FDG-PET/CT Scans in Patients With Stage IIIB or Stage IV NSCLC Undergoing Chemotherapy (ACRIN6678)
Lung Cancer

About this trial
This is an interventional diagnostic trial for Lung Cancer focused on measuring stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer, stage IIIA non-small cell lung cancer
Eligibility Criteria
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
Sites / Locations
- Jonsson Comprehensive Cancer Center at UCLA
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Group A - 3 FDG-PET/CT Scans
Group B - 2 FDG-PET/CT + 1 Optional
Group C - Test-Retest
Two FDG-PET/CT scans prior to 1st cycle of chemotherapy, plus 2 optional volumetric CT scans. One FDG-PET/CT after 1st cycle of chemotherapy, plus 1 optional volumetric CT scan.
One FDG-PET/CT prior to 1st cycle of chemotherapy; 1 FDG-PET/CT after the 1st cycle of chemotherapy; 1 optional FDG-PET/CT after the 2nd cycle of chemotherapy. All three with optional volumetric CT scans.
Test-retest sequence for FDG-PET/CT; two scans with optional volumetric CT to be completed prior to 1st cycle of chemotherapy.