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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


N/A
18 Years
N/A
Not Enrolling
Both
Non-small Cell Lung Cancer

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

overall survival

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Ie Ryung Yoo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul St. Mary's Hospital

Authority:

Korea: Institutional Review Board

Study ID:

KC12EISI0104

NCT ID:

NCT01619241

Start Date:

June 2012

Completion Date:

August 2015

Related Keywords:

  • Non-Small Cell Lung Cancer
  • lung cancer
  • F-18 FLT PET/CT
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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