Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Radiation Therapy Cisplatin With or Without Fluorouracil Patients With Stage III or Stage IV Head and Neck Cancer

23 de julho de 2020 atualizado por: Case Comprehensive Cancer Center

A Phase III Randomized Trial Comparing Single Agent Cisplatin With the Combination of 5-Fluorouracil and Cisplatin, Concurrent With Radiation Therapy in Stage III and IV Squamous Cell Head and Neck Cancer

RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with cisplatin and fluorouracil may kill more tumor cells. It is not yet known whether radiation therapy and cisplatin are more effective with or without fluorouracil in treating patients with head and neck cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy and cisplatin to compare how well they work with or without fluorouracil in treating patients with stage III or stage IV head and neck cancer.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

OBJECTIVES:

  • To compare the relapse-free survival of patients treated with radiotherapy and cisplatin with vs without fluorouracil.
  • To compare the overall survival, local control without surgery, and patterns of failure in patients treated with these regimens.
  • To compare the acute and long-term toxicity of these regimens in these patients.
  • To compare the quality of life of patients treated with these regimens.
  • To prospectively collect biopsy material, mucosal scrapings, and serum in an effort to generate hypotheses for future correlative studies.

OUTLINE: This is a multicenter study. Patients are stratified according to radiotherapy schedule (once daily vs twice daily) and radiotherapy planning (2D vs 3D vs intensity-modulated radiotherapy). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
  • Arm II: Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.

Patients with biopsy-verified residual disease at the primary site or local recurrence after achieving a complete response to chemoradiotherapy may undergo salvage surgery 12 weeks after the completion of chemoradiotherapy.

Patients complete questionnaires periodically to assess late toxicity and quality of life.

After completion of study treatment, patients are followed periodically.

Tipo de estudo

Intervencional

Inscrição (Real)

69

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Ohio
      • Cleveland, Ohio, Estados Unidos, 44195
        • Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
      • Cleveland, Ohio, Estados Unidos, 44106-5065
        • Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

DISEASE CHARACTERISTICS:

  • Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx

    • No histologic diagnosis other than squamous cell carcinoma
    • A primary site must be identified

  • Must have locoregionally confined stage III (excluding T1-2, N1) or stage IV disease

    • No evidence of nodal disease below the clavicles or distant hematogenous metastases (M0)
    • No stage IVC disease (stage IVB disease allowed)

  • Deemed appropriate for definitive non-operative management with curative intent

    • Resectable disease is not required
  • No primary cancer of the nasopharynx, paranasal sinus, or salivary gland

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • WBC > 3,500/mm³
  • Platelet count > 100,000/mm³
  • Serum creatinine < 2.0 mg/dL
  • Alkaline phosphatase < 2 times normal
  • AST < 2 times normal
  • Bilirubin ≤ 2.0 mg/dL
  • Serum calcium normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No unstable or uncontrolled angina
  • No clinically apparent jaundice
  • No active infection
  • No history of any other malignancy (except squamous cell or basal cell skin cancer or cervical carcinoma in situ), unless the patient has been continuously disease-free for at least 5 years
  • Not a poor compliance risk
  • Able to withstand the rigors of intensive treatment
  • Available for and compliant with adequate long-term follow-up

PRIOR CONCURRENT THERAPY:

  • No prior definitive surgery or radiotherapy for this malignancy
  • No prior chemotherapy, immunotherapy, or epidermal growth factor receptor inhibitors for any disease Patients who have had previous definitive surgery, or radiation therapy for this malignancy, and patients who have had any previous chemotherapy, immunotherapy, or EGF receptor inhibition for any disease are ineligible.

Exclusion Criteria Patients with primary cancers of the nasopharynx, paranasal sinus or salivary gland are ineligible.

Patients with unstable or uncontrolled angina, clinically apparent jaundice, or active infection are ineligible.

Patients with a history of any other malignancy (except squamous or basal cell skin cancer or cervical carcinoma in-situ) are ineligible, unless the patient has been continuously disease-free for at least 5 years.

Patients with any histologic diagnosis other than squamous cell carcinoma are ineligible.

Patients who might be a poor-compliance risk are ineligible.

Pregnant or breastfeeding women are ineligible. Women/men of reproductive potential must be willing to practice acceptable methods of birth control to prevent pregnancy.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Arm A: Radiation with concurrent Cisplatin
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Medicamento: cisplatina
Dado IV
Outros nomes:
  • CDDP
Radiação: radiation therapy
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks
Outros nomes:
  • radiação
Experimental: Arm B: Radiation with concurrent 5-FU and Cisplatin
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Medicamento: fluorouracil
Dado IV
Medicamento: cisplatina
Dado IV
Outros nomes:
  • CDDP
Radiação: radiation therapy
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks
Outros nomes:
  • radiação

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Relapse Free Survival
Prazo: at 2 yrs from start of study
Number of patients that are alive without recurrence when recurrence is defined by any subject with new evidence of cancer after achieving a complete response. Complete response is defined by the complete disappearance of all clinically and radiologically detectable tumor..
at 2 yrs from start of study

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Patterns of Failure
Prazo: 2 years from start of study
Patients with any new evidence of cancer after achieving a complete response are considered to have recurrent disease. Biopsy verification will be obtained if at all possible and salvage surgery is recommended if possible. Disease recurrence will be characterized as either local, regional(nodal) or distant recurrence. Patients may have more than one kind of recurrence.
2 years from start of study
Overall Survival
Prazo: 2 yrs from start of study
Number of patients still alive from 2 years from start of study
2 yrs from start of study
Number of Patients With a Clinical Response-complete Disappearance of Detectable Tumor
Prazo: at 12 weeks after completing chemoradiotherapy
Twelve weeks after completing chemoradiotherapy, a formal evaluation for response will be made, to include a careful evaluation by the head and neck surgeon, medical and radiation oncologists, and, as appropriate, a radiologic and an endoscopic examination. Patients will be considered to have achieved either a clinical complete response (i.e. complete disappearance of all clinically and radiologically detectable tumor) or to have clinical persistent disease.
at 12 weeks after completing chemoradiotherapy
Number of Patients With a Pathological(Final)Complete Response
Prazo: at 12 weeks after completing chemoradiotherapy and surgery
A Pathological, or final response will be assigned to subjects after any salvage surgery is performed for clinical persistent disease, and after planned neck dissection in those achieving a clinical complete response. If no surgery is performed after chemoradiotherapy, the clinical and pathological (final) response will be the same. Patient will be coded as having either a pathologic complete response, or as having pathologic persistent disease. A pathologic complete response will be defined as the total disappearance of all clinically and radiologically detectable tumor.
at 12 weeks after completing chemoradiotherapy and surgery
Disease Recurrence
Prazo: 2 years after start of study
Number of patients with any new evidence of cancer after achieving a complete response (at 12 weeks after completing chemoradiotherapy) are considered to have recurrent disease.
2 years after start of study
Number of Patients That Required a Feeding Tube
Prazo: 12 weeks (after treatment)
12 weeks (after treatment)
Number of Patients That Required a Feeding Tube
Prazo: 8 months after start of treatment
8 months after start of treatment
Number of Patients That Required a Feeding Tube
Prazo: 12 months after start of treatment
12 months after start of treatment
Number of Patients That Required a Feeding Tube
Prazo: 24 months after start of treatment
24 months after start of treatment
Nausea Level
Prazo: 12 weeks (after treatment)

Quality of life questionnaire asking "I have nausea".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4).

N (number of patients analyzed) is based on number of patients who completed the question.
12 weeks (after treatment)
Nausea Level
Prazo: 8 months from start of treatment

Quality of life questionnaire asking "I have nausea".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
8 months from start of treatment
Nausea Level
Prazo: 12 months from start of treatment

Quality of life questionnaire asking "I have nausea".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
12 months from start of treatment
Nausea Level
Prazo: 24 months from start of treatment
Quality of life questionnaire asking "I have nausea".
24 months from start of treatment
Dry Mouth
Prazo: 12 weeks (after treatment)

Quality of life questionnaire asking "My mouth is dry".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
12 weeks (after treatment)
Dry Mouth
Prazo: 8 months from start of treatment

Quality of life questionnaire asking "My mouth is dry".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
8 months from start of treatment
Dry Mouth
Prazo: 12 months from start of treatment

Quality of life questionnaire asking "My mouth is dry".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
12 months from start of treatment
Dry Mouth
Prazo: 24 months from start of treatment

Quality of life questionnaire asking "My mouth is dry".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
24 months from start of treatment
Pain
Prazo: 12 weeks (after treatment)

Quality of life questionnaire asking "I have pain in my mouth, throat or neck".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
12 weeks (after treatment)
Pain
Prazo: 8 months from start of treatment

Quality of life questionnaire asking "I have pain in my mouth, throat or neck".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
8 months from start of treatment
Pain
Prazo: 12 months from start of treatment

