Stage IIIA Non-small Cell Lung CancerNCT01314677
Fludeoxyglucose F 18 PET/CT Scans in Predicting Therapy Response in Patients With Stage IIIA Non-Small Cell Lung Cancer Undergoing Chemoradiation
A study testing positron emission tomography/computed tomography (PET/CT) and fludeoxyglucose F 18 in people with Stage IIIA Non-small Cell Lung Cancer, run by City of Hope Medical Center.
Trial summary
This clinical trial studies fludeoxyglucose F 18 (FDG) positron emission tomography (PET)/computed tomography (CT) in predicting chemoradiation therapy (CRT) failure in patients with stage IIIA non-small cell lung cancer (NSCLC). Diagnostic procedures, such as FDG PET/CT, may help predict CRT failure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stage IIIA Non-small Cell Lung Cancer
- What is being tested?
- positron emission tomography/computed tomography (PET/CT) and fludeoxyglucose F 18
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Jun 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients with marginally resectable IIIA (N2) NSCLC undergoing induction CRT will be eligible for this imaging trial; patients will be screened by the chest tumor board for entry
- Undergoing or plan to undergo induction chemoradiation
Who cannot join
- Poorly controlled or uncontrolled diabetes mellitus, with blood glucose > 200 mg/dl
- Have allergies or medical contra-indications to FDG or intravenous (IV) contrast
- Medical contra-indications to obtaining CT or PET scans
- Pre-authorization denial of coverage by insurance providers of clinical staging and restaging PET-CT scans
About this study
Official title: Open Label Randomized Trial of Early Assessment of Therapy Response Using 18FDG-PET/CT in Patients With Marginally Resectable Stage IIIA (N2) Non-Small Cell Lung Cancer (NSCLC) Treated With Induction Concurrent Chemoradiation Followed by Resection and Adjuvant Chemotherapy
This clinical trial studies fludeoxyglucose F 18 (FDG) positron emission tomography (PET)/computed tomography (CT) in predicting chemoradiation therapy (CRT) failure in patients with stage IIIA non-small cell lung cancer (NSCLC). Diagnostic procedures, such as FDG PET/CT, may help predict CRT failure. Comparing diagnostic results during CRT may help doctors predict a patient's response to treatment and help plan the best treatment
Read the detailed description
PRIMARY OBJECTIVES:
- To determine whether early response of the research positron emission tomography (PET)-computed tomography(CT) scan measured by change in Standard Uptake Value (SUV)max relative to baseline scan can predict induction chemoradiation therapy (CRT) failures sooner than post-treatment PET-CT scan.
II. To determine the optimal timing for 18FDG PET-CT that best predicts for induction CRT failure.
SECONDARY OBJECTIVES:
- To correlate early 18 fludeoxyglucose (FDG) PET-CT response metrics with pathologic response, progression-free survival separately for: induction CRT failures vs. non-failures, or overall survival separately for induction CRT failures vs. non-failures.
OUTLINE: Patients are randomized to 1 of 3 groups.
Patients undergo a baseline FDG PET/CT scan and receive standard radiotherapy (RT) for 28 fractions with concurrent chemotherapy.
GROUP A: Patients undergo a FDG PET/CT scan between RT fractions 5-6 (before course 2 of chemotherapy).
GROUP B: Patients undergo a FDG PET/CT scan between RT fractions 10-11 (before course 3 of chemotherapy).
GROUP C: Patients undergo a FDG PET/CT scan between RT fractions 15-16 (before course 4 of chemotherapy).
Approximately 6 weeks after completion of CRT, patients undergo a FDG PET/CT scan and undergo standard tumor resection.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months thereafter.
- Conditions
- Stage IIIA Non-small Cell Lung Cancer
- Being tested
- positron emission tomography/computed tomography (PET/CT), fludeoxyglucose F 18
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positron emission tomography/computed tomography (PET/CT)Procedure or surgery
Undergo FDG PET/CT
fludeoxyglucose F 18Radiation
Also called 18FDG, FDG
Undergo FDG PET/CT
| Study group | Role | What they receive |
|---|---|---|
| Group A (FDG PET/CT between RT fractions 5-6) | Experimental | Patients undergo a baseline FDG PET/CT scan and receive standard radiotherapy (RT) for 28 fractions with concurrent chemotherapy.
Patients undergo a FDG PET/CT scan between RT fractions 5-6 (before course 2 of chemotherapy).
Approximately 6 weeks after completion of CRT, patients undergo a FDG PET/CT scan and undergo standard tumor resection. Receives: Procedure: positron emission tomography/computed tomography (PET/CT); Radiation: fludeoxyglucose F 18 |
| Group B (FDG PET/CT between RT fractions 10-11) | Experimental | Patients undergo a baseline FDG PET/CT scan and receive standard radiotherapy (RT) for 28 fractions with concurrent chemotherapy.
