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CompletedPhase 3NCT00107172
Official study title

Surgery With or Without Internal Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedsurgery and brachytherapy

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 18, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?38 U.S. locations

Locations may change over time.

Who runs it?Alliance for Clinical Trials in Oncology

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Alliance for Clinical Trials in Oncology
Interventions being studied
Procedure: surgery; Radiation: brachytherapy
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Early-stage or resectable→
Treatment approach
Radiation therapy→Surgery→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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)

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Mayo Clinic ScottsdaleScottsdale, Arizona
  • University of California Davis Cancer CenterSacramento, California
  • Mayo Clinic - JacksonvilleJacksonville, Florida
  • Winship Cancer Institute of Emory UniversityAtlanta, Georgia
  • Evanston HospitalEvanston, Illinois
  • Cancer Institute at St. John's HospitalSpringfield, Illinois
  • Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois
  • Simmons Cooper Cancer InstituteSpringfield, Illinois
  • Cancer Institute at St. Joseph Medical CenterTowson, Maryland
  • Boston University Cancer Research CenterBoston, Massachusetts
  • University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan
  • Mayo Clinic Cancer CenterRochester, Minnesota

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 18, 2019. Always confirm current availability with the study team.

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