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Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer And Lung Dysfunction

12. juli 2016 opdateret af: Alliance for Clinical Trials in Oncology

Accelerated Conformal Radiotherapy for Stage I Non-Small Cell Lung Cancer in Patients With Pulmonary Dysfunction: A Phase I Study

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: Phase I trial to study the effectiveness of specialized high-dose radiation therapy in treating patients who have stage I non-small cell lung cancer and lung dysfunction.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

  • Determine the maximum tolerated course of accelerated 3-dimensional conformal radiotherapy in patients with stage I non-small cell lung cancer with pulmonary dysfunction.
  • Determine the short-term and long-term toxicity of this regimen in these patients.
  • Determine local tumor control, failure-free survival, and overall survival in patients treated with this regimen.
  • Determine the effect of radiotherapy dose volume relationships and pre-treatment pulmonary function studies on the incidence of pulmonary toxicity in these patients.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive accelerated 3-dimensional (3-D) conformal radiotherapy daily 5 days a week for 3.5-6 weeks.

Cohorts of 8 patients receive escalating fractions of accelerated 3-D conformal radiotherapy until the maximum tolerated course is determined. The maximum tolerated course is defined as the course at which no more than 2 patients develop at least grade 3 dose-limiting toxicity and no more than 1 patient develops at least grade 4 dose-limiting toxicity.

Patients are followed at 3 weeks, 6 weeks, 3 months, every 3 months for 2 years, and then every 6 months for 3 years.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

39

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Florida
      • Fort Lauderdale, Florida, Forenede Stater, 33308
        • Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
      • Hollywood, Florida, Forenede Stater, 33021
        • Memorial Cancer Institute at Memorial Regional Hospital
      • Jupiter, Florida, Forenede Stater, 33458
        • Ella Milbank Foshay Cancer Center at Jupiter Medical Center
      • Miami Beach, Florida, Forenede Stater, 33140
        • CCOP - Mount Sinai Medical Center
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637-1470
        • University of Chicago Cancer Research Center
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • Fairview University Medical Center - University Campus
    • Missouri
      • Chesterfield, Missouri, Forenede Stater, 63017
        • Saint Luke's Hospital
    • Nebraska
      • Grand Island, Nebraska, Forenede Stater, 68803
        • Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
      • North Platte, Nebraska, Forenede Stater, 69103
        • Great Plains Regional Medical Center
      • Omaha, Nebraska, Forenede Stater, 68198
        • UNMC Eppley Cancer Center at the University of Nebraska Medical Center
    • New York
      • Buffalo, New York, Forenede Stater, 14215
        • Veterans Affairs Medical Center - Buffalo
      • Oswego, New York, Forenede Stater, 13126
        • Oswego Hospital
      • Syracuse, New York, Forenede Stater, 13210
        • SUNY Upstate Medical University Hospital
      • Syracuse, New York, Forenede Stater, 13057
        • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
      • Syracuse, New York, Forenede Stater, 13203
        • St. Joseph's Hospital Health Center - Syracuse
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28203
        • Blumenthal Cancer Center at Carolinas Medical Center
      • Goldsboro, North Carolina, Forenede Stater, 27534
        • Wayne Memorial Hospital, Incorporated
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • Comprehensive Cancer Center at Wake Forest University
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43210
        • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15224-1791
        • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed stage I (T1-2, N0) non-small cell lung cancer (NSCLC)

    • Squamous cell carcinoma
    • Basaloid carcinoma
    • Adenocarcinoma
    • Bronchoalveolar carcinoma
    • Adenosquamous carcinoma
    • Large cell carcinoma
    • Large cell neuroendocrine carcinoma
    • Giant cell carcinoma
    • Sarcomatoid carcinoma
    • Non-small cell carcinoma not otherwise specified
  • Tridimensionally measurable solitary parenchymal lung lesion no greater than 4 cm in diameter by chest CT scan (lung windows)

  • No metastatic disease or hilar or mediastinal lymphadenopathy

    • Must have mediastinoscopy* (anterior, cervical, or both) if mediastinal lymph nodes are greater than 1.0 cm in diameter by chest CT scan

      • No positive lymph nodes on mediastinoscopy* NOTE: *Patients may have positron-emission tomography in lieu of mediastinoscopy provided there is no fludeoxyglucose F 18 uptake in the mediastinum and hilum

  • Poor surgical risk, as defined by 1 of the following:

    • High risk due to nonpulmonary reasons, such as renal failure, cardiac failure, or hepatic dysfunction and deemed by thoracic surgeon to be unsuitable for lobectomy

    • Pulmonary dysfunction indicated by one or more of the following:

      • FEV_1 less than 40% of predicted
      • DLCO less than 50% of predicted
      • Oxygen dependent
      • Chronic PaCO_2 greater than 45 mm Hg
      • VO_2 less than 15 mL/kg/min

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • 0-2

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No weight loss of more than 10% within the past 6 months
  • No other active (less than 30% risk of relapse after completion of prior therapy) malignancy except nonmelanoma skin cancer

Chemotherapy:

  • No prior chemotherapy for NSCLC

Radiotherapy:

  • No prior chest radiotherapy

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Radiotherapy

Patients receive accelerated 3-dimensional (3-D) conformal radiotherapy daily 5 days a week for 3.5-6 weeks.

Cohorts of 8 patients receive escalating fractions of accelerated 3-D conformal radiotherapy until the maximum tolerated course is determined. The maximum tolerated course is defined as the course at which no more than 2 patients develop at least grade 3 dose-limiting toxicity and no more than 1 patient develops at least grade 4 dose-limiting toxicity.

Patients are followed at 3 weeks, 6 weeks, 3 months, every 3 months for 2 years, and then every 6 months for 3 years.
Stråling: accelerated conformational radiotherapy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Samlet overlevelse
Tidsramme: Op til 5 år
Op til 5 år
Fejlfri overlevelse
Tidsramme: Op til 5 år
Op til 5 år

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Alliance for Clinical Trials in Oncology

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Studiestol: Jeffrey Bogart, MD, State University of New York - Upstate Medical University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2000

Primær færdiggørelse (Faktiske)

1. juni 2007

Studieafslutning (Faktiske)

1. juni 2010

Datoer for studieregistrering

Først indsendt

2. februar 2001

Først indsendt, der opfyldte QC-kriterier

4. juni 2003

Først opslået (Skøn)

5. juni 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

14. juli 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juli 2016

Sidst verificeret

1. juli 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CALGB-39904
  • U10CA076001 (U.S. NIH-bevilling/kontrakt)
  • CDR0000068409 (Registry Identifier: NCI Physician Data Query)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Lungekræft

Kliniske forsøg med accelerated conformational radiotherapy

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in United Kingdom

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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