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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Prospective Study of the Prognostic Significance of Occult Metastases in the Patient With Resectable Non-Small Cell Lung Carcinoma

NCT00003901•Alliance for Clinical Trials in Oncology

View on ClinicalTrials.gov

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.

Detailed Description

OBJECTIVES: * Determine the relationship between three indicators of occult metastases (cytological examination of pleural lavage, immunohistochemistry (IHC) assay of lymph nodes, and IHC assay of rib bone marrow) and survival of patients with resectable non-small cell lung cancer. * Determine the relationship between these indicators and conventional histology. * Model survival considering the indicators and other patient attributes that are of prime prognostic significance. * Determine the relationships between the indicators and the site of first recurrence in these patients. * Determine the prevalence of the indicators in these patients. * Determine the relationships between the indicators and disease free survival in these patients.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion 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.
+4 more criteria

Exclusion 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.

Locations (58)

Providence Cancer Center

Mobile, Alabama, United States

Mobile Infirmary Medical Center

Mobile, Alabama, United States

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

Huntington Cancer Center at Huntington Hospital

Pasadena, California, United States

University of California Davis Cancer Center

Sacramento, California, United States

UCSF Comprehensive Cancer Center

San Francisco, California, United States

University of Colorado Health Sciences Center - Denver

Denver, Colorado, United States

Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

Fort Lauderdale, Florida, United States

Bayfront Medical Center

St. Petersburg, Florida, United States

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Key Dates

Start Date

July 1, 1999

Primary Completion Date

October 1, 2011

Completion Date

October 1, 2011

Last Updated

February 16, 2017

Enrollment

1,310

ACTUAL participants

Conditions

Lung Cancer

Interventions

immunohistochemistry staining method

OTHER

biopsy

PROCEDURE

surgery

PROCEDURE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 16, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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