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Phase II Study of Docetaxel Plus CDDP for NSCLC Stage III

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00172380
First received: September 12, 2005
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • overall response rate [ Time Frame: every cycle during 2nd-6th cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • resectability [ Time Frame: resectability after treatment ] [ Designated as safety issue: No ]
  • progression free survival [ Time Frame: progression free survival after 1 year ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: overall survival at 1 year ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: February 2005
Study Completion Date: March 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: docetaxel and cisplatin
docetaxel 36mg/m2 and cisplatin 75mg/m2
 Drug: Docetaxel Plus CDDP
docetaxel 36mg/m2 and cisplatin 75mg/m2

  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

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
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00172380     History of Changes
Other Study ID Numbers: 930911
Study First Received: September 12, 2005
Last Updated: December 19, 2012
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
 Respiratory Tract Diseases
Docetaxel
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013