Ablative Stereotactic MR-Guided Adaptive Reirradiation
Abdominal Cancer · Pelvic Cancer
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 11 Real
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
This research study will enroll people who have cancer in their abdomen or pelvis that was treated previously with radiation therapy. The purpose of this research study is to test the safety and possible harms of treating tumors in these regions with another round of radiation therapy, called reirradiation or "reRT." The researchers want to find out what effects (good and bad) reRT has in people with cancer in the abdomen and pelvis.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
- A primary or metastatic lesion in the abdomen or pelvis for which reirradiation will be delivered. There is no maximum lesion size.
- Single course of prior radiation therapy with prescribed equivalent dose in 2 Gy fractions (EDQ210) of at least 40 Gy.
- 50% isodose line of the prior radiation therapy course is expected to overlap at minimum the 50% isodose line of the radiation therapy delivered in this study.
- At least 6 months from completion of prior radiation therapy to initiation of study therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Life expectancy at least 6 months.
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Abstinence is acceptable if it is the participant's preferred method. Should a participant become pregnant or suspect pregnancy while participating in this study, the treating physician must be informed immediately.
- Concurrent hormonal therapy or immunotherapy such as immune checkpoint inhibitor is allowed
Exclusion Criteria:
- Contraindication to having an MRI scan.
- Lesion that would receive study therapy arises from or invades a gastrointestinal (GI) luminal organ (a lesion abutting but not invading a GI luminal organ is permitted)
- Lesion that would receive study therapy is not located in the abdomen or pelvis.
- \> 1 course of overlapping radiation therapy delivered to the abdomen or pelvis.
- \< 70% of the gross tumor volume (GTV) receives at least the 95% of the prescribed dose on the original plan using the simulation day anatomy.
- More than 1 lesion in the abdomen or pelvis that requires reirradiation.
- History of inflammatory bowel disease.
- Unable to acquire DICOM radiation therapy treatment plan from the prior radiation therapy.
- Unresolved grade 2+ toxicity (Common Terminology Criteria for Adverse Events version 5.0) from previous anti-cancer therapy.
- Any condition in the opinion of the investigator that would interfere with evaluation of study treatment or interpretation of participant safety or study results.
- Individuals who are pregnant.
- Chemotherapy given within 1 week prior to or following reirradiation.
- Vascular endothelial growth factor (VEGF) inhibitor given within 8 weeks prior to or following reirradiation
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No aplica
- Enmascaramiento
- Sin enmascaramiento
Ablative Reirradiation
No informado en este registro.
Radiation: Reirradiation
Reirradiation RADIATION
Ablative reirradiation of 50 Gy in 5 fractions (5 sessions) that will occur once per day, either for 5 days in a row, or every other day.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Grade 3 or higher acute toxicity
Plazo: 1 year
Number of participants who experience Grade 3 or higher acute toxicity \[graded per Common Terminology Criteria for Adverse Events (CTCAE)\] possibly, probably, or definitely related to reRT.
Grade 5 toxicity
Plazo: 1 year
Number of participants who experience Grade 5 toxicity (graded per CTCAE) possibly, probably, or definitely related to reRT.
Medidas secundarias
Freedom from local progression (FFLP)
Plazo: 1 year
FFLP is defined as the duration of time from baseline to progressive disease (PD) in the re-irradiated lesion or death of any cause, whichever occurs first. Response to treatment will be assessed using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Overall survival (OS)
Plazo: 1 year
OS is defined as the defined as the duration of time from baseline to death of any cause, or date of last follow-up, whichever occurs first.
Grade 3 or higher late toxicity
Plazo: 1 year
Number of participants who experience Grade 3 or higher acute toxicity \[graded per Common Terminology Criteria for Adverse Events (CTCAE)\] possibly, probably, or definitely related to reRT that occurs at least 90 days after reRT therapy has ended.
Quality of life (QOL)
Plazo: 1 year
QOL will be assessed using the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire. The FACT-G is a 27-item questionnaire measuring physical, social, emotional, and functional well-being. All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much), with a possible range of 0-108 points. Negatively worded items are reverse scored prior to summing so that higher scores indicate better QOL.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
1 centros
Miami Cancer Institute at Baptist Health South FloridaMiami, Florida, United StatesEstado desconocido
Equipo y fechas
- Patrocinador principal
- Baptist Health South Florida
- Inicio del estudio
- 5 jun 2024 Real
- Finalización primaria
- 20 ago 2026 Real
- Finalización del estudio
- 20 ago 2026 Real
- Primera publicación
- 3 may 2024 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Phase 1 Trial of Ablative Stereotactic MR-Guided Adaptive Reirradiation for Abdominal and Pelvic Tumors
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026