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FDG-PET/CT Scans in Patients With Stage IIIB or Stage IV NSCLC Undergoing Chemotherapy (ACRIN 6678)

This study has been terminated.
(Recruitment obstacles; data to be combined with other resources for analysis)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
American College of Radiology Imaging Network
ClinicalTrials.gov Identifier:
NCT00424138
First received: January 16, 2007
Last updated: February 4, 2013
Last verified: February 2013

January 16, 2007
February 4, 2013
March 2007
August 2011   (final data collection date for primary outcome measure)
Prediction of 1-year overall survival as measured by monitoring changes in tumor metabolic response during the first course of chemotherapy [ Time Frame: One year ] [ Designated as safety issue: No ]
Prediction of 1-year overall survival as measured by monitoring changes in tumor metabolic response during the first course of chemotherapy
Complete list of historical versions of study NCT00424138 on ClinicalTrials.gov Archive Site
  • Correlation of metabolic response after the first course of chemotherapy with subsequent best tumor response as measured by RECIST criteria [ Time Frame: 1st Course Chemotherapy ] [ Designated as safety issue: No ]
  • Correlation of metabolic response after the first course of chemotherapy with progression-free survival [ Time Frame: 1st Course of Chemotherapy ] [ Designated as safety issue: No ]
  • Predictive value of fludeoxyglucose F 18 positron emission tomography (FDG-PET) for 1-year overall survival after the first and second course of chemotherapy [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Test-retest reproducibility of standardized uptake values (SUV) as measured by FDG-PET/CT scans [ Time Frame: Within 7 Days ] [ Designated as safety issue: No ]
  • Correlation of metabolic response after the first course of chemotherapy with subsequent best tumor response as measured by RECIST criteria
  • Correlation of metabolic response after the first course of chemotherapy with progression-free survival
  • Predictive value of fludeoxyglucose F 18 positron emission tomography (FDG-PET) for 1-year overall survival after the first and second course of chemotherapy
  • Test-retest reproducibility of standardized uptake values (SUV) as measured by FDG-PET/CT scans
Not Provided
Not Provided
 
FDG-PET/CT Scans in Patients With Stage IIIB or Stage IV NSCLC Undergoing Chemotherapy
[18F]FDG-PET/CT as a Predictive Marker of Tumor Response and Patient Outcome: Prospective Validation in Non-Small Cell Lung Cancer

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.

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 treatment outcome (tumor response and patient survival) in patients with stage IIIB or IV non-small cell lung cancer undergoing platinum-based chemotherapy.
  • Determine the test-retest reproducibility of quantitative assessment of tumor fludeoxyglucose F 18 (^18FDG) uptake in these patients.
  • Determine the time course of treatment-induced changes in tumor ^18FDG uptake in these patients.
  • Determine, in an exploratory analysis, changes in tumor volume during chemotherapy by multislice CT scanning in these patients.

OUTLINE: This is a prospective, multicenter study. Patients are assigned to 1 of 3 groups.

  • Group I: Patients undergo fludeoxyglucose F 18 (^18FDG) positron emission tomography (PET)/CT scanning twice and 1-2 volumetric CT scanning (1-7 days apart) before starting treatment with platinum-based chemotherapy. Patients undergo additional ^18FDG PET/CT scan and a volumetric CT scan once between the first and second course of chemotherapy.
  • Group II: Patients undergo ^18FDG PET/CT scan and volumetric CT scanning once before starting treatment with platinum-based chemotherapy. Patients undergo additional ^18FDG PET/CT scan and volumetric CT scanning once between the first and second course of chemotherapy, and may undergo once between the second and third course of chemotherapy.
  • Group III: Patients undergo ^18FDG PET/CT scanning twice (up to 1 week apart) before starting any treatment.

In groups I and II, patients also undergo standard follow-up CT scanning every 6 weeks (i.e., every other chemotherapy course) for up to 18 weeks.

After completion of chemotherapy, patients are followed every 3 months for up to 1 year.

Biomarker

  • Imaging: See
  • provided by American College of Radiology Network.

PROJECTED ACCRUAL: A total of 285 patients will be accrued for this study.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Lung Cancer
  • Drug: chemotherapy
  • Radiation: fludeoxyglucose F 18
  • Experimental: Group A - 3 FDG-PET/CT Scans
    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.
    Interventions:
    • Drug: chemotherapy
    • Radiation: fludeoxyglucose F 18
  • Experimental: Group B - 2 FDG-PET/CT Scans + 1 Optional
    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.
    Interventions:
    • Drug: chemotherapy
    • Radiation: fludeoxyglucose F 18
  • Experimental: Group C - 2 FDG-PET/CT Test-Retest
    Test-retest sequence for FDG-PET/CT; two scans with optional volumetric CT to be completed prior to 1st cycle of chemotherapy.
    Intervention: Radiation: fludeoxyglucose F 18
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
96
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00424138
CDR0000527084, ACRIN-6678, CA80098
Yes
American College of Radiology Imaging Network
American College of Radiology Imaging Network
National Cancer Institute (NCI)
Study Chair: Wolfgang Weber, MD Jonsson Comprehensive Cancer Center
Study Chair: Denise R. Aberle, MD Jonsson Comprehensive Cancer Center
Study Chair: Barry A. Siegel, MD Washington University Siteman Cancer Center
Study Chair: Anthony F. Shields, MD, PhD Barbara Ann Karmanos Cancer Institute
Study Chair: Karen Rickard Beckman Research Institute
Study Chair: Ramaswamy Govindan, MD Washington University Siteman Cancer Center
Study Chair: Steven M. Dubinett, MD Jonsson Comprehensive Cancer Center
Study Chair: Joel Karp, PhD Abramson Cancer Center of the University of Pennsylvania
American College of Radiology Imaging Network
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP