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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 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Werkelijk)

224

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Arm I
Patients undergo open or thoracoscopic sublobar resection comprising either a wedge resection or anatomical segmentectomy.
Procedure: chirurgie
Experimenteel: Arm II
Patients undergo surgery as in arm I. Patients also undergo intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
Procedure: chirurgie
Straling: brachytherapie

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time to Local Recurrence
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall Survival (OS)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 90 days
90 days
Number of Participants Reported Grade 3+ Adverse Events Within 90 Days After Sublobar Resection
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Alliance for Clinical Trials in Oncology

Medewerkers

National Cancer Institute (NCI)

Onderzoekers

  • Studie stoel: Hiran C. Fernando, MD, Boston Medical Center

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 juli 2005

Primaire voltooiing (Werkelijk)

18 april 2013

Studie voltooiing (Werkelijk)

15 februari 2019

Studieregistratiedata

Eerst ingediend

5 april 2005

Eerst ingediend dat voldeed aan de QC-criteria

5 april 2005

Eerst geplaatst (Schatting)

6 april 2005

Updates van studierecords

Laatste update geplaatst (Werkelijk)

18 oktober 2019

Laatste update ingediend die voldeed aan QC-criteria

4 oktober 2019

Laatst geverifieerd

1 oktober 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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