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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 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

429

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: RT + chemotherapy followed by surgery + chemotherapy
Induction radiation therapy (RT) + concurrent induction chemotherapy followed by surgery and additional chemotherapy
Radiazione: radioterapia
Droga: etoposide
Droga: cisplatino
Procedura: chirurgia convenzionale
Comparatore attivo: RT + chemotherapy followed by chemotherapy + RT
Induction RT + concurrent induction chemotherapy followed by additional chemotherapy + RT
Radiazione: radioterapia
Droga: etoposide
Droga: cisplatino

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Median overall survival
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Median Progression-free survival
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Radiation Therapy Oncology Group

Collaboratori

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

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 1994

Completamento primario (Effettivo)

1 giugno 2004

Completamento dello studio (Effettivo)

1 novembre 2013

Date di iscrizione allo studio

Primo inviato

1 novembre 1999

Primo inviato che soddisfa i criteri di controllo qualità

9 aprile 2003

Primo Inserito (Stima)

10 aprile 2003

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

17 novembre 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 novembre 2015

Ultimo verificato

1 novembre 2015

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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