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

Primary Purpose

Lung Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FDG
Sponsored by
American College of Radiology Imaging Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jonsson Comprehensive Cancer Center at UCLA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group A - 3 FDG-PET/CT Scans

Group B - 2 FDG-PET/CT + 1 Optional

Group C - Test-Retest

Arm Description

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.

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.

Test-retest sequence for FDG-PET/CT; two scans with optional volumetric CT to be completed prior to 1st cycle of chemotherapy.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 16, 2007
Last Updated
October 9, 2018
Sponsor
American College of Radiology Imaging Network
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00424138
Brief Title
FDG-PET/CT Scans in Patients With Stage IIIB or Stage IV NSCLC Undergoing Chemotherapy
Acronym
ACRIN6678
Official Title
[18F]FDG-PET/CT as a Predictive Marker of Tumor Response and Patient Outcome: Prospective Validation in Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Recruitment obstacles; data to be combined with other resources for analysis
Study Start Date
March 30, 2007 (Actual)
Primary Completion Date
August 31, 2011 (Actual)
Study Completion Date
August 31, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American College of Radiology Imaging Network
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A - 3 FDG-PET/CT Scans
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B - 2 FDG-PET/CT + 1 Optional
Arm Type
Experimental
Arm Description
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.
Arm Title
Group C - Test-Retest
Arm Type
Experimental
Arm Description
Test-retest sequence for FDG-PET/CT; two scans with optional volumetric CT to be completed prior to 1st cycle of chemotherapy.
Intervention Type
Radiation
Intervention Name(s)
FDG
Other Intervention Name(s)
fludeoxyglucose F 18
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Correlation of metabolic response after the first course of chemotherapy with progression-free survival
Time Frame
1st Course of Chemotherapy
Title
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
Title
Test-retest reproducibility of standardized uptake values (SUV) as measured by FDG-PET/CT scans
Time Frame
Within 7 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Weber, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Denise R. Aberle, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Barry A. Siegel, MD
Organizational Affiliation
Washington University Siteman Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Anthony F. Shields, MD, PhD
Organizational Affiliation
Barbara Ann Karmanos Cancer Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Karen Rickard
Organizational Affiliation
City of Hope Comprehensive Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ramaswamy Govindan, MD
Organizational Affiliation
Washington University Siteman Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Steven M. Dubinett, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Joel Karp, PhD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
See ACRIN data sharing policy: https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx
Links:
URL
https://clinicaltrials.gov/ct2/show/NCT00424138
Description
National Cancer Institute's clinical trials database
URL
http://www.acrin.org/6678_protocol.aspx
Description
For additional information on ACRIN 6678, visit ACRIN.ORG.

Learn more about this trial

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

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