Phase II Study of Docetaxel Plus CDDP for NSCLC Stage III

Phase 2

Completed

• Conditions: NSCLC
• Interventions: Drug: Docetaxel Plus CDDP

• Registration Number: NCT00172380
• Lead Sponsor: National Taiwan University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Primary Completion: 2010-01
• Study Completion: 2010-03
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-19
• Last Update Posted: 2012-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
docetaxel and cisplatin	Docetaxel Plus CDDP	docetaxel 36mg/m2 and cisplatin 75mg/m2

Primary Outcome Measures

Name	Time	Method
overall response rate	every cycle during 2nd-6th cycles

Secondary Outcome Measures

Name	Time	Method
resectability	resectability after treatment
progression free survival	progression free survival after 1 year
overall survival	overall survival at 1 year

Trial Locations

Locations (1)

Department of Internal Medicine, National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan