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

4. oktober 2019 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

224

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Arm I
Patients undergo open or thoracoscopic sublobar resection comprising either a wedge resection or anatomical segmentectomy.
Fremgangsmåte: kirurgi
Eksperimentell: Arm II
Patients undergo surgery as in arm I. Patients also undergo intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
Fremgangsmåte: kirurgi
Stråling: brakyterapi

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to Local Recurrence
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Survival (OS)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 90 days
90 days
Number of Participants Reported Grade 3+ Adverse Events Within 90 Days After Sublobar Resection
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Alliance for Clinical Trials in Oncology

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

  • Studiestol: Hiran C. Fernando, MD, Boston Medical Center

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juli 2005

Primær fullføring (Faktiske)

18. april 2013

Studiet fullført (Faktiske)

15. februar 2019

Datoer for studieregistrering

Først innsendt

5. april 2005

Først innsendt som oppfylte QC-kriteriene

5. april 2005

Først lagt ut (Anslag)

6. april 2005

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. oktober 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. oktober 2019

Sist bekreftet

1. oktober 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ACOSOG-Z4032
  • CDR0000422346 (Registeridentifikator: NCI Physician Data Query)

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