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Phase II Study of Docetaxel Plus CDDP for NSCLC Stage III

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00172380
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : December 20, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
NSCLC Drug: Docetaxel Plus CDDP Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2005
Primary Completion Date : January 2010
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: docetaxel and cisplatin
docetaxel 36mg/m2 and cisplatin 75mg/m2
Drug: Docetaxel Plus CDDP
docetaxel 36mg/m2 and cisplatin 75mg/m2



Primary Outcome Measures :
  1. overall response rate [ Time Frame: every cycle during 2nd-6th cycles ]

Secondary Outcome Measures :
  1. resectability [ Time Frame: resectability after treatment ]
  2. progression free survival [ Time Frame: progression free survival after 1 year ]
  3. overall survival [ Time Frame: overall survival at 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00172380


Locations
Taiwan
Department of Internal Medicine, National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Chong-Jen Yu, M.D,Ph.D. Department of Internal Medicine, National Taiwan University hospital

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00172380     History of Changes
Other Study ID Numbers: 930911
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: December 20, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Docetaxel
Cisplatin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action