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

NCT ID: NCT01619241

Last Updated: 2012-06-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2015-08-31

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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

advanced non-small cell lung cancer

PET/CT

Intervention Type: OTHER

F-18 FLT PET/CT

Interventions

PET/CT

F-18 FLT PET/CT

Intervention Type: OTHER

Other Intervention Names

F-18 FLT PET/CT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Catholic University of Korea

OTHER

Sponsor Role: lead

Responsible Party

Ie Ryung Yoo

Chief of Nuclear Medicine department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ie Ryung Yoo, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital

Jin Hyoung Kang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital

Locations

Seoul St.Mary's Hospital

Seoul, , South Korea

Countries

South Korea

Central Contacts

Woo Hee Choi, MD

Role: CONTACT

choiwoohee@gmail.com

82-31-249-8494

Facility Contacts

Woo Hee Choi, MD

Role: primary

choiwoohee@gmail.com

82-31-249-8494

Hyun Su Choi, MD

Role: backup

hyun1318@hanmail.net

82-2-2258-1550

Other Identifiers

KC12EISI0104

Identifier Type: OTHER

Identifier Source: secondary_id

KC12EISI0104

Identifier Type: -

Identifier Source: org_study_id