Phase II Study of Docetaxel Plus CDDP for NSCLC Stage III

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00172380

Enrollment

Registered

2005-09-15

Start date

2005-02-28

Completion date

2010-03-31

Last updated

2012-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NSCLC

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.

Interventions

DRUGDocetaxel Plus CDDP

docetaxel 36mg/m2 and cisplatin 75mg/m2

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
overall response rate	every cycle during 2nd-6th cycles

Secondary

Measure	Time frame
resectability	resectability after treatment
progression free survival	progression free survival after 1 year
overall survival	overall survival at 1 year

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026