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

• Conditions: Non-small Cell Lung Cancer
• Interventions: Other: PET/CT

• Registration Number: NCT01619241
• Lead Sponsor: The Catholic University of Korea

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.

Study Timeline

• Study First Submitted: 2012-05-24
• Status Verified: 2012-06
• Study Start: 2012-06
• Study First Submitted QC: 2012-06-12
• Last Update Submitted: 2012-06-12
• Study First Posted: 2012-06-14
• Last Update Posted: 2012-06-14
• Primary Completion: 2013-08
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
advanced non-small cell lung cancer	PET/CT	-

Primary Outcome Measures

Name	Time	Method
overall survival	from the date of FLT PET/CT to the date of death or last follow-up, assessed up to 1 year

Secondary Outcome Measures

Name	Time	Method
time to progression	from the date of FLT PET/CT to the date of documented progression or last follow-up, assessed up to 1 year

Trial Locations

Locations (1)

Seoul St.Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of