Thoracoscopy in Patients With Stage IIIA Non-Small Cell Lung Cancer

Alliance for Clinical Trials in Oncology

Status: Completed

Conditions: Lung Cancer

Treatments: Procedure: videothoracoscopy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00003566

CALGB-39803

CLB-39803

CDR0000066632 (Registry Identifier)

U10CA031946 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

RATIONALE: Diagnostic procedures such as thoracoscopy may help to measure a patient's response to previous treatment.

PURPOSE: Diagnostic trial to determine the accuracy of thoracoscopy in patients who have stage IIIA non-small cell lung cancer.

Full description

OUTLINE: The purpose of this study is to test the usefulness and safety of restaging the patient's cancer by a procedure called a thoracoscopy. Restaging is a process by which physicians measure the response of the patient to treatment. The primary and secondary objectives are described below.

OBJECTIVES:

Primary Objective:

1. Evaluate the feasibility of using videothoracoscopy to access and identify residual viable cancer in mediastinal lymph nodes and/or evaluate for other conditions which render patients unresectable (pleural carcinomatosis or T4 primary tumors) following prior mediastinoscopy and a period of neoadjuvant therapy for Stage IIIA N2 non-small cell lung cancer.

Secondary Objectives:

1. Evaluate the safety (morbidity and mortality) of pre-resectional, thoracoscopic restaging of patients who have undergone prior mediastinoscopy and induction therapy for Stage III (N2) NSCLC.
2. Assess the accuracy (false-negative rate) of thoracoscopic mediastinal node restaging after prior mediastinoscopy and induction therapy.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Histologic Documentation: All patients must have histologic documentation of Stage IIIA non-small cell lung cancer on the basis of involved N2 nodes from a documented mediastinoscopy performed prior to induction therapy. Previously treated relapsed patients are not eligible.
2. Prior Treatment: greater than or equal to 2 cycles of chemotherapy with or without radiotherapy (greater than or equal to 40 Gy) or radiotherapy alone (greater than or equal to 40 Gy) must be completed within 60 days of registration.
3. No distant metastatic disease or local disease progression. Patients with responding or stable local disease are eligible. Those with local disease progression defined as a 25% increase in local tumor size or the appearance of new areas of malignant disease are ineligible.
4. No previous intrapleural surgery on the ipsilateral side.
5. ECOG Performance Status: 0-2

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

video-thorascopy + surgery

Experimental group

Description:

Patients will undergo ipsilateral video-thorascopic evaluation. Patients may undergo surgery at the discretion of the surgeon and treating physicians.

Treatment:

Procedure: videothoracoscopy