Overview

This trial is active, not recruiting.

Condition lung cancer
Treatments carboplatin, cisplatin, docetaxel, etoposide, paclitaxel, vinblastine sulfate, vinorelbine tartrate, gene expression analysis, positron emission tomography, fludeoxyglucose f 18, radiation therapy
Phase phase 2
Sponsor American College of Radiology Imaging Network
Collaborator National Cancer Institute (NCI)
Start date March 2005
End date June 2006
Trial size 250 participants
Trial identifier NCT00083083, ACRIN-6668, CDR0000362061, NCT00194389, RTOG-0235

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose diagnostic

Primary Outcomes

Measure
Relationship of survival to post-treatment peak standardized uptake value (SUV) as determined by the imaging institution
time frame:

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed non-small cell lung cancer (NSCLC) - Clinical stage IIB or III disease - No small cell carcinoma - No stage IV disease* - No diffuse bronchoalveolar subtype - No planned definitive surgical resection NOTE: *Patients with evidence of stage IV disease by positron emission tomography are eligible if the evidence cannot be confirmed by other means AND the physician still plans to proceed with definitive chemoradiation - Planning treatment with definitive chemoradiotherapy - May be treated on another Radiation Therapy Oncology Group protocol (except phase I studies) OR with conventional concurrent NSCLC chemoradiotherapy - Radiotherapy ≥ 60 Gy AND chemotherapy to include concurrent platinum-based therapy - No brain metastases by head CT scan or MRI PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Zubrod 0-1 Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Medically suitable for early concurrent chemoradiotherapy (radiotherapy dose ≥ 60 Gy) - Able to tolerate positron emission tomography imaging - No poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL) - No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy - No anticipated use of adjuvant biologic therapy beyond 14 weeks after the completion of radiotherapy Chemotherapy - See Disease Characteristics - No anticipated use of adjuvant chemotherapy beyond 14 weeks after the completion of radiotherapy Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - No prior thoracic radiotherapy - No concurrent intensity-modulated radiotherapy Surgery - See Disease Characteristics

Additional Information

Official title Positron Emission Tomography Pre- and Post-treatment Assessment For Locally Advanced Non-Small Cell Lung Carcinoma
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2011.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).