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

26. Januar 2017 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

54

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Verfahren: Computed Tomography-Guided Optical Sensor-Guided Radiofrequency Ablation
Undergo RFA
Andere Namen:
  • CT-guided optical sensor-guided radiofrequency ablation, CT-guided optical sensor-guided RF ablation

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Overall Survival at 2 Years
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Overall Time to Local Failure
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Alliance for Clinical Trials in Oncology

Mitarbeiter

National Cancer Institute (NCI)

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. September 2006

Primärer Abschluss (Tatsächlich)

1. August 2012

Studienabschluss (Tatsächlich)

1. Februar 2013

Studienanmeldedaten

Zuerst eingereicht

3. Mai 2005

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

3. Mai 2005

Zuerst gepostet (Schätzen)

4. Mai 2005

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

8. März 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

26. Januar 2017

Zuletzt verifiziert

1. Januar 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • ACOSOG-Z4033
  • CDR0000426417 (Registrierungskennung: NCI Physician Data Query)

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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