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

NCT ID: NCT00424138

Last Updated: 2018-10-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-30
• Study Completion Date: 2011-08-31

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

FDG

Intervention Type: RADIATION

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.

Group Type: EXPERIMENTAL

FDG

Intervention Type: RADIATION

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.

Group Type: EXPERIMENTAL

FDG

Intervention Type: RADIATION

Interventions

FDG

Intervention Type: RADIATION

Other Intervention Names

fludeoxyglucose F 18

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

American College of Radiology Imaging Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wolfgang Weber, MD

Role: STUDY_CHAIR

Jonsson Comprehensive Cancer Center

Denise R. Aberle, MD

Role: STUDY_CHAIR

Jonsson Comprehensive Cancer Center

Barry A. Siegel, MD

Role: STUDY_CHAIR

Washington University Siteman Cancer Center

Anthony F. Shields, MD, PhD

Role: STUDY_CHAIR

Barbara Ann Karmanos Cancer Institute

Karen Rickard

Role: STUDY_CHAIR

City of Hope Comprehensive Cancer Center

Ramaswamy Govindan, MD

Role: STUDY_CHAIR

Washington University Siteman Cancer Center

Steven M. Dubinett, MD

Role: STUDY_CHAIR

Jonsson Comprehensive Cancer Center

Joel Karp, PhD

Role: STUDY_CHAIR

Abramson Cancer Center at Penn Medicine

Locations

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, United States

Countries

United States

Related Links

https://clinicaltrials.gov/ct2/show/NCT00424138

National Cancer Institute's clinical trials database

Other Identifiers

ACRIN-6678

Identifier Type: OTHER

Identifier Source: secondary_id

U01CA080098

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U01CA079778

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000527084

Identifier Type: -

Identifier Source: org_study_id