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Clinical Trials/NCT00172380
NCT00172380CompletedPhase 2

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

National Taiwan University Hospital1 site in 1 country41 target enrollmentStarted: February 2005Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
41
Locations
1
Primary Endpoint
overall response rate
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

docetaxel and cisplatin

Experimental

docetaxel 36mg/m2 and cisplatin 75mg/m2

Intervention: Docetaxel Plus CDDP (Drug)

Outcomes

Primary Outcomes

overall response rate

Time Frame: every cycle during 2nd-6th cycles

Secondary Outcomes

  • resectability(resectability after treatment)
  • progression free survival(progression free survival after 1 year)
  • overall survival(overall survival at 1 year)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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