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Pilot Study for Evaluating the Role of F-18 FLT PET/CT in Therapeutic Decision Making in Non-small Cell Lung Cancer

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01619241
Enrollment
15
Registered
2012-06-14
Start date
2012-06-30
Completion date
2015-08-31
Last updated
2012-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

lung cancer, F-18 FLT PET/CT

Brief 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.

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.

Interventions

OTHERPET/CT

F-18 FLT PET/CT

Sponsors

The Catholic University of Korea
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
overall survivalfrom the date of FLT PET/CT to the date of death or last follow-up, assessed up to 1 year

Secondary

MeasureTime frame
time to progressionfrom the date of FLT PET/CT to the date of documented progression or last follow-up, assessed up to 1 year

Countries

South Korea

Contacts

Primary ContactWoo Hee Choi, MD
choiwoohee@gmail.com82-31-249-8494

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026