NCT00172380

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2005

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

December 20, 2012

Status Verified

December 1, 2012

Enrollment Period

4.9 years

First QC Date

September 12, 2005

Last Update Submit

December 19, 2012

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

  • overall response rate

    every cycle during 2nd-6th cycles

Secondary Outcomes (3)

  • resectability

    resectability after treatment

  • progression free survival

    progression free survival after 1 year

  • overall survival

    overall survival at 1 year

Study Arms (1)

docetaxel and cisplatin

EXPERIMENTAL

docetaxel 36mg/m2 and cisplatin 75mg/m2

Drug: Docetaxel Plus CDDP

Interventions

Docetaxel Plus CDDPDRUG

docetaxel 36mg/m2 and cisplatin 75mg/m2

docetaxel and cisplatin

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine, National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Interventions

Docetaxel

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Chong-Jen Yu, M.D,Ph.D.

    Department of Internal Medicine, National Taiwan University hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

February 1, 2005

Primary Completion

January 1, 2010

Study Completion

March 1, 2010

Last Updated

December 20, 2012

Record last verified: 2012-12

Locations

TW(1)