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Surgery With or Without Internal Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer

4 ottobre 2019 aggiornato da: Alliance for Clinical Trials in Oncology

A Randomized Phase III Study of Sublobar Resection Versus Sublobar Resection Plus Brachytherapy in High Risk Patients With Non-Small Cell Lung Cancer (NSCLC), 3cm or Smaller

This randomized phase III trial studies surgery and internal radiation therapy to see how well they work compared to surgery alone in treating patients with stage I non-small cell lung cancer. Surgery may be an effective treatment for non-small cell lung cancer. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether surgery and internal radiation therapy are more effective than surgery alone in treating non-small cell lung cancer.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

PRIMARY OBJECTIVES:

I. To ascertain whether patients treated by sublobar resection (SR) + brachytherhapy (BX) have longer time to local recurrence as compared to the patients treated by SR (local recurrence includes recurrence within the same lobe or hilum [N1 nodes], or progression at the staple line after treatment effects such as scarring have subsided).

SECONDARY OBJECTIVES:

I. To compare procedure specific morbidity and mortality between study arms. II. To compare overall survival and failure-free survival between study arms. III. To assess freedom from regional or distant recurrence. IV. To assess the effect of histological or cytologic positive resection margins on time to local recurrence.

V. To determine the effect of brachytherapy on quality of life (QoL). VI. To determine the effect of brachytherapy on pulmonary function.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo open or thoracoscopic sublobar resection comprising either a wedge resection or anatomical segmentectomy.

ARM II: Patients undergo surgery as in arm I. Patients also undergo intraoperative brachytherapy comprising iodine I 125 implant at the resection margin.

After completion of study treatment, patients are followed at 3, 6, 12, 18, 24, 30, and 36 months and then yearly for 2 years.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

224

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

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Program at London Health Sciences Centre
  • Stati Uniti
    • Arizona
      • Scottsdale, Arizona, Stati Uniti, 85259-5499
        • Mayo Clinic Scottsdale
    • California
      • Sacramento, California, Stati Uniti, 95817
        • University of California Davis Cancer Center
    • Florida
      • Jacksonville, Florida, Stati Uniti, 32224
        • Mayo Clinic - Jacksonville
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30322
        • Winship Cancer Institute of Emory University
    • Illinois
      • Evanston, Illinois, Stati Uniti, 60201-1781
        • Evanston Hospital
      • Springfield, Illinois, Stati Uniti, 62781-0001
        • Regional Cancer Center at Memorial Medical Center
      • Springfield, Illinois, Stati Uniti, 62794-9677
        • Simmons Cooper Cancer Institute
      • Springfield, Illinois, Stati Uniti, 62702
        • Cancer Institute at St. John's Hospital
    • Maryland
      • Towson, Maryland, Stati Uniti, 21204
        • Cancer Institute at St. Joseph Medical Center
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02118
        • Boston University Cancer Research Center
    • Michigan
      • Ann Arbor, Michigan, Stati Uniti, 48109-0942
        • University of Michigan Comprehensive Cancer Center
    • Minnesota
      • Rochester, Minnesota, Stati Uniti, 55905
        • Mayo Clinic Cancer Center
    • Missouri
      • Saint Louis, Missouri, Stati Uniti, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
    • New Hampshire
      • Lebanon, New Hampshire, Stati Uniti, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Ridgewood, New Jersey, Stati Uniti, 07450
        • Valley Hospital - Ridgewood
    • New York
      • Oceanside, New York, Stati Uniti, 11572
        • South Nassau Communities Hospital
      • Rochester, New York, Stati Uniti, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
      • Syracuse, New York, Stati Uniti, 13210
        • SUNY Upstate Medical University Hospital
    • North Carolina
      • Charlotte, North Carolina, Stati Uniti, 28233-3549
        • Presbyterian Cancer Center at Presbyterian Hospital
    • Ohio
      • Cincinnati, Ohio, Stati Uniti, 45267
        • Charles M. Barrett Cancer Center at University Hospital
    • Oregon
      • Portland, Oregon, Stati Uniti, 97239-3098
        • Knight Cancer Institute At Oregon Health and Science University
    • Pennsylvania
      • New Castle, Pennsylvania, Stati Uniti, 16105
        • Jameson Memorial Hospital - North Campus
      • Philadelphia, Pennsylvania, Stati Uniti, 19111-2497
        • Fox Chase Cancer Center - Philadelphia
      • Philadelphia, Pennsylvania, Stati Uniti, 19104-4283
        • Abramson Cancer Center of the University of Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19107-5541
        • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
      • Pittsburgh, Pennsylvania, Stati Uniti, 15232
        • UPMC Cancer Centers
      • Pittsburgh, Pennsylvania, Stati Uniti, 15212
        • Allegheny Cancer Center at Allegheny General Hospital
      • Reading, Pennsylvania, Stati Uniti, 19612-6052
        • McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
    • Rhode Island
      • Providence, Rhode Island, Stati Uniti, 02906
        • Miriam Hospital
      • Providence, Rhode Island, Stati Uniti, 02903
        • Rhode Island Hospital Comprehensive Cancer Center
    • Tennessee
      • Knoxville, Tennessee, Stati Uniti, 37920-6999
        • U.T. Medical Center Cancer Institute
    • Texas
      • Houston, Texas, Stati Uniti, 77030
        • Methodist Hospital
    • Utah
      • Murray, Utah, Stati Uniti, 84157
        • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
    • Virginia
      • Charlottesville, Virginia, Stati Uniti, 22908
        • University of Virginia Cancer Center
    • Washington
      • Seattle, Washington, Stati Uniti, 98122-4307
        • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
      • Seattle, Washington, Stati Uniti, 98111
        • Floyd and Delores Jones Cancer Institute at Virginia Mason Medical Center
    • Wisconsin
      • Madison, Wisconsin, Stati Uniti, 53792-6164
        • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

