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

[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.

Study Overview

• Status: Terminated
• Conditions: Lung Cancer
• Intervention / Treatment: Radiation: FDG

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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095-1781
      • Jonsson Comprehensive Cancer Center at UCLA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Radiation: FDG; Other Names: fludeoxyglucose F 18
Experimental: Group B - 2 FDG-PET/CT + 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.	Radiation: FDG; Other Names: fludeoxyglucose F 18
Experimental: Group C - 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: FDG; Other Names: fludeoxyglucose F 18

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Prediction of 1-year overall survival as measured by monitoring changes in tumor metabolic response during the first course of chemotherapy	One year

Secondary Outcome Measures

Outcome Measure	Time Frame
Correlation of metabolic response after the first course of chemotherapy with subsequent best tumor response as measured by RECIST criteria	1st Course Chemotherapy
Correlation of metabolic response after the first course of chemotherapy with progression-free survival	1st Course of Chemotherapy
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
Test-retest reproducibility of standardized uptake values (SUV) as measured by FDG-PET/CT scans	Within 7 Days

Collaborators and Investigators

• Sponsor: American College of Radiology Imaging Network
• Collaborators: National Cancer Institute (NCI)
• 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, City of Hope Comprehensive Cancer Center; 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

Publications and helpful links

Helpful Links

• National Cancer Institute's clinical trials database
• For additional information on ACRIN 6678, visit ACRIN.ORG.

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2007
• Primary Completion (Actual): August 31, 2011
• Study Completion (Actual): August 31, 2011

Study Registration Dates

• First Submitted: January 16, 2007
• First Submitted That Met QC Criteria: January 16, 2007
• First Posted (Estimate): January 18, 2007

Study Record Updates

• Last Update Posted (Actual): October 11, 2018
• Last Update Submitted That Met QC Criteria: October 9, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: recurrent non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Fluorodeoxyglucose F18
• Other Study ID Numbers: CDR0000527084; U01CA080098 (U.S. NIH Grant/Contract); U01CA079778 (U.S. NIH Grant/Contract); ACRIN-6678 (Other Identifier: ACRIN Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

See ACRIN data sharing policy:

https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx