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

14 novembre 2015 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

429

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: RT + chemotherapy followed by surgery + chemotherapy
Induction radiation therapy (RT) + concurrent induction chemotherapy followed by surgery and additional chemotherapy
Radiation: Radiothérapie
Médicament: étoposide
Médicament: cisplatine
Procédure: chirurgie conventionnelle
Comparateur actif: RT + chemotherapy followed by chemotherapy + RT
Induction RT + concurrent induction chemotherapy followed by additional chemotherapy + RT
Radiation: Radiothérapie
Médicament: étoposide
Médicament: cisplatine

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Median overall survival
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Délai
Median Progression-free survival
Délai: 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
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Radiation Therapy Oncology Group

Collaborateurs

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

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mars 1994

Achèvement primaire (Réel)

1 juin 2004

Achèvement de l'étude (Réel)

1 novembre 2013

Dates d'inscription aux études

Première soumission

1 novembre 1999

Première soumission répondant aux critères de contrôle qualité

9 avril 2003

Première publication (Estimation)

10 avril 2003

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

17 novembre 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 novembre 2015

Dernière vérification

1 novembre 2015

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

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

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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