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NCT00172380 Clinical Trial

Phase II Study of Docetaxel Plus CDDP for NSCLC Stage III

NSCLC Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00172380
Other study ID # 930911
Secondary ID
Status Completed
Phase Phase 2
First received September 12, 2005
Last updated December 19, 2012
Start date February 2005
Est. completion date March 2010

Study information
Verified date December 2012
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial Summary

To assess the overall response rate to docetaxel plus CDDP as neoadjuvant chemotherapy prior to surgery, followed by adjuvant docetaxel plus CDDP in chemonaive patients NSCLC Stage IIIa and IIIb.

Recruitment information / eligibility
Status Completed
Enrollment 41
Est. completion date March 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Docetaxel Plus CDDP
docetaxel 36mg/m2 and cisplatin 75mg/m2

Locations
Country Name City State
Taiwan Department of Internal Medicine, National Taiwan University Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary overall response rate every cycle during 2nd-6th cycles No
Secondary resectability resectability after treatment No
Secondary progression free survival progression free survival after 1 year No
Secondary overall survival overall survival at 1 year No
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