Lung CancerACRIN6678NCT00424138
FDG-PET/CT Scans in Patients With Stage IIIB or Stage IV NSCLC Undergoing Chemotherapy
A study testing FDG in people with Lung Cancer, run by American College of Radiology Imaging Network at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- FDG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2007to 31 Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-1781
About this study
Official title: [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.
Read the 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
- Being tested
- FDG
- 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
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDGRadiation
Also called fludeoxyglucose F 18
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Radiation: FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of 1-year overall survival as measured by monitoring changes in tumor metabolic response during the first course of chemotherapy
Measured: 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
Measured: 1st Course Chemotherapy
Correlation of metabolic response after the first course of chemotherapy with progression-free survival
Measured: 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
Measured: One year
Test-retest reproducibility of standardized uptake values (SUV) as measured by FDG-PET/CT scans
Measured: Within 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2007 (estimated)
- Study start30 Mar 2007
- Primary completion31 Aug 2011
- Study completion31 Aug 2011
Why it stopped: Recruitment obstacles; data to be combined with other resources for analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- American College of Radiology Imaging Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Wolfgang Weber, MD, Study chair, Jonsson Comprehensive Cancer CenterDenise R. Aberle, MD, Study chair, Jonsson Comprehensive Cancer CenterBarry A. Siegel, MD, Study chair, Washington University Siteman Cancer CenterAnthony F. Shields, MD, PhD, Study chair, Barbara Ann Karmanos Cancer InstituteKaren Rickard, Study chair, City of Hope Medical CenterRamaswamy Govindan, MD, Study chair, Washington University Siteman Cancer CenterSteven M. Dubinett, MD, Study chair, Jonsson Comprehensive Cancer CenterJoel Karp, PhD, Study chair, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00424138
- Sponsor's protocol ID
- CDR0000527084
- Other IDs
- ACRIN-6678, U01CA080098, U01CA079778
- Acronym
- ACRIN6678
- Status last verified
- Oct 2018
- First submitted
- 16 Jan 2007
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: See ACRIN data sharing policy: https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [18F]FDG-PET/CT as a Predictive Marker of Tumor Response and Patient Outcome: Prospective Validation in Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00424138
- Acronym / sponsor ID
- ACRIN6678 / CDR0000527084
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment obstacles; data to be combined with other resources for analysis
- Enrolment
- 96 participants (actual)
- Lead sponsor
- American College of Radiology Imaging NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 Mar 2007 (actual)
- Primary completion
- 31 Aug 2011 (actual)
- Study completion
- 31 Aug 2011 (actual)
- First posted
- 18 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A - 3 FDG-PET/CT Scans | Experimental | Radiation: FDGTwo 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 B - 2 FDG-PET/CT + 1 Optional | Experimental | Radiation: FDGOne 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 C - Test-Retest | Experimental | Radiation: FDGTest-retest sequence for FDG-PET/CT; two scans with optional volumetric CT to be completed prior to 1st cycle of chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FDGAlso: fludeoxyglucose F 18 | Radiation | Group A - 3 FDG-PET/CT Scans, Group B - 2 FDG-PET/CT + 1 Optional, Group C - Test-Retest |
Primary outcome
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
4 secondary outcomes
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
Correlation of metabolic response after the first course of chemotherapy with progression-free survival
Time frame: 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
Time frame: One year
Test-retest reproducibility of standardized uptake values (SUV) as measured by FDG-PET/CT scans
Time frame: Within 7 Days
Results and safety
The study was stopped early (reason given: Recruitment obstacles; data to be combined with other resources for analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- National Cancer Institute's clinical trials databaseLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. See ACRIN data sharing policy: https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang Weber, MD study chair
Jonsson Comprehensive Cancer Center
Denise R. Aberle, MD study chair
Jonsson Comprehensive Cancer Center
Barry A. Siegel, MD study chair
Washington University Siteman Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FDG in people with Lung Cancer, run by American College of Radiology Imaging Network at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment obstacles; data to be combined with other resources for analysis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.