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

Phase 2

• Conditions: Lung Cancer

• Registration Number: NCT00083083
• Lead Sponsor: American College of Radiology Imaging Network

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2004-05-14
• Study First Submitted QC: 2004-05-14
• Study First Posted: 2004-05-17
• Study Start: 2005-03
• Primary Completion: 2006-06
• Status Verified: 2007-10
• Last Update Submitted: 2011-02-26
• Last Update Posted: 2011-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relationship of survival to post-treatment peak standardized uptake value (SUV) as determined by the imaging institution

Secondary Outcome Measures

Name	Time	Method
Relationship of survival to post-treatment max SUV as determined by the imaging institute
Relationship of local control to post-treatment peak and max SUV as determined by the imaging institution
Relationship of survival and of local control to pre-treatment peak and max SUV as determined by the imaging institution
Reliability between peak and max SUV measurements both pre- and post-treatment
Proportion of participants who are either upstaged or downstaged by positron emission tomography scan
Reliability between PET scan-defined response to therapy measurements
Correlation of Ki-67 expression with peak and max pre-treatment SUV
Association between Ki-67 expression and overall survival at 2 years

Trial Locations

Locations (49)

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham; 🇺🇸 Birmingham, Alabama, United States

Scottsdale Medical Imaging, Limited; 🇺🇸 Scottsdale, Arizona, United States

USC/Norris Comprehensive Cancer Center and Hospital; 🇺🇸 Los Angeles, California, United States

Radiological Associates of Sacramento Medical Group at Sutter Cancer Center; 🇺🇸 Sacramento, California, United States

Hospital of Saint Raphael; 🇺🇸 New Haven, Connecticut, United States

Bethesda Comprehensive Cancer Care Center at Bethesda Memorial Hospital; 🇺🇸 Boynton Beach, Florida, United States

North Broward Medical Center; 🇺🇸 Dearfield Beach, Florida, United States

Integrated Community Oncology Network at Baptist Cancer Institute; 🇺🇸 Jacksonville, Florida, United States

Tallahassee Memorial Hospital; 🇺🇸 Tallahassee, Florida, United States

Rush Cancer Institute at Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

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