Status:
TERMINATED
FDG-PET/CT Scans in Patients With Stage IIIB or Stage IV NSCLC Undergoing Chemotherapy
Lead Sponsor:
American College of Radiology Imaging Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
RATIONALE: Diagnostic procedures, such as fludeoxyglucose F 18 (\^18FDG) positron emission tomography (PET)/CT scans, may help doctors predict a patient's response to treatment and help plan the best ...
Detailed Description
OBJECTIVES: * Determine whether a metabolic response, defined as a 25% decrease in peak tumor standardized uptake value (SUV) after the first course of chemotherapy, provides early prediction of trea...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer
- Newly diagnosed stage IIIB (with malignant pleural effusion) or stage IV disease (Group I and II), or newly diagnosed stage IIIA, IIIB, or IV (Group III) determined by all of the following:
- CT scan or MRI of the chest and upper abdomen (including liver and adrenal glands) within the past 4 weeks
- History/physical examination within the past 6 weeks
- CT scan or MRI of the brain within the past 4 weeks, if there is headache, mental/physical impairment, or other signs or symptoms suggesting brain metastases within the past 2 months
- No small cell carcinoma
- No pure bronchioloalveolar carcinoma
- Patients with recurrent or metastatic disease are eligible provided they meet 1 of the following criteria:
- Received surgery or radiotherapy for treatment of the primary tumor and locoregional disease ≥ 3 months prior to study entry AND have a measurable lesion in the chest
- Received chemotherapy in the adjuvant setting or as part of combined modality therapy for locoregional disease ≥ 3 months prior to recurrent or metastatic disease diagnosis AND have a measurable lesion in the chest
- Measurable disease, defined as at least 1 measurable primary tumor or other intrathoracic/supraclavicular lesion ≥ 2 cm
- Scheduled to be treated with a platinum-based dual-agent chemotherapy regimen administered at 3-week intervals with or without bevacizumab or cetuximab (Group I and II)
- Scheduled to be treated with standard chemotherapy in the current protocol, other standard chemotherapy, experimental chemotherapy, or other treatment including no treatment (Group III)
- No symptomatic brain metastases (Groups I and II only)
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2 (Groups I and II only)
- Group III may include potential participants regardless of ECOG performance status score
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to tolerate positron emission tomography (PET)/CT scanning
- No contraindication to chemotherapy and PET/CT scanning, as demonstrated by laboratory testing
- No poorly controlled diabetes (i.e., fasting glucose level \> 150 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medications
- No prior malignancy other than basal cell or squamous cell carcinoma of the skin, carcinoma in situ, or other cancer from which the patient has been disease free for ≥ 3 years (Groups I and II)
- Prior malignancy is not an exclusion factor for Group III
- No clinical or radiographic signs of post-obstructive pneumonia
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 3 months since prior thoracic radiotherapy, lung surgery, or chemotherapy
- Prior chemotherapy in the adjuvant setting or as part of a combined modality regimen for locoregional disease that was given ≥ 3 months prior to diagnosis of recurrent or metastatic disease allowed
- No planned treatment with any targeted biologic therapy including gefitinib or erlotinib hydrochloride (Group I and II)
- No concurrent chemoradiotherapy
- No concurrent bevacizumab
Exclusion
Key Trial Info
Start Date :
March 30 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2011
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00424138
Start Date
March 30 2007
End Date
August 31 2011
Last Update
October 11 2018
Active Locations (1)
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1
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781