Phase II Study of Docetaxel Plus CDDP for NSCLC Stage III

This study is currently recruiting participants.

Verified by National Taiwan University Hospital, July 2005

First Received: September 12, 2005 Last Updated: November 23, 2005 History of Changes

Sponsored by:	National Taiwan University Hospital
Information provided by:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00172380

Purpose

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.

Condition	Intervention	Phase
NSCLC	Drug: Docetaxel Plus CDDP	Phase II

MedlinePlus related topics: Surgery

Drug Information available for: Docetaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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

Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment:	55
Study Start Date:	February 2005
Estimated Study Completion Date:	August 2005

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00172380

Contacts

Contact: Yung-chie Lee, M.D.,Ph.D.

886-2 ext 5070

wuj@ha.mc.ntu.edu.tw

Locations

Taiwan
Department of Oncology, Nationa Taiwan University Hospital	Recruiting
Taipei, Taiwan, 100
Contact: yung-chie Lee, M.D.,Ph.D. 886-2-23123456 ext 5070 wuj@ha.mc.ntu.edu.tw
Principal Investigator: Yung-Chie Lee, M.D.,Ph.D.

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

Principal Investigator:

Yung-chie Lee, M.D,Ph.D.

Department of Surgery, National Taiwan University hospital

More Information

No publications provided

Study ID Numbers:	930911
Study First Received:	September 12, 2005
Last Updated:	November 23, 2005
ClinicalTrials.gov Identifier:	NCT00172380 History of Changes
Health Authority:	Taiwan: Department of Health

Study placed in the following topic categories:

Docetaxel
Adjuvants, Immunologic
Non-small Cell Lung Cancer

Additional relevant MeSH terms:

Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009