- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01303926
Quality of Life Comparison in Advanced Non-squamous Non Small Cell Lung Cancer (ERACLE)
Induction Pemetrexed and Cisplatin Followed by Pemetrexed as Maintenance vs Carboplatin-paclitaxel and Bevacizumab Followed by Bevacizumab as Maintenance:Multicenter Randomized Phase III Study in Patients With Advanced Non-Squamous Non Small-cell Lung Cancer: a Quality of Life Oriented Phase III Trial of the GOIM
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The study aims primarily to verify the null hypothesis that between the two schemes under consideration there is no minimal interesting difference (MID) (i.e. a difference of clinical interest) after initial 3 months of maintenance.EuroQ5D (EQ5D) questionnaire total score and EQ5D visual analog scale (VAS)are validated and very simple to be administered.The statistical hypothesis tests described above are performed with t-test for unpaired data (or equivalent non-parametric, pending verification of normality of distribution by Shapiro-Wilk test), with alpha error = 0.05 (2-sided). It is assumed that:
- about 20% of randomized patients experienced a progression of disease before the time of evaluation of the primary endpoint, and that
- this eventuality was not significantly different between the two treatments. The total sample to be enrolled for this study will then be increased to 118 patients [(49 +49) +20%)]
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Napoli, Italia
- National Cancer Institute "G. Pascale" Thoracic Dept.
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BA
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Bari, BA, Italia, 70124
- "Giovanni Paolo II" Oncology Institute
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Bari, BA, Italia
- "San Paolo Hospital" Oncology Service
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BN
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Benevento, BN, Italia
- Division of Medical Oncology, "Fatebenefratelli" Hospital
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BR
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Brindisi, BR, Italia, 72100
- Division of Medical Oncology, "Sen. Perrino" Hospital, Brindisi, Italy
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FG
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San Giovanni Rotondo, FG, Italia
- 7 Division of Medical Oncology, "Casa Sollievo della Sofferenza" Hospital,
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Le
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Lecce, Le, Italia
- Medical Oncology Division "Vito Fazzi" Hospital
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PA
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Palermo, PA, Italia
- Division of Medical Oncology, "Buccheri-La Ferla" Hospital
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Palermo, PA, Italia
- Division of Medical Oncology, "La Maddalena" Hospital
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TA
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Castellaneta, TA, Italia
- Division of Medical Oncology, Castellaneta Hospital
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Taranto, TA, Italia
- Division of Medical Oncology "San Giuseppe Moscati Hospital"
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VE
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Mirano, VE, Italia
- Clinical Trials Office, Department of Medical Sciences, Azienda ULSS 13
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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:
- Written informed consent(as approved by the local Ethical Committee)
- Histological type consisting mainly of non-squamous histology defined preferably with stage IV metastatic disease or stage IIIB in the presence of supraclavicular lymph nodes according to the parameters of TNM 7th Ed, not amenable to curative therapy
- ECOG PS 0-1
- Adequate bone marrow reserve
- Adequate hepatic, coagulative and renal function
Exclusion Criteria:
- Mixed NSCLC tumors or mixed adenosquamous carcinomas with a predominant squamous component histotype (NSCLC and SCLC) or adenosquamous forms, with predominant squamous component
- History of gross hemoptysis <3 months prior to enrollment or history or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding.
- Tumors invading or abutting major blood vessels (based on radiologist assessment)
- Evidence of brain metastases not previously treated with RT (or any loco-regional treatment)
- Prior neoadjuvant or adjuvant chemotherapy within six months prior to study enrollment
- Previous radiotherapy in the last month before study entry (except for radiotherapy to symptomatic bone sites at risk and not covered in the premises of measurable disease and assessable)
- A major surgery (including open biopsy) in the month preceding study enrollment or anticipation of a major surgery during the study
- Unable or unwilling to take folic acid or vitamin B12 supplementation
- Unable or unwilling to take corticosteroids
- History of gastrointestinal fistula, perforation, or abscess, inflammatory bowel disease, or diverticulitis
- Clinically significant third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry
- Need for taking or have recently taken (within 10 days of enrollment) aspirin (>325 mg/d), clopidogrel at doses >75 mg/d, dipyramidole, ticlopidine, or cilostazol. Patients are also excluded if they cannot hold nonsteroidal anti-inflammatory agents, other than prophylactic therapy with low-dose aspirin, for a 5-day period during each cycle (8-day period for long-acting agents, such as piroxicam)
- Need for taking or have recently taken (within 10 days of enrollment) fulldose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes. Prophylactic use of anticoagulants is allowed; international normalized ratio (INR) should be <1.5 at study enrollment
- History of thrombotic disorders within the last 6 months prior to entry History of hypertension, unless hypertension is well controlled study entry (≤150/90 mm Hg) and the patient is on a stable regimen of antihypertensive therapy. Patients should not have any prior history of hypertensive crisis or hypertensive encephalopathy
- Serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV
- Serious concomitant systemic disorder (for example, active infection including human immunodeficiency virus) that, in the opinion of the investigator, would compromise the patient's ability to adhere to the protocol
- Receiving concurrent administration of any other antitumor therapy
- Have a second primary malignancy that is clinically detectable at the time of consideration for study enrollment
- Have had a prior malignancy other than NSCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence. Patients with a history of low grade (Gleason score ≤6) localized prostate cancer will be eligible even if diagnosed less than 5 years previously
- Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
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 |
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Comparador activo: Cisplatin and Pemetrexed
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Cisplatin 75 mg / m2 d1 with Pemetrexed 500 mg / m2 d1 every 3 weeks for 6 cycles followed (in responding or stable patients) by Pemetrexed 500 mg / m2 every 3 weeks, until progression or unacceptable toxicity
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Comparador activo: Carboplatin paclitaxel bevacizumab
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Carboplatin AUC 6 d1 plus Paclitaxel 200 mg/m2 d1 and Bevacizumab 15 mg/kg every 3 weeks for 6 cycles followed in stable or responding patients by Bevacizumab 15 mg/kg every 3 weeks, until progression or unacceptable toxicity
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Difference in terms of quality of life (QOL) between treatment arms
Periodo de tiempo: Treatment efficacy will be evaluated at baseline and every 3 cycles during chemo period and every two months during the maintenance phase
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Treatment efficacy will be evaluated at baseline and every 3 cycles during chemo period and every two months during the maintenance phase
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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treatment activity in terms of response rate
Periodo de tiempo: Two year
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Two year
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toxicity evaluation
Periodo de tiempo: Two years
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Two years
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Evaluation of QoL across time
Periodo de tiempo: Two years
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Two years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Giuseppe Colucci, MD, Oncology Institute of Bari
- Director de estudio: Domenico Galetta, MD, "Giovanni Paolo II" Oncology Instutute Medical Oncology Dept. Bari (Italy)
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades de las vías respiratorias
- Neoplasias
- Enfermedades pulmonares
- Neoplasias por sitio
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Neoplasias Pulmonares
- Carcinoma de pulmón de células no pequeñas
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de la síntesis de ácidos nucleicos
- Inhibidores de enzimas
- Agentes antineoplásicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Agentes antineoplásicos, fitogénicos
- Agentes antineoplásicos inmunológicos
- Inhibidores de la angiogénesis
- Agentes moduladores de la angiogénesis
- Sustancias de crecimiento
- Inhibidores del crecimiento
- Antagonistas del ácido fólico
- Carboplatino
- Paclitaxel
- Bevacizumab
- Pemetrexed
Otros números de identificación del estudio
- Goim 2903
- 2009-015807-19 (Número EudraCT)
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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