Lung Cancer Clinical Trial
— ACRIN6678Official title:
[18F]FDG-PET/CT as a Predictive Marker of Tumor Response and Patient Outcome: Prospective Validation in Non-Small Cell Lung Cancer
Verified date | October 2018 |
Source | American College of Radiology Imaging Network |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 treatment.
PURPOSE: This clinical trial is studying ^18FDG PET/CT scans to see how well they predict
response in patients undergoing chemotherapy for stage IIIB or stage IV non-small cell lung
cancer.
Status | Terminated |
Enrollment | 96 |
Est. completion date | August 31, 2011 |
Est. primary completion date | August 31, 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Jonsson Comprehensive Cancer Center at UCLA | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
American College of Radiology Imaging Network | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prediction of 1-year overall survival as measured by monitoring changes in tumor metabolic response during the first course of chemotherapy | One year | ||
Secondary | Correlation of metabolic response after the first course of chemotherapy with subsequent best tumor response as measured by RECIST criteria | 1st Course Chemotherapy | ||
Secondary | Correlation of metabolic response after the first course of chemotherapy with progression-free survival | 1st Course of Chemotherapy | ||
Secondary | Predictive value of fludeoxyglucose F 18 positron emission tomography (FDG-PET) for 1-year overall survival after the first and second course of chemotherapy | One year | ||
Secondary | Test-retest reproducibility of standardized uptake values (SUV) as measured by FDG-PET/CT scans | Within 7 Days |
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