FDG-PET Scan Response Guided Chemotherapy Strategy for Ad... | NCT01170923

Studies
FDG-PET Scan Response Guided Chemotherapy Strategy for Advanced Non-small Cell Lung Cancer

NCT01170923

Sponsor

Asan Medical Center

Status

Unknown status

Last Update Posted

Jul 28, 2010Estimated

Enrollment

100Estimated

Phase

Phase 2

Conditions

Non-small Cell Lung Cancer

Interventions

FDR-PET
CT

Countries

Not provided

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

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Aug 2010Estimated

Completion Date

Not provided

First Submitted Date

Jul 27, 2010

First Submission Date that Met QC Criteria

Jul 27, 2010

First Posted Date

Jul 28, 2010Estimated

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

Jul 27, 2010

Last Update Posted Date

Jul 28, 2010Estimated

Name	Class
Boryung Pharmaceutical Co., Ltd	INDUSTRY

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 usual response to chemotherapy is decided through the image change by computed tomography (CT), which is taken at least 6-9 weeks.

In order to predict the response to chemotherapy earlier, patients received FDG-PET scan at the first cycle of chemotherapy. Chemotherapy was guided by the metabolic response by FDG-PET scan.

Detailed Description

Prospective, Open-label, Randomized phase II, single institution trial that compared chemotherapy guided by traditional evaluation based on RECIST versus chemotherapy guided by FDG-PET (metabolic) response.

Design Module

Study Type

Interventional

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FDG-PET guided	Experimental	Chemotherapy regimen will be changed depending on metabolic response.	Device: FDR-PET
CT guided	Active Comparator	Chemotherapy regimen will be changed depending on CT findings (RECIST).	Device: CT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FDR-PET	Device	FDR-PET performed after 1 cycle of chemotherapy	FDG-PET guided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in response rate	The usual response rate of GenexolPM/Cisplatin chemotherapy is 30-40%. This trial will assess whether the changing chemotherapy strategy using FDG-PET can increase response rate by 15%.	within 4 cycles

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed non-small cell carcinoma.
Stage IIIB (wet) or IV advanced NSCLC.
No evidence of prior malignancies for 3 years except treated basal cell or squamous cell carcinoma of skin and carcinoma in situ of uterine cervix.
Measurable disease by RECIST criteria.
Adequate organ function as follows.
- Seum AST/ALT < 2.5 x Upper normal limit (UNL) (if hepatic metastasis < 5 x UNL)
- Total bilirubin < 1.5 x UNL
- Serum creatinine < 1.5 mg/dL
- Absolute neutrophil count > 1500/uL
- Platelet > 100,000/uL
- Hemoglobin > 9.0 g/dL
ECOG Performance status 0-1 7 Age > 18

8. If previously treated with major surgery, it should be over at least 4 weeks. And if previously treated with radiotherapy, it should be over at least 2 weeks.

9. Written consent

Exclusion Criteria:

Previous chemotherapy.
Symptomatic brain metastasis.
Concurrent severe medical illness.
Pregnancy and lactation.
If there are findings which may increase risk with chemotherapy or inhibit to analyze the result of clinical trial.
- Uncontrolled diabetes mellitus.

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

Not provided

Sampling Method

Not provided

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms