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Chemotherapy Plus Radiation Therapy With or Without Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer

14 de novembro de 2015 atualizado por: Radiation Therapy Oncology Group

A Phase III Comparison Between Concurrent Chemotherapy Plus Radiotherapy and Concurrent Chemotherapy Plus Radiotherapy Followed by Surgical Resection for Stage IIIA (N2) Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known if chemotherapy plus radiation therapy is more effective with or without surgery for lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combining cisplatin, etoposide, and radiation therapy with or without surgery in treating patients who have stage IIIA non-small cell lung cancer.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

OBJECTIVES:

Primary

  • Compare the progression-free survival, median (2-year) survival, and long-term (5-year) survival in patients with newly diagnosed, stage IIIA (N2) non-small cell lung cancer treated with radiotherapy concurrently with cisplatin and etoposide with or without surgical resection.

Secondary

  • Compare the patterns of local and distant failure in patients treated with these regimens.
  • Determine the relationship of tobacco use, alcohol use, and diet with toxicity of these regimens and outcome in both men and women.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by contralateral mediastinal sampling or biopsy (yes vs no), tumor stage (T1 vs T2 vs T3), and performance status (70-80% vs 90-100%). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive induction with cisplatin IV over 1 hour on days 1 and 8 and etoposide IV over 1 hour on days 1-5. Treatment continues every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning within 24 hours of the first dose of chemotherapy, patients undergo induction radiotherapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity. Patients without local progression or distant metastases at 2-4 weeks after completion of course 2 undergo resection approximately 3-5 weeks after completion of course 2. All visible, accessible bronchopulmonary, hilar, and mediastinal lymph nodes are excised. The choice of surgical procedure (thoracotomy, lobectomy, or pneumonectomy with en bloc resection of tumor extending into the parietal pleura, chest wall, pericardium, or diaphragm) is at the discretion of the surgeon. Patients who undergo resection receive 2 additional courses of chemotherapy alone beginning 4-6 weeks postoperatively. Patients with unresectable disease or who are medically unfit for or refuse resection receive 2 additional courses of chemotherapy alone beginning immediately after completion of course 2.
  • Arm II: Patients undergo induction chemoradiotherapy as in arm I but do not undergo resection. Patients without local progression or distant metastases within 1 week before anticipated completion of induction radiotherapy receive 2 additional courses of chemotherapy beginning immediately after completion of course 2. Patients without local or distant progression after completion of course 4 undergo boost radiotherapy for 8 days.

Patients are followed every 2 months for 1 year, every 3 months for 2 years, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 510 patients will be accrued for this study within 4.9 years.

Tipo de estudo

Intervencional

Inscrição (Real)

429

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
    • Illinois
      • Urbana, Illinois, Estados Unidos, 61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46202-5289
        • Indiana University Cancer Center
      • Indianapolis, Indiana, Estados Unidos, 46202
        • Veterans Affairs Medical Center - Indianapolis (Roudebush)
    • Iowa
      • Cedar Rapids, Iowa, Estados Unidos, 52403-1206
        • CCOP - Cedar Rapids Oncology Project
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48106
        • CCOP - Ann Arbor Regional
    • Nebraska
      • Omaha, Nebraska, Estados Unidos, 68106
        • CCOP - Missouri Valley Cancer Consortium
    • New York
      • Rochester, New York, Estados Unidos, 14642
        • University of Rochester Cancer Center
    • Ohio
      • Cleveland, Ohio, Estados Unidos, 44106-5065
        • Ireland Cancer Center
      • Toledo, Ohio, Estados Unidos, 43623-3456
        • CCOP - Toledo Community Hospital Oncology Program
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19102-1192
        • Hahnemann University Hospital
      • Pittsburgh, Pennsylvania, Estados Unidos, 15213-3489
        • University of Pittsburgh Cancer Institute
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37232-6838
        • Vanderbilt-Ingram Cancer Center
    • Wisconsin
      • Green Bay, Wisconsin, Estados Unidos, 54301
        • CCOP - Green Bay
      • Milwaukee, Wisconsin, Estados Unidos, 53226
        • Medical College of Wisconsin
      • Milwaukee, Wisconsin, Estados Unidos, 53295
        • Veterans Affairs Medical Center - Milwaukee (Zablocki)
  • África do Sul
      • Pretoria, África do Sul, 0001
        • Pretoria Academic Hospitals

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 or cytologically proven newly diagnosed, stage IIIA (T1-3, N2) non-small cell lung cancer

    • Eligible subtypes:

      • Adenocarcinoma
      • Large cell carcinoma
      • Squamous cell carcinoma
      • Nonlobar and nondiffuse bronchoalveolar cell carcinoma

  • Measurable or evaluable disease on chest x-ray and/or contrast CT scan

    • Contrast thoracic CT required to complete staging
  • Single primary bronchogenic tumor (no more than 1 parenchymal lung lesion)

  • Pleural effusions allowed if 1 of the following conditions is met:

    • Negative cytology on thoracentesis if effusions present before mediastinoscopy or exploratory thoracotomy
    • Effusion seen on CT scan but not on chest x-ray and deemed too small to tap under CT or ultrasound guidance

  • Positive ipsilateral mediastinal node(s) with or without positive ipsilateral hilar nodes

    • Mediastinal nodes separate from primary lesion on CT scan or surgical exploration
    • Histologic or cytologic proof of N2 disease by thoracotomy, mediastinoscopy, mediastinotomy, Chamberlain procedure, Wang needle, or fine needle aspiration under bronchoscopic or CT guidance

    • Nodal biopsy or aspiration waived if all of the following conditions are met:

