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Radiofrequency Ablation in Treating Patients With Stage I Non-Small Cell Lung Cancer

26 januari 2017 uppdaterad av: Alliance for Clinical Trials in Oncology

A Pilot Study of Radiofrequency Ablation in High-Risk Patients With Stage IA Non-Small Cell Lung Cancer

This pilot clinical trial studies how well radiofrequency ablation works in treating patients with stage IA non-small cell lung cancer. Radiofrequency ablation uses high-frequency electric current to kill tumor cells. Computed tomography (CT)-guided radiofrequency ablation may be a better treatment for non-small cell lung cancer.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

PRIMARY OBJECTIVES:

I. To assess the overall 2-year survival rate after radiofrequency ablation (RFA).

SECONDARY OBJECTIVES:

I. To assess freedom from regional or distant recurrence. II. To assess freedom from local recurrence in the ablated lobe. III. To estimate the number of procedures deemed technical successes. IV. To evaluate procedure-specific morbidity and mortality. V. To explore the utility of immediate (within 96 hours) post-RFA positron emission tomography (PET) in predicting overall survival and local control.

VI. To explore the effect of RFA on both short-term (3 months post-RFA) and long-term (24 months post-RFA) pulmonary function.

OUTLINE:

A radiofrequency electrode is placed by CT guidance into the target tumor. Patients undergo RFA directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° Celsius (C). Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 1 year.

Studietyp

Interventionell

Inskrivning (Faktisk)

54

Fas

  • Inte tillämpbar

Kontakter och platser

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

Studieorter

  • Förenta staterna
    • Alabama
      • Birmingham, Alabama, Förenta staterna, 35294
        • UAB Comprehensive Cancer Center
    • California
      • Los Angeles, California, Förenta staterna, 90095-1781
        • Jonsson Comprehensive Cancer Center at UCLA
      • Sacramento, California, Förenta staterna, 95817
        • University of California Davis Cancer Center
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, Förenta staterna, 02118
        • Boston University Cancer Research Center
    • Michigan
      • Royal Oak, Michigan, Förenta staterna, 48073
        • William Beaumont Hospital - Royal Oak Campus
    • New York
      • Stony Brook, New York, Förenta staterna, 11794-9446
        • Stony Brook University Cancer Center
    • North Carolina
      • Chapel Hill, North Carolina, Förenta staterna, 27599-7295
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
    • Ohio
      • Cincinnati, Ohio, Förenta staterna, 45220
        • Good Samaritan Hospital Cancer Treatment Center
    • Oregon
      • Portland, Oregon, Förenta staterna, 97213-2967
        • Providence Cancer Center at Providence Portland Medical Center
    • Rhode Island
      • Providence, Rhode Island, Förenta staterna, 02903
        • Rhode Island Hospital Comprehensive Cancer Center
    • Tennessee
      • Chattanooga, Tennessee, Förenta staterna, 37404
        • H. Clay Evans Johnson Cancer Center at Memorial Hospital
    • Texas
      • Dallas, Texas, Förenta staterna, 75230
        • Medical City Dallas Hospital
    • Utah
      • Salt Lake City, Utah, Förenta staterna, 84112
        • Huntsman Cancer Institute at University of Utah
    • Washington
      • Spokane, Washington, Förenta staterna, 99204
        • Providence Cancer Center at Sacred Heart Medical Center
      • Spokane, Washington, Förenta staterna, 99207
        • Providence Cancer Center at Holy Family Hospital
    • Wisconsin
      • Milwaukee, Wisconsin, Förenta staterna, 53226
        • Medical College of Wisconsin Cancer Center

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:

  • PRE-REGISTRATION CRITERIA:
  • Patients must have a lung nodule suspicious for clinical stage I non-small cell lung cancer (NSCLC)
  • Patient must have a mass =< 3 cm maximum diameter by CT size estimate: clinical stage IA
  • Patient must have been evaluated by a thoracic surgeon and been deemed at high risk for a lung resection; NOTE: if the evaluating surgeon is not a member of American College of Surgeons Oncology Group (ACOSOG), then an ACOSOG thoracic surgeon must confirm with dated signature that the patient is high-risk and appropriate for RFA
  • Patient must have fludeoxyglucose F 18 (FDG)-PET and a CT scan of the chest with upper abdomen within 60 days prior to pre-registration; patient must have pulmonary function tests (PFTs) within 120 days prior to registration
  • Patient must have an Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status 0, 1, or 2

