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
  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 Phase
Lung Cancer
Drug: chemotherapy
Radiation: fludeoxyglucose F 18
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: [18F]FDG-PET/CT as a Predictive Marker of Tumor Response and Patient Outcome: Prospective Validation in Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by American College of Radiology Imaging Network:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 96
Study Start Date: March 2007
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
Radiation: fludeoxyglucose F 18

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 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.

  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 (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00424138

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
American College of Radiology Imaging Network
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: American College of Radiology Imaging Network
ClinicalTrials.gov Identifier: NCT00424138     History of Changes
Other Study ID Numbers: CDR0000527084, ACRIN-6678, CA80098
Study First Received: January 16, 2007
Last Updated: February 4, 2013
Health Authority: United States: Federal Government

Keywords provided by American College of Radiology Imaging Network:
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

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Fluorodeoxyglucose F18
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014