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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01619241
• Other study ID #: KC12EISI0104
• Secondary ID: KC12EISI0104
• Status: Not yet recruiting
• Phase: N/A
• First received: May 24, 2012
• Last updated: June 12, 2012
• Start date: June 2012
• Est. completion date: August 2015

Study information

• Verified date: June 2012
• Source: The Catholic University of Korea
• Contact: Woo Hee Choi, MD
• Phone: 82-31-249-8494
• Email: choiwoohee[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: August 2015
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Other:
• PET/CT
F-18 FLT PET/CT

Locations

Country	Name	City	State
Korea, Republic of	Seoul St.Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		from the date of FLT PET/CT to the date of death or last follow-up, assessed up to 1 year	No
Secondary	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	No