- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03258671
IMRT and Timing in Combination With EGFRTKI for Stage IV Non-small-cell Lung Cancer
IMRT and Timing in Combination With EGFRTKI for Stage IV Non-small-cell Lung Cancer: Results of a Randomised,Openlabel,Multicentre Study
This study is for patients with EFGR gene sensitive mutations diagnosed by pathology or cytology, having a course of chest radiotherapy treatment and molecular Target Therapy for the treatment of stage IV non-small cell lung cancer. Patients with non-small cell lung cancer have a risk of the tumour in the lung recurring or progressing after treatment.
In this study, the investigators aim to verify the following hypothesis:
- whether in combination with concurrent or concomitant EGFR-TKI regimen chemotherapy, Intensity Modulated Radiation Therapy can reduce the risk of the tumour in the lung recurring or progressing similarily.
- Intensity Modulated Radiation Therapy concomitant with EGFR-TKI has a better normal tissue dose/volume tolerance than concurrent regimen.
- the survival can be improved by using this new molecular Target-radiotherapy method.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Lu Bing, Director
- Número de teléfono: 86-18275356814
- Correo electrónico: ouyangww103173@163.com
Ubicaciones de estudio
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Guizhou
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Guiyang, Guizhou, Porcelana, 550004
- The Affiliated Hospital Of Guizhou Medical University
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Contacto:
- Lu Bing, MD
- Número de teléfono: 86-18275356814
- Correo electrónico: ouyangww103173@163.com
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Histologically or cytologically confirmed stage IV NSCLC[UICC 2017 8th edition] with known sensitive EGFR mutations(confirmed by tissue or blood).
- Have not received one or more prior treatments
- 18 to 80 years of age.ECOG performance status 0~2 or KPS≥60
- Have distant metastatic lesions≤5;and have clear consciousness when the metastatic sites were brain; and have no influence on pulmonary function when the metastatic sites were lung.
- Have no contraindications in radiotherapy, EGFR-TKI and chemotherapy
- Normal bone marrow and organ function as defined below:
Absolute neutrophil count ≥ 1,500/mcl Platelets ≥ 100,000/mcl Hemoglobin ≥ 9.0 g/dL Total bilirubin ≤ 2.0 x IULN AST (SGOT) / ALT (SGPT) ≤ 3.0 x IULN; if liver metastases, ≤ 5.0 x IULN Serum creatinine ≤ 1.5 x ULN LVEF ≥ 50% performed no more than 4 weeks prior to enrollment. FEV1>50%,mild-moderate pulmonary function dysfunction.
- Able to understand and willing to sign a Human Research Protection Office (HRPO) approved written informed consent document (or that of legally authorized representative, if applicable).
- With good compliance to the treatment and Follow-up
Exclusion Criteria:
- Evidence of small cell, large cell neuroendocrine or carcinoid histology.
- Non-stage IV NSCLC and ECOG performance status 3~5 or KPS<60
- Have a serious or uncontrolled medical condition that could compromise the patients' ability to adhere to the protocol.
- Malignant pleural effusion and pericardial effusion
- Uncontrolled intercurrent illness including, but not limited to, hypertension , diabetes mellitus ,ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant and/or breastfeeding: Patient must have a negative pregnancy test within 14 days of study entry.
- Have a secondary malignancy (except adequately treated non-melanomatous skin cancer, or other cancer such as in situ of the cervix. considered cured by surgical resection or radiation). Patients who have had another malignancy in the past but have been disease free for more than 5 years are eligible.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to EGFR-TKI or other agents used in the study.
- With poor compliance
- The researchers consider it inappropriate to participate in the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Mutation+ concurrent
IMRT concurrent with EGFR-TKI on paticipants with known sensitive EGFR mutations.
|
·EGFR-TKI:gefitinib will be administered 250mg/d ivgtt qd; icotinib will be administered 150mg/d ivgtt tid;
High dose group:DTGTV=70Gy;
Low dose group:DTGTV=50Gy;
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Experimental: Mutation+ concomitant
IMRT concomitant with EGFR-TKI on paticipants with known sensitive EGFR mutations.
|
·EGFR-TKI:gefitinib will be administered 250mg/d ivgtt qd; icotinib will be administered 150mg/d ivgtt tid;
High dose group:DTGTV=70Gy;
Low dose group:DTGTV=50Gy;
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Therapeutic efficacy of EGFR-TKI and concurrent/concomitant local RT in NSCLC patients.
Periodo de tiempo: >4 weeks post treatment
|
Tumor Response will be evaluated using the RECIST system.
Modified WHO criteria will be used for measurement of tumors.
The irradiated lesion will be excluded from the assessment of response.
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>4 weeks post treatment
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Overall survival (OS)
Periodo de tiempo: Up to 5 years
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Overall survival is defined as the time interval from date of diagnosis to date of death from any cause
|
Up to 5 years
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Progression-free survival (PFS)
Periodo de tiempo: Up to 5 years
|
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progressive disease (PD) = at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, appearance of one or more non-target lesion(s) and/or unequivocal progression of existing non-target lesions |
Up to 5 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Objective response rate(ORR)
Periodo de tiempo: Up to 5 years
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Partial response + complete response per RECIST 1.1 criteria Complete response (CR) = disappearance of all target lesions, non-target lesions, and normalization of tumor marker level Partial response (PR) = at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline of sum diameters |
Up to 5 years
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Disease control rate (DCR)
Periodo de tiempo: Up to 5 years
|
Percentage of patients who achieve complete response, partial response, or stable disease per RECIST 1.1 criteria. Complete response (CR) = disappearance of all target lesions, non-target lesions, and normalization of tumor marker level Partial response (PR) = at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline of sum diameters Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
Up to 5 years
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Eventos adversos (toxicidades)
Periodo de tiempo: Hasta 5 años
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Las descripciones y escalas de calificación que se encuentran en los Criterios de Terminología Común para Eventos Adversos (CTCAE) revisados del NCI, versión 4.0, se utilizarán para todos los informes de toxicidad.
|
Hasta 5 años
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Local regional progression-free survival(LRPFS)
Periodo de tiempo: Time Frame: Up to 5 years
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LRPFS is defined as the duration of time from start of treatment to time of progression or recurrence, whichever occurs first..The target lesions is only for primary tumor and regional positive lymph nodes. Progressive disease (PD) = at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, appearance of one or more target lesion(s) and/or unequivocal progression of existing target lesions. |
Time Frame: Up to 5 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Lu Bing, Director, ouyangww103173@163.com
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
- CSWOG
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.
producto fabricado y exportado desde los EE. UU.
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