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Clinical Trials/NCT01619241
NCT01619241
Unknown
Not Applicable

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

The Catholic University of Korea1 site in 1 country15 target enrollmentJune 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Non-small Cell Lung Cancer
Sponsor
The Catholic University of Korea
Enrollment
15
Locations
1
Primary Endpoint
overall survival
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2012
End Date
August 2015
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ie Ryung Yoo

Chief of Nuclear Medicine department

The Catholic University of Korea

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

Outcomes

Primary Outcomes

overall survival

Time Frame: from the date of FLT PET/CT to the date of death or last follow-up, assessed up to 1 year

Secondary Outcomes

  • 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)

Study Sites (1)

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