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

Inclusion Criteria:

  • PART I: PRE-OPERATIVE CRITERIA (PRE-REGISTRATION/RANDOMIZATION)
  • Patients must have a suspicious lung nodule for clinical stage I non-small cell lung cancer (NSCLC)
  • Patient must have a mass =< 3 cm maximum diameter by computed tomography (CT) size estimate: clinical stage Ia or selected Ib (i.e., with visceral pleural involvement)
  • Patient must have a CT scan of the chest with upper abdomen within 60 days prior to date of pre-registration
  • Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status 0, 1, or 2

  • Patient must meet at least one major criteria or meet a minimum of two minor criteria as described below:

    • Major criteria

      • Forced expiratory volume in 1 second (FEV1) =< 50% predicted
      • Diffusing capacity of the lungs for carbon monoxide (DLCO) =< 50% predicted

    • Minor criteria

      • Age >= 75
      • FEV1 51-60% predicted
      • DLCO 51-60% predicted
      • Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40 mmHg) as estimated by echocardiography or right heart catheterization
      • Poor left ventricular function (defined as an ejection fraction of 40% or less)
      • Resting or exercise partial pressure of oxygen (pO2) =< 55 mm Hg or peripheral capillary oxygen saturation (SpO2) =< 88%
      • Partial pressure of carbon dioxide (pCO2) > 45 mm Hg
      • Modified Medical Research Council (MMRC) Dyspnea Scale >= 3
  • Patient must not have had previous intra-thoracic radiation therapy
  • Women of child-bearing potential must have negative serum or urine pregnancy test
  • No prior invasive malignancy, unless disease-free for >= 5 years prior to pre-registration (exceptions: non-melanoma skin cancer, in-situ cancers)
  • PART II: INTRA-OPERATIVE CRITERIA (REGISTRATION)
  • Patient must have biopsy-proven NSCLC
  • Patient must have all suspicious mediastinal lymph nodes (> 1 cm short-axis dimension on CT scan or positive on positron emission tomography [PET] scan) assessed by one of the following methods to confirm negative involvement with NSCLC (mediastinoscopy, endo-esophageal ultrasound guided needle aspiration, CT-guided, video-assisted thoracoscopic or open lymph node biopsy)

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
Comparatore attivo: Arm I
Patients undergo open or thoracoscopic sublobar resection comprising either a wedge resection or anatomical segmentectomy.
Procedura: chirurgia
Sperimentale: Arm II
Patients undergo surgery as in arm I. Patients also undergo intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
Procedura: chirurgia
Radiazione: brachiterapia

