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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 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

224

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Arm I
Patients undergo open or thoracoscopic sublobar resection comprising either a wedge resection or anatomical segmentectomy.
Procedur: kirurgi
Experimentell: Arm II
Patients undergo surgery as in arm I. Patients also undergo intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
Procedur: kirurgi
Strålning: brakyterapi

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Time to Local Recurrence
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall Survival (OS)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 90 days
90 days
Number of Participants Reported Grade 3+ Adverse Events Within 90 Days After Sublobar Resection
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Alliance for Clinical Trials in Oncology

Samarbetspartners

National Cancer Institute (NCI)

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juli 2005

Primärt slutförande (Faktisk)

18 april 2013

Avslutad studie (Faktisk)

15 februari 2019

Studieregistreringsdatum

Först inskickad

5 april 2005

Först inskickad som uppfyllde QC-kriterierna

5 april 2005

Första postat (Uppskatta)

6 april 2005

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 oktober 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 oktober 2019

Senast verifierad

1 oktober 2019

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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