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

July 27, 2010 updated by: Asan Medical Center

Standard Chemotherapy Strategy Versus Changing Chemotherapy Strategy as to FDG-PET Response After 1st Cycle of Standard Chemotherapy for Advanced Non-small Cell Lung Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histologically confirmed non-small cell carcinoma.
  2. Stage IIIB (wet) or IV advanced NSCLC.
  3. 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.
  4. Measurable disease by RECIST criteria.

  5. 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
  6. 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:

  1. Previous chemotherapy.
  2. Symptomatic brain metastasis.
  3. Concurrent severe medical illness.
  4. Pregnancy and lactation.

  5. If there are findings which may increase risk with chemotherapy or inhibit to analyze the result of clinical trial.

    • Uncontrolled diabetes mellitus.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FDG-PET guided
Chemotherapy regimen will be changed depending on metabolic response.
Device: FDR-PET
FDR-PET performed after 1 cycle of chemotherapy
Active Comparator: CT guided
Chemotherapy regimen will be changed depending on CT findings (RECIST).
Device: CT
CT performed after 3 cycles of chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in response rate
Time Frame: within 4 cycles
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Collaborators

Boryung Pharmaceutical Co., Ltd

Investigators

  • Principal Investigator: Sang-We Kim, MD, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Anticipated)

August 1, 2010

Study Registration Dates

First Submitted

July 27, 2010

First Submitted That Met QC Criteria

July 27, 2010

First Posted (Estimate)

July 28, 2010

Study Record Updates

Last Update Posted (Estimate)

July 28, 2010

Last Update Submitted That Met QC Criteria

July 27, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMC 08-351

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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