Patients undergo a FDG PET/CT scan between RT fractions 10-11 (before course 3 of chemotherapy).
Approximately 6 weeks after completion of CRT, patients undergo a FDG PET/CT scan and undergo standard tumor resection. Receives: Procedure: positron emission tomography/computed tomography (PET/CT); Radiation: fludeoxyglucose F 18 |
| Group C (FDG PET/CT between RT fractions 15-16) | Experimental | Patients undergo a baseline FDG PET/CT scan and receive standard radiotherapy (RT) for 28 fractions with concurrent chemotherapy.
Patients undergo a FDG PET/CT scan between RT fractions 15-16 (before course 4 of chemotherapy).
Approximately 6 weeks after completion of CRT, patients undergo a FDG PET/CT scan and undergo standard tumor resection. Receives: Procedure: positron emission tomography/computed tomography (PET/CT); Radiation: fludeoxyglucose F 18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induction therapy failure
Defined as any evidence by clinically unresectable disease based on tumor board consensus and review of restaging scans demonstrating locoregional progression or distant metastasis, surgically unresectable disease based on surgical exploration, or suboptimal resection disease still requiring pneumonectomy and still having R1 resection.
Measured: 6 weeks after completion of chemoradiation therapy (CRT)
Early positron emission tomography (PET) response of group A
Measured by the change in Standard Uptake Value (SUV)max from baseline at the research PET scan in 1 of 3 scheduled time point.
Measured: Baseline and between standard radiotherapy (RT) fractions 5-6
Early positron emission tomography (PET) response of group B
Measured by the change in Standard Uptake Value (SUV)max from baseline at the research PET scan in 1 of 3 scheduled time point.
Measured: Baseline and between standard radiotherapy (RT) fractions 10-11
Early positron emission tomography (PET) response of group C
Measured by the change in Standard Uptake Value (SUV)max from baseline at the research PET scan in 1 of 3 scheduled time point.
Measured: Baseline and between standard radiotherapy (RT) fractions 15-16
Secondary outcomes (3)
Pathologic response
Measured: 6 weeks after completion of chemoradiation therapy (CRT)
Progression-free survival
Measured: Every 3 months for 2 years and every 6 months thereafter
Overall survival
Measured: Every 3 months for 2 years and every 6 months thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: No subjects have been accrued to this trial. The PI will no longer be at COH and requests a study withdrawal/closure.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IIIA Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Khanh Nguyen, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314677
- Sponsor's protocol ID
- 10012
- Other IDs
- NCI-2011-00337
- Status last verified
- Jun 2012
- First submitted
- 11 Mar 2011
- Last updated
- 29 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Randomized Trial of Early Assessment of Therapy Response Using 18FDG-PET/CT in Patients With Marginally Resectable Stage IIIA (N2) Non-Small Cell Lung Cancer (NSCLC) Treated With Induction Concurrent Chemoradiation Followed by Resection and Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT01314677
- Acronym / sponsor ID
- 10012
- Conditions
- Stage IIIA Non-small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No subjects have been accrued to this trial. The PI will no longer be at COH and requests a study withdrawal/closure.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 14 Mar 2011 (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.
This clinical trial studies fludeoxyglucose F 18 (FDG) positron emission tomography (PET)/computed tomography (CT) in predicting chemoradiation therapy (CRT) failure in patients with stage IIIA non-small cell lung cancer (NSCLC). Diagnostic procedures, such as FDG PET/CT, may help predict CRT failure. Comparing diagnostic results during CRT may help doctors predict a patient's response to treatment and help plan the best treatment
Detailed description
PRIMARY OBJECTIVES:
- To determine whether early response of the research positron emission tomography (PET)-computed tomography(CT) scan measured by change in Standard Uptake Value (SUV)max relative to baseline scan can predict induction chemoradiation therapy (CRT) failures sooner than post-treatment PET-CT scan.
II. To determine the optimal timing for 18FDG PET-CT that best predicts for induction CRT failure.
SECONDARY OBJECTIVES:
- To correlate early 18 fludeoxyglucose (FDG) PET-CT response metrics with pathologic response, progression-free survival separately for: induction CRT failures vs. non-failures, or overall survival separately for induction CRT failures vs. non-failures.
OUTLINE: Patients are randomized to 1 of 3 groups.
Patients undergo a baseline FDG PET/CT scan and receive standard radiotherapy (RT) for 28 fractions with concurrent chemotherapy.
GROUP A: Patients undergo a FDG PET/CT scan between RT fractions 5-6 (before course 2 of chemotherapy).
GROUP B: Patients undergo a FDG PET/CT scan between RT fractions 10-11 (before course 3 of chemotherapy).
GROUP C: Patients undergo a FDG PET/CT scan between RT fractions 15-16 (before course 4 of chemotherapy).
