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

The Catholic University of Korea

Status: Unknown

Conditions: Non-small Cell Lung Cancer

Treatments: Other: PET/CT

Study type: Observational

Funder types: Other

Identifiers

NCT01619241

KC12EISI0104 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

15 participants in 1 patient group

advanced non-small cell lung cancer

Treatment:

Other: PET/CT