Non-small Cell Lung CancerNCT01619241
Pilot Study for Evaluating the Role of F-18 FLT PET/CT in Therapeutic Decision Making in Non-small Cell Lung Cancer
An observational study of Non-small Cell Lung Cancer, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
The objective of this pilot study is to determine whether 18F-FLT PET/CT can predict which patients will have poorer progression free survival and overall survival in advanced Non-small Cell Lung Cancer (NSCLC) after first-line therapy and, therefore, need more aggressive treatment. 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?
- PET/CT
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2012to Aug 2015
- Phase
- Observational
- 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
Study population: advanced non-small cell lung cancer
Who may be able to join
- advanced non-small cell lung cancer (stage IIIB, IV)
- at least one measurable lesion
- performance status (ECOG) 0-2
- 1st-line platinum chemotherapy and no progression
Who cannot join
- mixed small cell and non-small cell
- uncontrolled brain metastasis
- previous malignancy within 5 years (except basal cell carcinoma of skin, carcinoma in situ of uterine cervix)
- pregnant or breast feeding
- pemetrexed chemotherapy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul St.Mary's Hospital
Seoul, 137-701
Woo Hee Choi, MD, 82-31-249-8494, choiwoohee@gmail.com
Hyun Su Choi, MD, 82-2-2258-1550, hyun1318@hanmail.net
About this study
Official title: The Role of F-18 FLT PET/CT for Selecting the Patients Who Need Maintenance Treatment After First-line Chemotherapy in Advanced Non-small Cell Lung Cancers
The objective of this pilot study is to determine whether 18F-FLT PET/CT can predict which patients will have poorer progression free survival and overall survival in advanced Non-small Cell Lung Cancer (NSCLC) after first-line therapy and, therefore, need more aggressive treatment.
Read the detailed description
Standard therapy for patients with advanced NSCLC is platinum based doublet chemotherapy. Current first-line chemotherapy is usually limited to 4-6 cycles, as prolonging treatment does not result in additional benefit and may often cause further toxicity. Until recently, treatment guidelines recommended withholding administration of later-line systemic anti-cancer treatment until disease progression.
There are several reports suggesting that maintenance therapy following first-line chemotherapy offers improved survival in advance stage patients. This approach involves the administration of an active treatment immediately after first-line chemotherapy, thus maintaining the clinical benefit initially obtained. However, drug related toxicity and costs are of great concern. There may also be patients with less aggressive disease where an immediate transition to maintenance therapy after first-line results in overtreatment.
Therefore, selecting patients who require more aggressive treatment or earlier intervention is necessary.
If FLT PET/CT can discriminate the patients with shorter progression free survival and overall survival in this pilot study, patients could be selected for more aggressive or earlier treatment such as maintenance therapy, and the investigators could expect to prolong survival while reducing the adverse events and costs that will accompany inconsequential therapy with FLT PET/CT.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- PET/CT
- Keywords
- lung cancer, F-18 FLT PET/CT
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CTOther
Also called F-18 FLT PET/CT
F-18 FLT PET/CT
| Study group | Role | What they receive |
|---|---|---|
| advanced non-small cell lung cancer | Not described Receives: Other: PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: from the date of FLT PET/CT to the date of death or last follow-up, assessed up to 1 year
Secondary outcomes (1)
time to progression
Measured: from the date of FLT PET/CT to the date of documented progression or last follow-up, assessed up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2013 (estimated)
- Study completionAug 2015 (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.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ie Ryung Yoo, The Catholic University of Korea
- Investigators
- Ie Ryung Yoo, MD, Principal investigator, Seoul St. Mary's HospitalJin Hyoung Kang, MD, PhD, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619241
- Sponsor's protocol ID
- KC12EISI0104
- Other IDs
- KC12EISI0104
- Status last verified
- Jun 2012
- First submitted
- 24 May 2012
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of F-18 FLT PET/CT for Selecting the Patients Who Need Maintenance Treatment After First-line Chemotherapy in Advanced Non-small Cell Lung Cancers
- ClinicalTrials.gov ID
- NCT01619241
- Acronym / sponsor ID
- KC12EISI0104
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- lung cancer, F-18 FLT PET/CT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 14 Jun 2012 (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 objective of this pilot study is to determine whether 18F-FLT PET/CT can predict which patients will have poorer progression free survival and overall survival in advanced Non-small Cell Lung Cancer (NSCLC) after first-line therapy and, therefore, need more aggressive treatment.
Detailed description
Standard therapy for patients with advanced NSCLC is platinum based doublet chemotherapy. Current first-line chemotherapy is usually limited to 4-6 cycles, as prolonging treatment does not result in additional benefit and may often cause further toxicity. Until recently, treatment guidelines recommended withholding administration of later-line systemic anti-cancer treatment until disease progression.
There are several reports suggesting that maintenance therapy following first-line chemotherapy offers improved survival in advance stage patients. This approach involves the administration of an active treatment immediately after first-line chemotherapy, thus maintaining the clinical benefit initially obtained. However, drug related toxicity and costs are of great concern. There may also be patients with less aggressive disease where an immediate transition to maintenance therapy after first-line results in overtreatment.
Therefore, selecting patients who require more aggressive treatment or earlier intervention is necessary.
If FLT PET/CT can discriminate the patients with shorter progression free survival and overall survival in this pilot study, patients could be selected for more aggressive or earlier treatment such as maintenance therapy, and the investigators could expect to prolong survival while reducing the adverse events and costs that will accompany inconsequential therapy with FLT PET/CT.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| advanced non-small cell lung cancer | – | Other: PET/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- advanced non-small cell lung cancer
Key inclusion criteria (4 listed)
- advanced non-small cell lung cancer (stage IIIB, IV)
- at least one measurable lesion
- performance status (ECOG) 0-2
- 1st-line platinum chemotherapy and no progression
Key exclusion criteria (5 listed)
- mixed small cell and non-small cell
- uncontrolled brain metastasis
- previous malignancy within 5 years (except basal cell carcinoma of skin, carcinoma in situ of uterine cervix)
- pregnant or breast feeding
- pemetrexed chemotherapy
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 |
|---|---|---|
| PET/CTAlso: F-18 FLT PET/CTF-18 FLT PET/CT | Other | advanced non-small cell lung cancer |
Primary outcome
overall survival
Time frame: from the date of FLT PET/CT to the date of death or last follow-up, assessed up to 1 year
1 secondary outcome
time to progression
Time frame: from the date of FLT PET/CT to the date of documented progression or last follow-up, assessed up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 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.
Ie Ryung Yoo, MD principal investigator
Seoul St. Mary's Hospital
Jin Hyoung Kang, MD, PhD principal investigator
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by The Catholic University of Korea at 1 site in South Korea.
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 4 inclusion and 5 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 14 Jun 2012. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Woo Hee Choi, MD (82-31-249-8494, choiwoohee@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: from the date of FLT PET/CT to the date of death or last follow-up, assessed up to 1 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 14 Jun 2012.