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to Local Recurrence
Lasso di tempo: Up to 3 years
Local recurrence included the recurrence within the same lobe or hilum (N1 nodes), or progression at the staple line after treatment effects such as scarring have subsided. Time to local recurrence was censored 1) at the time of a distant recurrence, 2) at the last follow-up time when a patient died within 3 years of randomization without a local recurrence or 3) at 3 years follow-up if the patient remains alive 3 years post-randomization without a local recurrence.
Up to 3 years

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival (OS)
Lasso di tempo: Up to 5 years
OS was defined as the time from randomization to death due to any cause.
Up to 5 years
Number of Participants Reported Local Recurrence at 3 Years
Lasso di tempo: 3 years
Local recurrence was defined as the recurrence within the same lobe or hilum (N1 nodes), or at the staple line after treatment effects such as scarring have subsided.
3 years
Number of Participants Reported Regional Recurrence at 3 Years
Lasso di tempo: 3 years
Regional recurrence was defined as the recurrence within another lobe or pleura on the same side as the resection, or the ipsilateral mediastinal (N2) nodes.
3 years
Number of Participants Reported Distant Recurrence at 3 Years
Lasso di tempo: 3 years
Distant recurrence was defined as the recurrence within contralateral lobe, contralateral mediastinal (N3) nodes or distant> metastatic disease (other organs).
3 years
Mortality Rates at 30- and 90-day After Sublobar Resection
Lasso di tempo: 90 days
90 days
Number of Participants Reported Grade 3+ Adverse Events Within 90 Days After Sublobar Resection
Lasso di tempo: 90 days
Adverse Events were assessed via the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.
90 days
Number of Participants Reported Grade 3+ Respiratory Adverse Events Within 90 Days After Sublobar Resection
Lasso di tempo: 90 days
The respiratory AE included adult respiratory distress syndrome, aspiration, bronchospasm, bronchostenosis, dyspnea, hypoxia, pleural effusion, pneumonitis, chest tube drainage or leak, prolonged intubation, pulmonary-other, and pneumonia as defined by the CTCAE version 3.0.
90 days
Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24
Lasso di tempo: 24 months
Short-form health survey (SF36) consist of 36 items, where scores can be reported as 8 domains of functional health and well-being, or transformed into a physical component summary (PCS) score and a mental component summary (MCS) score. Standardized scores of SF36 PCS and MCS scores were calculated using the mean, SD, and scoring coefficients from the US general population. The standardized scores were then adjusted for age and gender using the mean and SD of the US general population according to age and gender grouping, and employing a linear transformation. Scores <50 indicate below-average health status.
24 months
Dyspnea as Measured Using SOBQ at Baseline, Months 3, Months 12 and 24
Lasso di tempo: 24 months
Dyspnea was evaluated using the University of California, San Diego Shortness of Breath Questionnaire (SOBQ). It consists of 24-item on a scale of 0 to 5 with 0=not at all and 5=maximal or unable to do because of breathlessness. The total scores was calculated by summation of the 24 items scores and transformed into 0-100, with 0= poor quality of life , and 100= excellent quality of life..
24 months
FEV1% Measured at Baseline and Month 3
Lasso di tempo: 3 months
Pulmonary function tests included percentage predicted forced expiratory volume in 1 second (FEV1%) at baseline and month 3 were compared between arms
3 months
DLCO% Measured at Baseline and Month 3
Lasso di tempo: 3 months

Pulmonary function tests included percentage predicted carbon

> monoxide diffusing capacity of the lung (DLCO%) at baseline and month 3 were compared between arms.
3 months

Collaboratori e investigatori

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

Sponsor

Alliance for Clinical Trials in Oncology

Collaboratori

National Cancer Institute (NCI)

Investigatori

  • Cattedra di studio: Hiran C. Fernando, MD, Boston Medical Center

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 (Effettivo)

1 luglio 2005

Completamento primario (Effettivo)

18 aprile 2013

Completamento dello studio (Effettivo)

15 febbraio 2019

Date di iscrizione allo studio

Primo inviato

5 aprile 2005

Primo inviato che soddisfa i criteri di controllo qualità

5 aprile 2005

Primo Inserito (Stima)

6 aprile 2005

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 ottobre 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 ottobre 2019

Ultimo verificato

1 ottobre 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ACOSOG-Z4032
  • CDR0000422346 (Identificatore di registro: NCI Physician Data Query)

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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