Pilot Study for Evaluating the Role of F-18 FLT PET/CT in... | NCT01619241

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

NCT01619241

Sponsor

The Catholic University of Korea

Status

Unknown status

Last Update Posted

Jun 14, 2012Estimated

Enrollment

15Estimated

Phase

Not provided

Conditions

Non-small Cell Lung Cancer

Interventions

PET/CT

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
KC12EISI0104	Other Identifier	Seoul St.Mary's Hospital Institutional Review Board

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Aug 2013Estimated

Completion Date

Aug 2015Estimated

First Submitted Date

May 24, 2012

First Submission Date that Met QC Criteria

Jun 12, 2012

First Posted Date

Jun 14, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2012

Last Update Posted Date

Jun 14, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ie Ryung Yoo, Chief of Nuclear Medicine department, The Catholic University of KoreaPrincipal Investigator

Lead Sponsor

The Catholic University of KoreaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
advanced non-small cell lung cancer			Other: PET/CT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PET/CT	Other	F-18 FLT PET/CT	advanced non-small cell lung cancer	F-18 FLT PET/CT

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

advanced non-small cell lung cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Woo Hee Choi, MD	Contact	82-31-249-8494		choiwoohee@gmail.com

Overall Officials

Name	Affiliation	Role
Ie Ryung Yoo, MD	Seoul St. Mary's Hospital	Principal Investigator
Jin Hyoung Kang, MD, PhD	Seoul St. Mary's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul St.Mary's Hospital		Seoul		137-701	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms

Browse Leaves

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Browse Branches

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