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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

change in response rate

Outcome Description:

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%.

Outcome Time Frame:

within 4 cycles

Safety Issue:

No

Principal Investigator

Sang-We Kim, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center

Authority:

South Korea: Institutional Review Board

Study ID:

AMC 08-351

NCT ID:

NCT01170923

Start Date:

September 2008

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • non small cell lung cancer
  • FDG PET
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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