CompletedPhase 3NCT00003901
Official study title

Prognostic Study of Metastases in Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer That Can Be Removed by Surgery

Study summary

RATIONALE: Prognostic testing for early signs of metastases may help doctors detect metastases early and plan more effective treatment. PURPOSE: Phase III trial to study the relationship between early signs of metastases and survival in patients who have stage I, stage II, or stage III non-small cell lung cancer that can be removed by surgery.

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Key things to know

Main goalDiagnostic

This describes the study’s primary purpose.

What is being studiedimmunohistochemistry staining method and biopsy

Plus 1 other study approaches.

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

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 16, 2017 · 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?58 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
Diagnostic
Study type
Interventional
Phase
Phase 3
Sponsor
Alliance for Clinical Trials in Oncology
Interventions being studied
Other: immunohistochemistry staining method; Procedure: biopsy; Procedure: surgery
02
Explore related studies

How this study is categorized

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

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

1. Patient must be ≥ 18 years old. 2. Patient must have ECOG/Zubrod status \< 3. 3. Patient must have clinically resectable, NSCLC (squamous cell, adenocarcinoma, or large cell) and be clinical Stage I, IIa, IIb or IIIa, according to the 1998 staging system of the American Joint Commission on Cancer for lung cancer. 4. Patient must have N1 or N2 disease. NOTE: Patient must undergo mediastinoscopy if preoperative studies suggest N3 disease. 5. Patient must have a pathologic diagnosis (pre-operative or intra-operative) of NSCLC prior to registration. 6. Patient must be anticipated to have a thoracotomy with the intention of a curative resection for primary NSCLC. NOTE: The preoperative assessment of resectability should, at a minimum, include a CT scan of the chest and upper abdomen, including the adrenal glands, within 60 days prior to registration. 7. Patient must be medically fit for surgery. 8. Patient must be a candidate for complete resection of the carcinoma via pneumonectomy, bilobectomy, lobectomy, or anatomic segmentectomy with or without sleeve resection. 9. Patient or the patient's legally acceptable representative must provide a signed and dated written informed consent prior to registration and any study-related procedures. 10. Patient must be available for follow-up. 11. If the patient is a survivor of a prior cancer, all of the following criteria must apply: 1. Patient has undergone potentially curative therapy for all prior malignancies, 2. No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for effectively treated basal cell or squamous carcinoma of the skin, carcinoma in-situ of the cervix that has been effectively treated by surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral breast treated by surgery alone), 3. Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.

Reasons someone may not be able to joinExclusion criteria

1. Patient has evidence of pleural effusion by physical assessment, lateral chest x-ray, or by chest CT scan. 2. Patient has had ipsilateral thoracotomy or thoracoscopy within the past 5 years. 3. Patient has received prior chemotherapy or radiotherapy for this cancer. 4. Patient is considered a poor surgical risk due to non-malignant systemic disease (cardiovascular, renal, etc.) that would preclude the treatment options. 5. Patient for whom the surgeon plans to perform only a wedge resection for treatment.

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

  • Providence Cancer CenterMobile, Alabama
  • Mobile Infirmary Medical CenterMobile, Alabama
  • USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California
  • Huntington Cancer Center at Huntington HospitalPasadena, California
  • University of California Davis Cancer CenterSacramento, California
  • UCSF Comprehensive Cancer CenterSan Francisco, California
  • University of Colorado Health Sciences Center - DenverDenver, Colorado
  • Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross HospitalFort Lauderdale, Florida
  • Bayfront Medical CenterSt. Petersburg, Florida
  • University of Chicago Cancer Research CenterChicago, Illinois
  • Alexian Brothers Medical CenterElk Grove Village, Illinois
  • Cancer Institute at St. John's HospitalSpringfield, Illinois

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 16, 2017. Always confirm current availability with the study team.

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