Fludeoxyglucose F18 Positron Emission Tomography Imaging In Assessing Patients Before and After Treatment for Locally Advanced Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title: Positron Emission Tomography Pre- and Post-treatment Assessment For Locally Advanced Non-Small Cell Lung Carcinoma

Status Active, not recruiting

Clinical Trial Summary

RATIONALE: Imaging procedures, such as fludeoxyglucose F18 positron emission tomography (^18FDG-PET), may improve the ability to detect disease progression and help doctors predict a patient's response to treatment and plan more effective treatment.

PURPOSE: This phase II trial is studying how well ^18FDG-PET imaging works in detecting disease progression and determining response to treatment in patients who are undergoing chemoradiotherapy for locally advanced non-small cell lung cancer.

Clinical Trial Description

OBJECTIVES:

Primary

• Determine whether peak standardized uptake value (SUV) for fludeoxyglucose F 18 positron emission tomography (FDG-PET) shortly after definitive chemoradiotherapy is predictive of long-term survival of patients with inoperable stage IIB or III non-small cell lung cancer.

Secondary

• Determine whether max SUV for FDG-PET shortly after definitive chemoradiotherapy is predictive of long-term survival in these patients.

• Determine whether post-treatment imaging using peak and max SUV for FDG-PET shortly after definitive chemoradiotherapy is predictive of local disease control in these patients.

• Determine whether pre-treatment imaging using these techniques is predictive of long-term survival and local disease control in these patients.

• Correlate, if possible, Ki-67 expression with overall survival of patients assessed with these imaging techniques.

OUTLINE: This is a diagnostic, multicenter study.

Before starting chemoradiotherapy, patients undergo baseline whole-body positron emission tomography (PET) imaging. Patients receive fludeoxyglucose F 18 (^18FDG) IV followed 50-70 minutes later by PET imaging. Patients then receive concurrent definitive radiotherapy and chemotherapy. Patients enrolled in other treatment-oriented clinical trials receive therapy as per that trial. Other patients receive standard thoracic radiotherapy (dose ≥ 60 Gy) and standard chemotherapy comprising a platin (cisplatin or carboplatin) and a second non-platin, non-gemcitabine drug (etoposide, vinblastine, vinorelbine, paclitaxel, or docetaxel). Approximately 14 weeks after completion of chemoradiotherapy and adjuvant chemotherapy (if given), patients undergo post-treatment ^18FDG-PET imaging.

Patients are followed every 3 months for 2 years and then every 6 months for at least 1 year.

PROJECTED ACCRUAL: A total of 250 patients (including at least 75 with stage IIB/IIIA disease and at least 75 with stage IIIB disease) will be accrued for this study within 2 years. ;

Study Design

Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

• NCT number: NCT00083083
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 2005