Non-small Cell Lung CancerPhase 2NCT01170923
FDG-PET Scan Response Guided Chemotherapy Strategy for Advanced Non-small Cell Lung Cancer
A Phase 2 study testing FDR-PET and CT in people with Non-small Cell Lung Cancer, run by Asan Medical Center.
Trial summary
The usual response to chemotherapy is decided through the image change by computed tomography (CT), which is taken at least 6-9 weeks. In order to predict the response to chemotherapy earlier, patients received FDG-PET scan at the first cycle of chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- FDR-PET and CT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Aug 2010
- Phase
- Phase 2
- 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
Who may be able to join
- Histologically confirmed non-small cell carcinoma.
- Stage IIIB (wet) or IV advanced NSCLC.
- No evidence of prior malignancies for 3 years except treated basal cell or squamous cell carcinoma of skin and carcinoma in situ of uterine cervix.
- Measurable disease by RECIST criteria.
- Adequate organ function as follows.
- Seum AST/ALT < 2.5 x Upper normal limit (UNL) (if hepatic metastasis < 5 x UNL)
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- Total bilirubin < 1.5 x UNL
- Serum creatinine < 1.5 mg/dL
- Absolute neutrophil count > 1500/uL
- Platelet > 100,000/uL
- Hemoglobin > 9.0 g/dL
- ECOG Performance status 0-1 7 Age > 18
- 8. If previously treated with major surgery, it should be over at least 4 weeks. And if previously treated with radiotherapy, it should be over at least 2 weeks.
- 9. Written consent
Who cannot join
- Previous chemotherapy.
- Symptomatic brain metastasis.
- Concurrent severe medical illness.
- Pregnancy and lactation.
- If there are findings which may increase risk with chemotherapy or inhibit to analyze the result of clinical trial.
- Uncontrolled diabetes mellitus.
About this study
Official title: Standard Chemotherapy Strategy Versus Changing Chemotherapy Strategy as to FDG-PET Response After 1st Cycle of Standard Chemotherapy for Advanced Non-small Cell Lung Cancer
The usual response to chemotherapy is decided through the image change by computed tomography (CT), which is taken at least 6-9 weeks.
In order to predict the response to chemotherapy earlier, patients received FDG-PET scan at the first cycle of chemotherapy. Chemotherapy was guided by the metabolic response by FDG-PET scan.
Read the detailed description
Prospective, Open-label, Randomized phase II, single institution trial that compared chemotherapy guided by traditional evaluation based on RECIST versus chemotherapy guided by FDG-PET (metabolic) response.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- FDR-PET, CT
- Keywords
- non small cell lung cancer, FDG PET
- 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.
FDR-PETDevice
FDR-PET performed after 1 cycle of chemotherapy
CTDevice
CT performed after 3 cycles of chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| FDG-PET guided | Experimental | Chemotherapy regimen will be changed depending on metabolic response. Receives: Device: FDR-PET |
| CT guided | Active comparator | Chemotherapy regimen will be changed depending on CT findings (RECIST). Receives: Device: CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in response rate
The usual response rate of GenexolPM/Cisplatin chemotherapy is 30-40%. This trial will assess whether the changing chemotherapy strategy using FDG-PET can increase response rate by 15%.
Measured: within 4 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study startSep 2008
- Primary completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Asan 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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Boryung Pharmaceutical Co., Ltd
- Investigators
- Sang-We Kim, MD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170923
- Sponsor's protocol ID
- AMC 08-351
- Status last verified
- Jul 2010
- First submitted
- 27 Jul 2010
- Last updated
- 28 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Chemotherapy Strategy Versus Changing Chemotherapy Strategy as to FDG-PET Response After 1st Cycle of Standard Chemotherapy for Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01170923
- Acronym / sponsor ID
- AMC 08-351
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- non small cell lung cancer, FDG PET
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Boryung Pharmaceutical Co., Ltd
- Study start
- Sep 2008
- Primary completion
- Aug 2010 (estimated)
- First posted
- 28 Jul 2010 (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.
The usual response to chemotherapy is decided through the image change by computed tomography (CT), which is taken at least 6-9 weeks.
In order to predict the response to chemotherapy earlier, patients received FDG-PET scan at the first cycle of chemotherapy. Chemotherapy was guided by the metabolic response by FDG-PET scan.
Detailed description
Prospective, Open-label, Randomized phase II, single institution trial that compared chemotherapy guided by traditional evaluation based on RECIST versus chemotherapy guided by FDG-PET (metabolic) response.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FDG-PET guided | Experimental | Device: FDR-PETChemotherapy regimen will be changed depending on metabolic response. |
| CT guided | Active comparator | Device: CTChemotherapy regimen will be changed depending on CT findings (RECIST). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically confirmed non-small cell carcinoma.
- Stage IIIB (wet) or IV advanced NSCLC.
- No evidence of prior malignancies for 3 years except treated basal cell or squamous cell carcinoma of skin and carcinoma in situ of uterine cervix.
- Measurable disease by RECIST criteria.
- Adequate organ function as follows.
Key exclusion criteria (6 listed)
- Previous chemotherapy.
- Symptomatic brain metastasis.
- Concurrent severe medical illness.
- Pregnancy and lactation.
- If there are findings which may increase risk with chemotherapy or inhibit to analyze the result of clinical trial.
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 |
|---|---|---|
| FDR-PETFDR-PET performed after 1 cycle of chemotherapy | Device | FDG-PET guided |
| CTCT performed after 3 cycles of chemotherapy | Device | CT guided |
Primary outcome
change in response rate
Time frame: within 4 cycles
The usual response rate of GenexolPM/Cisplatin chemotherapy is 30-40%. This trial will assess whether the changing chemotherapy strategy using FDG-PET can increase response rate by 15%.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2010.
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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.
Sang-We Kim, MD principal investigator
Asan Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FDR-PET and CT in people with Non-small Cell Lung Cancer, run by Asan 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 14 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 28 Jul 2010. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
change in response rate (time frame: within 4 cycles). 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 28 Jul 2010.