Quality of life questionnaire asking "I have pain in my mouth, throat or neck".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
12 months from start of treatment
Pain
Prazo: 24 months from start of treatment

Quality of life questionnaire asking "I have pain in my mouth, throat or neck".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
24 months from start of treatment
Quality of Life
Prazo: 12 weeks (after treatment)

Quality of life questionnaire asking "I am content with the quality of my life right now".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
12 weeks (after treatment)
Quality of Life
Prazo: 8 months from start of treatment

Quality of life questionnaire asking "I am content with the quality of my life right now".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
8 months from start of treatment
Quality of Life
Prazo: 12 months from start of treatment

Quality of life questionnaire asking "I am content with the quality of my life right now".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
12 months from start of treatment
Quality of Life
Prazo: 24 months from start of treatment

Quality of life questionnaire asking "I am content with the quality of my life right now".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
24 months from start of treatment
Eating
Prazo: 12 weeks (after treatment)

Quality of life questionnaire asking "I am able to eat the foods i like".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
12 weeks (after treatment)
Eating
Prazo: 8 months from start of treatment

Quality of life questionnaire asking "I am able to eat the foods i like".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
8 months from start of treatment
Eating
Prazo: 12 months from start of treatment

Quality of life questionnaire asking "I am able to eat the foods i like".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
12 months from start of treatment
Eating
Prazo: 24 months from start of treatment

Quality of life questionnaire asking "I am able to eat the foods i like".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
24 months from start of treatment
Swallowing
Prazo: 12 weeks (after treatment)

Quality of life questionnaire asking "I can swallow naturally and easily".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
12 weeks (after treatment)
Swallowing
Prazo: 8 months after start of treatment

Quality of life questionnaire asking "I can swallow naturally and easily".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
8 months after start of treatment
Swallowing
Prazo: 12 months after start of treatment

Quality of life questionnaire asking "I can swallow naturally and easily".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
12 months after start of treatment
Swallowing
Prazo: 24 months after start of treatment

Quality of life questionnaire asking "I can swallow naturally and easily".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
24 months after start of treatment
Alcohol Consumption
Prazo: 12 weeks (after treatment)

Quality of life questionnaire asking "I drink alcohol (e.g. beer, wine)".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
12 weeks (after treatment)
Alcohol Consumption
Prazo: 8 months after start of treatment

Quality of life questionnaire asking "I drink alcohol (e.g. beer, wine)".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
8 months after start of treatment
Alcohol Consumption
Prazo: 12 months after start of treatment

Quality of life questionnaire asking "I drink alcohol (e.g. beer, wine)".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
12 months after start of treatment
Alcohol Consumption
Prazo: 24 months after start of treatment

Quality of life questionnaire asking "I drink alcohol (e.g. beer, wine)".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
24 months after start of treatment
Solid Foods
Prazo: 12 weeks (after treatment)

Quality of life questionnaire asking "I can eat solid foods".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
12 weeks (after treatment)
Solid Foods
Prazo: 8 months after start of treatment

Quality of life questionnaire asking "I can eat solid foods".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
8 months after start of treatment
Solid Foods
Prazo: 12 months after start of treatment

Quality of life questionnaire asking "I can eat solid foods".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
12 months after start of treatment
Solid Foods
Prazo: 24 months after start of treatment

Quality of life questionnaire asking "I can eat solid foods".

The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
24 months after start of treatment

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Case Comprehensive Cancer Center

Investigadores

  • Investigador principal: David J. Adelstein, MD, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de janeiro de 2008

Conclusão Primária (Real)

1 de setembro de 2012

Conclusão do estudo (Real)

1 de agosto de 2016

Datas de inscrição no estudo

Enviado pela primeira vez

30 de janeiro de 2008

Enviado pela primeira vez que atendeu aos critérios de CQ

31 de janeiro de 2008

Primeira postagem (Estimativa)

6 de fevereiro de 2008

Atualizações de registro de estudo

Última Atualização Postada (Real)

6 de agosto de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

23 de julho de 2020

Última verificação

1 de julho de 2020

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CASE3307
  • NCI-2010-01197 (Outro identificador: NCI/CTRP)

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 .

Ensaios clínicos em fluorouracil

Pesquisar ensaios semelhantes

Patrocinadores e Colaboradores

Condições médicas

Intervenções de drogas

CROs by country

CROs in Belgium

Condições

Doenças Raras

Intervenções de drogas

Suplementos Alimentares

Patrocinador / Colaboradores

Localizações

3
Se inscrever