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

26 januari 2017 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

54

Fase

  • Niet toepasbaar

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

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

  • 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)

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: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Procedure: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall Survival at 2 Years
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall Time to Local Failure
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

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)

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

1 september 2006

Primaire voltooiing (Werkelijk)

1 augustus 2012

Studie voltooiing (Werkelijk)

1 februari 2013

Studieregistratiedata

Eerst ingediend

3 mei 2005

Eerst ingediend dat voldeed aan de QC-criteria

3 mei 2005

Eerst geplaatst (Schatting)

4 mei 2005

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 maart 2017

Laatste update ingediend die voldeed aan QC-criteria

26 januari 2017

Laatst geverifieerd

1 januari 2017

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

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