptable toxicity. Patients with stable or progressive disease at 12-16 weeks post-treatment, or persistent disease at 1 year may undergo higher-dose radiation therapy at the discretion of treating physician. |
Undergo ultra low-dose radiation
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Complete gastric response
Periodo de tiempo: Up to 1 year
|
The complete response rate at one year will be estimated along with 95% confidence intervals. |
Up to 1 year
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Distant recurrence defined as disease progression outside of the stomach that was not present initially
Periodo de tiempo: Up to 1 year
|
Distant recurrence rate at one year will be estimated along with 95% confidence intervals. |
Up to 1 year
|
|
Incidence of acute gastrointestinal toxicity graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.03
Periodo de tiempo: Up to 1 year
|
Toxicity data will be summarized by frequency tables. |
Up to 1 year
|
|
Incidence of chronic gastrointestinal toxicity graded according to CTCAE v. 4.03
Periodo de tiempo: Up to 1 year
|
Toxicity data will be summarized by frequency tables. |
Up to 1 year
|
|
Time to local gastric event
Periodo de tiempo: Up to 1 year
|
Will be estimated using the Kaplan-Meier method. |
Up to 1 year
|
|
Time to distant event
Periodo de tiempo: Up to 1 year
|
Will be estimated using the Kaplan-Meier method. |
Up to 1 year
|
|
Tumor response
Periodo de tiempo: Up to 1 year
|
The tumor responses will be summarized stratified by systemic treatments. |
Up to 1 year
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jillian Gunther, M.D. Anderson Cancer Center
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2018-0392
- 2018-0392 (Otro identificador: M D Anderson Cancer Center)
- NCI-2018-01948 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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