Approximately 6 weeks after completion of CRT, patients undergo a FDG PET/CT scan and undergo standard tumor resection.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months thereafter.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (FDG PET/CT between RT fractions 5-6) | Experimental | Procedure: positron emission tomography/computed tomography (PET/CT), Radiation: fludeoxyglucose F 18Patients undergo a baseline FDG PET/CT scan and receive standard radiotherapy (RT) for 28 fractions with concurrent chemotherapy. Patients undergo a FDG PET/CT scan between RT fractions 5-6 (before course 2 of chemotherapy). Approximately 6 weeks after completion of CRT, patients undergo a FDG PET/CT scan and undergo standard tumor resection. |
| Group B (FDG PET/CT between RT fractions 10-11) | Experimental | Procedure: positron emission tomography/computed tomography (PET/CT), Radiation: fludeoxyglucose F 18Patients undergo a baseline FDG PET/CT scan and receive standard radiotherapy (RT) for 28 fractions with concurrent chemotherapy. Patients undergo a FDG PET/CT scan between RT fractions 10-11 (before course 3 of chemotherapy). Approximately 6 weeks after completion of CRT, patients undergo a FDG PET/CT scan and undergo standard tumor resection. |
| Group C (FDG PET/CT between RT fractions 15-16) | Experimental | Procedure: positron emission tomography/computed tomography (PET/CT), Radiation: fludeoxyglucose F 18Patients undergo a baseline FDG PET/CT scan and receive standard radiotherapy (RT) for 28 fractions with concurrent chemotherapy. Patients undergo a FDG PET/CT scan between RT fractions 15-16 (before course 4 of chemotherapy). Approximately 6 weeks after completion of CRT, patients undergo a FDG PET/CT scan and undergo standard tumor resection. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All patients with marginally resectable IIIA (N2) NSCLC undergoing induction CRT will be eligible for this imaging trial; patients will be screened by the chest tumor board for entry
- Undergoing or plan to undergo induction chemoradiation
Key exclusion criteria (4 listed)
- Poorly controlled or uncontrolled diabetes mellitus, with blood glucose > 200 mg/dl
- Have allergies or medical contra-indications to FDG or intravenous (IV) contrast
- Medical contra-indications to obtaining CT or PET scans
- Pre-authorization denial of coverage by insurance providers of clinical staging and restaging PET-CT scans
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 |
|---|---|---|
| positron emission tomography/computed tomography (PET/CT)Undergo FDG PET/CT | Procedure or surgery | Group A (FDG PET/CT between RT fractions 5-6), Group B (FDG PET/CT between RT fractions 10-11), Group C (FDG PET/CT between RT fractions 15-16) |
| fludeoxyglucose F 18Also: 18FDG, FDGUndergo FDG PET/CT | Radiation | Group A (FDG PET/CT between RT fractions 5-6), Group B (FDG PET/CT between RT fractions 10-11), Group C (FDG PET/CT between RT fractions 15-16) |
Primary outcome
Induction therapy failure
Time frame: 6 weeks after completion of chemoradiation therapy (CRT)
Defined as any evidence by clinically unresectable disease based on tumor board consensus and review of restaging scans demonstrating locoregional progression or distant metastasis, surgically unresectable disease based on surgical exploration, or suboptimal resection disease still requiring pneumonectomy and still having R1 resection.
Early positron emission tomography (PET) response of group A
Time frame: Baseline and between standard radiotherapy (RT) fractions 5-6
Measured by the change in Standard Uptake Value (SUV)max from baseline at the research PET scan in 1 of 3 scheduled time point.
Early positron emission tomography (PET) response of group B
Time frame: Baseline and between standard radiotherapy (RT) fractions 10-11
Measured by the change in Standard Uptake Value (SUV)max from baseline at the research PET scan in 1 of 3 scheduled time point.
Early positron emission tomography (PET) response of group C
Time frame: Baseline and between standard radiotherapy (RT) fractions 15-16
Measured by the change in Standard Uptake Value (SUV)max from baseline at the research PET scan in 1 of 3 scheduled time point.
3 secondary outcomes
Pathologic response
Time frame: 6 weeks after completion of chemoradiation therapy (CRT)
Progression-free survival
Time frame: Every 3 months for 2 years and every 6 months thereafter
Overall survival
Time frame: Every 3 months for 2 years and every 6 months thereafter
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2012.
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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.
Khanh Nguyen principal investigator
City of Hope Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing positron emission tomography/computed tomography (PET/CT) and fludeoxyglucose F 18 in people with Stage IIIA Non-small Cell Lung Cancer, run by City of Hope Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 29 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Induction therapy failure (time frame: 6 weeks after completion of chemoradiation therapy (CRT)). The study lists 4 primary outcomes in all. 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 29 Jun 2012.