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Fludeoxyglucose F 18 PET/CT Scans in Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer Undergoing Chemotherapy
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), May 2007
Sponsors and Collaborators: American College of Radiology Imaging Network
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00424138
  Purpose

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.


Condition Intervention
Lung Cancer
Drug: fludeoxyglucose F 18
Procedure: chemotherapy
Procedure: computed tomography
Procedure: positron emission tomography

MedlinePlus related topics: CT Scans Cancer Lung Cancer Nuclear Scans
Drug Information available for: Fluorodeoxyglucose F18
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic
Official Title: FDG-PET/CT as a Predictive Marker of Tumor Response and Patient Outcome: Prospective Validation in Non-Small Cell Lung Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Prediction of 1-year overall survival as measured by monitoring changes in tumor metabolic response during the first course of chemotherapy [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation of metabolic response after the first course of chemotherapy with subsequent best tumor response as measured by RECIST criteria [ Designated as safety issue: No ]
  • Correlation of metabolic response after the first course of chemotherapy with progression-free survival [ 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 [ Designated as safety issue: No ]
  • Test-retest reproducibility of standardized uptake values (SUV) as measured by FDG-PET/CT scans [ Designated as safety issue: No ]

Estimated Enrollment: 285
Study Start Date: March 2007
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
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 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 before starting treatment with platinum-based chemotherapy. Patients undergo additional ^18FDG PET/CT scanning once between the first and second course of chemotherapy.
  • Group II: Patients undergo ^18FDG PET/CT scanning once before starting treatment with platinum-based chemotherapy. Patients undergo additional ^18FDG PET/CT scanning once between the first and second and once between the second and third course of chemotherapy.
  • Group III: Patients undergo ^18FDG PET/CT scanning twice 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer

    • Newly diagnosed stage IIIB (with malignant pleural effusion) or stage IV disease, 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
  • 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
  • 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
  • No concurrent chemoradiotherapy
  • No concurrent bevacizumab
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00424138

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA Recruiting
Los Angeles, California, United States, 90095-1781
Contact: Clinical Trials Office - Jonsson Comprehensive Cancer Center a     888-798-0719        
Sponsors and Collaborators
American College of Radiology Imaging Network
Investigators
Study Chair: Wolfgang Weber, MD Jonsson Comprehensive Cancer Center
Investigator: Denise R. Aberle, MD Jonsson Comprehensive Cancer Center
Investigator: Barry A. Siegel, MD Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Investigator: Anthony F. Shields, MD, PhD Barbara Ann Karmanos Cancer Institute
Investigator: Karen Rickard, MD Jonsson Comprehensive Cancer Center
Investigator: Steven M. Dubinett, MD Jonsson Comprehensive Cancer Center
Investigator: Joel Karp, PhD University of Pennsylvania
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000527084, ACRIN-6678
Study First Received: January 16, 2007
Last Updated: November 26, 2008
ClinicalTrials.gov Identifier: NCT00424138  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009