      • Paralyzed left true vocal cord documented by bronchoscopy or indirect laryngoscopy
      • Nodes visible in Level 5 region on CT scan
      • Distinct primary lesion separate from nodes on CT scan
    • All mediastinal nodal involvement mapped (positive or negative)

  • No positive nodes in contralateral mediastinum (supraclavicular areas and higher) and neck

    • Mediastinoscopy, mediastinotomy, Chamberlain procedure, or thoracotomy required for nodes larger than 1 cm on contrast CT scan
    • Surgery waived if nodes negative or no larger than 1 cm on CT scan
  • Lymphadenopathy allowed if biopsy proof of a benign cause
  • No metastases by contrast CT or MRI scan of the brain, bone scan, CT scan of the lungs to exclude other ipsilateral or contralateral parenchymal lesions, and contrast CT scan of the upper abdomen including entire liver and adrenals
  • No hepatomegaly or splenomegaly by physical examination or CT scan unless documentation of a benign cause
  • No pericardial effusion
  • No superior vena cava syndrome
  • No prior diagnosis of lung cancer

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 90-100% (70-80% allowed if albumin at least 0.85 times lower limit of normal and weight loss no greater than 10% within 3 months before diagnosis)

Hematopoietic:

  • White blood cell count (WBC) at least 4,000/mm^3 OR
  • Granulocyte count at least 2,000/mm^3
  • Platelet count normal
  • Hemoglobin at least 10.0 g/dL (less than 8.5 g/dL allowed if no marrow involvement with tumor)

Hepatic:

  • See Performance status
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)*
  • Serum glutamate oxaloacetate transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) no greater than 1.5 times ULN* NOTE: * Unless documentation of a benign cause

Renal:

  • Creatinine clearance at least 50 mL/min

Cardiovascular:

  • No myocardial infarction within the past 3 months
  • No active angina
  • No unstable arrhythmia
  • No congestive heart failure

Pulmonary:

  • Forced expiratory volume at one second (FEV1) at least 2.0 liters OR
  • Predicted postresection FEV1 at least 800 mL based on quantitative V/Q scan
  • Diffusion capacity of lung for carbon monoxide (DLCO) at least 50% predicted (corrected for hemoglobin) if pneumonectomy planned or likely after induction chemotherapy

Other:

  • No clinically significant hearing loss unless willing to accept the potential of further loss
  • No symptomatic peripheral neuropathy
  • No peptic ulcer disease under active treatment
  • No other medical illness not controllable by appropriate medical therapy
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or ductal or lobular carcinoma in situ of the breast
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent colony-stimulating factors

Chemotherapy:

  • No prior chemotherapy for lung cancer
  • No concurrent chemotherapy for another condition (such as arthritis)

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy for lung cancer

Surgery:

  • See Disease Characteristics
  • No prior resection of primary tumor

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
Experimental: RT + chemotherapy followed by surgery + chemotherapy
Induction radiation therapy (RT) + concurrent induction chemotherapy followed by surgery and additional chemotherapy
Radiação: radioterapia
Medicamento: etoposido
Medicamento: cisplatina
Procedimento: cirurgia convencional
Comparador Ativo: RT + chemotherapy followed by chemotherapy + RT
Induction RT + concurrent induction chemotherapy followed by additional chemotherapy + RT
Radiação: radioterapia
Medicamento: etoposido
Medicamento: cisplatina

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Median overall survival
Prazo: From randomization to date of death or last follow-up. Analysis occurs after patients have been potentially followed for 2.5 years.
From randomization to date of death or last follow-up. Analysis occurs after patients have been potentially followed for 2.5 years.

Medidas de resultados secundários

Medida de resultado
Prazo
Median Progression-free survival
Prazo: From randomization to date of death or last follow-up. Analysis occurs after patients have been potentially followed for 2.5 years.
From randomization to date of death or last follow-up. Analysis occurs after patients have been potentially followed for 2.5 years.
Patterns of local and distant failure
Prazo: From randomization to date of failure (local, regional or distant progression). Analysis occurs after patients have been potentially followed for 2.5 years.
From randomization to date of failure (local, regional or distant progression). Analysis occurs after patients have been potentially followed for 2.5 years.

Colaboradores e Investigadores

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

Patrocinador

Radiation Therapy Oncology Group

Colaboradores

National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
NCIC Clinical Trials Group
Southwest Oncology Group
Cancer and Leukemia Group B
North Central Cancer Treatment Group

Investigadores

  • Cadeira de estudo: Robert C. Miller, MD, Mayo Clinic
  • Cadeira de estudo: David S. Ettinger, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Cadeira de estudo: David H. Johnson, MD, Vanderbilt-Ingram Cancer Center
  • Investigador principal: Kathy S. Albain, MD, Loyola University
  • Cadeira de estudo: Bruce E. Johnson, MD, Dana-Farber Cancer Institute
  • Cadeira de estudo: Mark R. Green, MD, Medical University of South Carolina
  • Cadeira de estudo: Yvon Cormier, MD, L'Hopital Laval

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

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 março de 1994

Conclusão Primária (Real)

1 de junho de 2004

Conclusão do estudo (Real)

1 de novembro de 2013

Datas de inscrição no estudo

Enviado pela primeira vez

1 de novembro de 1999

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de abril de 2003

Primeira postagem (Estimativa)

10 de abril de 2003

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

17 de novembro de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

14 de novembro de 2015

Última verificação

1 de novembro de 2015

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • RTOG-9309
  • CDR0000063333
  • CAN-NCIC-BR13
  • CLB-9592
  • E-R9309
  • NCCTG-R9309
  • NCI-94-C-0043
  • SWOG-9336
  • INT-0139

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 .

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