- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01820312
A Phase II Study to Evaluate Low-Dose Fractionated Radiotherapy (LDFRT)
A Phase II Study to Evaluate Low-Dose Fractionated Radiotherapy (LDFRT) and Chemotherapy in Recurrent and Inoperable Squamous Cell Carcinoma (SCC) of the Head and Neck After Radiotherapy Failure
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
This study will evaluate a combination therapy of paclitaxel and LDFRT. The paclitaxel will be commercially available drug product dispensed by a licensed pharmacist at UAMS. Radiotherapy will be delivered using either the TomoTherapy Treatment System (TomoTherapy, Inc.) or the Varian High Energy Linear Accelerator (Varian Medical Systems).
Subjects will undergo CT imaging (to include neck, chest, abdomen and pelvis) as part of the standard of care approximately 7 to 21 days prior to initiation of this therapy. Additional CT imaging will be done at UAMS approximately 3 months after completion of protocol therapy and every 3 months subsequently until progression or completion of the study whichever comes first. These CT imaging's will be obtained for recurrent tumor evaluation and determination of the presence or absence of distant metastasis, as part of the standard of care.
Tipo de estudo
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
-
-
Arkansas
-
Little Rick, Arkansas, Estados Unidos, 72205
- University of Arkansas for Medical Sciences
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Subject 18 years of age and older, male or female, of all races and ethnicities.
- Subject with prior histologically confirmed advanced squamous-cell carcinoma of the head and neck that failed prior traditional chemoradiotherapy with at least a 3-month disease-free interval from the completion of the initial curative treatment.
- Recurrence must have been confirmed via biopsy.
- Subject must have an ECOG performance status of 0, 1 or 2.
- Has undergone CT imaging within 21 days prior to treatment as part of routine care.
- Measurable disease by CT.
- Subject deemed likely to survive for at least 6 months.
- Subject is able and willing to provide written informed consent to participate in the study.
- If the subject is a female of childbearing age, the subject should have a negative urine pregnancy test and be practicing strict birth control (estrogen-containing oral contraceptives or an intrauterine device) throughout the study and for 3 months after completion of protocol treatment. Women who have had a hysterectomy are exempt from these requirements. This is routine for any patient undergoing treatment.
- History of laboratory criteria as specified below (within 21 days prior to enrollment) Hemoglobin ≥ 9 g/dl Platelet count >100,000 per microliter CO2 (carbon dioxide): 22-32 meq/L Creatinine: < 1.5 mg/dL or eGFR>40 ml/min Serum bilirubin <1.6 mg/dl. White blood count > 3,000 per microliter or ANC > 1500 per microliter Serum calcium <10.5 mg/dl.
Exclusion Criteria:
- The tumor is not clearly shown on diagnostic imaging studies
- Subject is pregnant.
- Subject with known allergies/hypersensitivity to paclitaxel.
- Subjects with poor renal function as demonstrated by serum creatinine (>1.5 mg/dl) and EGFR <40 mL/min, which would preclude the using of image contrast agents.
- Subject with a planned surgical procedure within the next 30 days.
- Subject has distant metastasis (with the exception of single stable distant metastasis that does not decrease life expectancy to less than 6 months).
- Subject is of childbearing potential and will not use adequate contraceptive protection.
- Subject who is breastfeeding.
- Subject of childbearing potential who has a positive (+) urine pregnancy test.
- Subject has received treatment with an experimental drug or entered another clinical trial within the prior 30 days.
- Subject has received radiotherapy to the head and neck region within the prior 3 months.
- Subject is not willing or able to complete the visit requirements of this protocol.
- Peripheral neuropathy of any etiology.
- Any other condition that the PI feels will be an endangerment to the subject.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Objective Response (OR)
Prazo: OR will be determined in each subject 3 months following therapy using CT imaging performed for clinical-care purposes
|
Objective Response (OR).
OR will be defined according to RECIST v1.1 criteria as either a complete or partial response.
OR will be determined in each subject 3 months following therapy using CT imaging performed for clinical-care purposes.
|
OR will be determined in each subject 3 months following therapy using CT imaging performed for clinical-care purposes
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jose Penagaricano, MD, University of Arkansas
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Neoplasias por Tipo Histológico
- Neoplasias
- Neoplasias por local
- Neoplasias Glandulares e Epiteliais
- Neoplasias de Cabeça e Pescoço
- Neoplasias de Células Escamosas
- Carcinoma
- Carcinoma de Células Escamosas
- Carcinoma Espinocelular de Cabeça e Pescoço
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Antineoplásicos
- Moduladores de Tubulina
- Agentes Antimitóticos
- Moduladores de Mitose
- Agentes Antineoplásicos Fitogênicos
- Paclitaxel
Outros números de identificação do estudo
- 136191
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .