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

NCT00424138 | Terminated DMC

• 4 other identifiers: CDR0000527084ACRIN-6678U01CA080098U01CA079778
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  One year

Secondary Outcomes (4)

• 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

Study Arms (3)

Group A - 3 FDG-PET/CT Scans

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Group C - Test-Retest

EXPERIMENTAL

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

Radiation: FDG

Interventions

FDG RADIATION

Also known as: fludeoxyglucose F 18

Group A - 3 FDG-PET/CT Scans; Group B - 2 FDG-PET/CT + 1 Optional; Group C - Test-Retest

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• American College of Radiology Imaging Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

Related Links

• National Cancer Institute's clinical trials database

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• 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 at Penn Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2007
• First Posted: January 18, 2007
• Study Start: March 30, 2007
• Primary Completion: August 31, 2011
• Study Completion: August 31, 2011
• Last Updated: October 11, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)