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Phase II Study Evaluating Docetaxel and CDDP as Neoadjuvant Chemotherapy Prior to Surgery, Followed by Adjuvant Docetaxel Plus CDDP in Chemonaive Patients With NSCLC Stage III


Phase 2
20 Years
N/A
Not Enrolling
Both
NSCLC

Thank you

Trial Information

Phase II Study Evaluating Docetaxel and CDDP as Neoadjuvant Chemotherapy Prior to Surgery, Followed by Adjuvant Docetaxel Plus CDDP in Chemonaive Patients With NSCLC Stage III


Inclusion Criteria:



- Histologically or cytologically confirmed NSCLC, respectable NSCLC stage IIIa T1-2 N2
or or unresectable stage IIIb 2.KPS>70%
3.Hb>10g/dl,ANC>2.0x109/L,Plt.>100x109/L4.T-bil.<1xULN,creatinine<1xULN,creatinine
clearance >60 ml/min,GPT/GOT<2.5xULN,ALP<5xULN

Exclusion Criteria:

- 1.Brain meta.2..Prior surgery,R/T, C/t or immunotherapy for NSCLC

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall response rate

Outcome Time Frame:

every cycle during 2nd-6th cycles

Safety Issue:

No

Principal Investigator

Chong-Jen Yu, M.D,Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Internal Medicine, National Taiwan University hospital

Authority:

Taiwan: Department of Health

Study ID:

930911

NCT ID:

NCT00172380

Start Date:

February 2005

Completion Date:

March 2010

Related Keywords:

  • NSCLC
  • Carcinoma, Non-Small-Cell Lung

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