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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2012 by The Catholic University of Korea
Sponsor:
Information provided by (Responsible Party):
Ie Ryung Yoo, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01619241
First received: May 24, 2012
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Non-small Cell Lung Cancer
Other: PET/CT

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time to progression [ Time Frame: from the date of FLT PET/CT to the date of documented progression or last follow-up, assessed up to 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: June 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
advanced non-small cell lung cancer Other: PET/CT
F-18 FLT PET/CT
Other Name: F-18 FLT PET/CT

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

advanced non-small cell lung cancer

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01619241

Contacts
Contact: Woo Hee Choi, MD 82-31-249-8494 choiwoohee@gmail.com

Locations
Korea, Republic of
Seoul St.Mary's Hospital Not yet recruiting
Seoul, Korea, Republic of, 137-701
Contact: Woo Hee Choi, MD    82-31-249-8494    choiwoohee@gmail.com   
Contact: Hyun Su Choi, MD    82-2-2258-1550    hyun1318@hanmail.net   
Principal Investigator: Ie Ryung Yoo, MD         
Principal Investigator: Jin Hyoung Kang, MD, PhD         
Sub-Investigator: Hyun Su Choi, MD         
Sub-Investigator: Woo Hee Choi, MD         
Sub-Investigator: Narae Lee, MD         
Sponsors and Collaborators
The Catholic University of Korea
Investigators
Principal Investigator: Ie Ryung Yoo, MD Seoul St. Mary's Hospital
Principal Investigator: Jin Hyoung Kang, MD, PhD Seoul St. Mary's Hospital
  More Information

No publications provided

Responsible Party: Ie Ryung Yoo, Chief of Nuclear Medicine department, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01619241     History of Changes
Other Study ID Numbers: KC12EISI0104, KC12EISI0104
Study First Received: May 24, 2012
Last Updated: June 12, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by The Catholic University of Korea:
lung cancer
F-18 FLT PET/CT

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 21, 2014