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CompletedPhase 2NCT00002624
Official study title

Video-Assisted Surgery Followed by Radiation Therapy in Treating Patients With Stage I Non-small Cell Lung Cancer and Poor Heart and Lung Function

Study summary

RATIONALE: Video-assisted surgery followed by radiation therapy may be an effective treatment in patients whose poor heart and lung function make them high risk for standard surgery. PURPOSE: Phase II trial to study the effectiveness of video-assisted surgery followed by radiation therapy in treating patients with stage I non-small cell lung cancer and poor heart and lung function.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedadjuvant therapy and diagnostic thoracoscopy

Plus 3 other study approaches.

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 Jul 14, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?16 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 2
Sponsor
Alliance for Clinical Trials in Oncology
Interventions being studied
Procedure: adjuvant therapy; Procedure: diagnostic thoracoscopy; Procedure: therapeutic thoracoscopy; Procedure: video-assisted surgery; Radiation: radiation therapy
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
  • DISEASE CHARACTERISTICS:
  • Known or suspected, single, peripheral, stage T1 N0 M0 lung tumor
  • Tumor must not be identifiable by bronchoscopy
  • Bronchoscopically visible cancer or bronchial distortions considered related to tumor
  • Positive cytology by bronchoscopy allowed if no gross abnormality visible
  • Mediastinoscopy required for nodes greater than 1 cm
  • No pleural effusions
  • No metastatic or N2 disease on CT scan
  • Lesion must be accessible for video-assisted thoracoscopic wedge resection
  • High cardiopulmonary risk for thoracotomy with at least 1 of the following criteria:
  • FEV1 less than 40% predicted
  • DLCO less than 50% predicted
  • Supplemental oxygen requirement
  • Chronic PaCO2 greater than 45 mm Hg
  • Maximum oxygen consumption (VO2 max) less than 15 mL/kg/min
  • Patients who appear at high risk for non-pulmonary reasons (e.g., patients who are elderly or with renal or cardiac failure) may be eligible only if VO2 max or other criteria above are met
  • Eligible for radiotherapy after completion of wedge resection if histologic documentation of non-small cell lung cancer, including any of the following subtypes:
  • Squamous cell carcinoma
  • Adenocarcinoma
  • Bronchoalveolar cell
  • Large cell anaplastic carcinoma
  • Cytology from bronchial washings and transthoracic needle aspiration not acceptable PATIENT CHARACTERISTICS: Age:
  • 18 and over Performance status:
  • 0-2 Other:
  • No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix
  • Weight loss no greater than 10% within the past 6 months PRIOR CONCURRENT THERAPY: Radiotherapy
  • No prior thoracic irradiation

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

  • CCOP - Colorado Cancer Research Program, IncorporatedDenver, Colorado
  • John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa
  • Mercy Cancer Center at Mercy Medical Center-Des MoinesDes Moines, Iowa
  • Iowa Lutheran HospitalDes Moines, Iowa
  • Beth Israel Deaconess Medical CenterBoston, Massachusetts
  • CCOP - Metro-MinnesotaSaint Louis Park, Minnesota
  • Midlands Cancer Center at Midlands Community HospitalPapillion, Nebraska
  • MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico
  • Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania
  • Drexel University HospitalPhiladelphia, Pennsylvania
  • Hillman Cancer Center at University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania
  • CCOP - MainLine HealthWynnewood, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 14, 2016. Always confirm current availability with the study team.

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