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

    • Major criteria

      • Forced expiratory volume in one second (FEV1) =< 50% predicted
      • Diffusing capacity of the lung 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 arterial partial pressure of oxygen (pO2) =< 55 mmHg or oxygen saturation (SpO2) =< 88%
      • Partial pressure of carbon dioxide (pCO2) > 45 mmHg
      • 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 within 2 weeks of registration
  • REGISTRATION ACTIVATION CRITERIA:
  • Patient must have histologically or cytologically proven NSCLC, 3 cm or smaller, as determined by the largest dimension on CT lung windows
  • Patient's tumor must be non-contiguous with vital structures: trachea, esophagus, aorta, aortic arch branches and heart and lesions must be accessible via percutaneous transthoracic route
  • Patient must have all suspicious mediastinal lymph nodes (> 1 cm short-axis dimension on CT scan or positive on PET scan) assessed by the following 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: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Treatment (RFA therapy)
A radiofrequency electrode is placed by CT guidance into the target tumor. Patients undergo RFA directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
Procedur: Computed Tomography-Guided Optical Sensor-Guided Radiofrequency Ablation
Undergo RFA
Andra namn:
  • CT-guided optical sensor-guided radiofrequency ablation, CT-guided optical sensor-guided RF ablation

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall Survival at 2 Years
Tidsram: 2 years from registration
Percentage of participants who were alive at 2 years. The 2 year survival was estimated using the Kaplan Meier method.
2 years from registration

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall Time to Local Failure
Tidsram: Up to 2 years
The overall time to local failure was defined as the time from registration to documentation of > local failure. The local failure was defined as the recurrence in the same lobe or hilum (N1 nodes) or progression at the ablated site after treatment affects have subsided.
Up to 2 years
Overall Time to Recurrence
Tidsram: Up to 2 years
The overall time to recurrence was defined as the time from registration to documentation of disease recurrence. If a patient dies without a documentation of disease recurrence, the patient will be considered to have had tumor recurrence at the time of their death unless there is sufficient evidence to conclude no recurrence occurred prior to death.
Up to 2 years
Number of Procedures Deemed Technical Successes
Tidsram: Up to 2 years
The number of procedures deemed technical successes is defined as the number of patients with a RFA procedures deemed a technical success. A technical success is defined as follows: The pertinent captured images from the treatment CT showing RFA electrode placement and the recorded RFA generator parameters (e.g. impedance, current, power, treatment time and maximum intra-tumoral temperature) were reviewed by the quality control panel to determine technical success.
Up to 2 years
Incidence of Adverse Events
Tidsram: Up to 2 years
The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 was used to evaluate adverse event.> Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death.
Up to 2 years
Change in Pulmonary Function From Baseline at Month 3
Tidsram: Baseline and Month 3
Pulmonary function test values include forced expiratory volume 1 (FEV1) and carbon monoxide diffusion (DLCO). The distribution of clinically meaningful changes (10% increase or 10% decrease) in pulmonary function from the baseline to 3 was summarized.
Baseline and Month 3
Change in Pulmonary Function From Baseline at Month 24
Tidsram: Baseline and Month 24
Pulmonary function test values include forced expiratory volume 1 (FEV1) and carbon monoxide diffusion (DLCO). The distribution of clinically meaningful changes (10% increase or 10% decrease) in pulmonary function from the baseline to 24 was summarized.
Baseline and Month 24

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)

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

1 september 2006

Primärt slutförande (Faktisk)

1 augusti 2012

Avslutad studie (Faktisk)

1 februari 2013

Studieregistreringsdatum

Först inskickad

3 maj 2005

Först inskickad som uppfyllde QC-kriterierna

3 maj 2005

Första postat (Uppskatta)

4 maj 2005

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 mars 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 januari 2017

Senast verifierad

1 januari 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • ACOSOG-Z4033
  • CDR0000426417 (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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