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Phase II Study of Docetaxel Plus CDDP for NSCLC Stage III

Primary Purpose

NSCLC

Status

Completed

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

Docetaxel Plus CDDP

About this trial

This is an interventional treatment trial for NSCLC

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Internal Medicine, National Taiwan University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

docetaxel and cisplatin

Arm Description

docetaxel 36mg/m2 and cisplatin 75mg/m2

Outcomes

Primary Outcome Measures

overall response rate

Secondary Outcome Measures

resectability

progression free survival

overall survival

Full Information

NCT ID

NCT00172380

First Posted

September 12, 2005

Last Updated

December 19, 2012

Sponsor

National Taiwan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00172380

Brief Title

Phase II Study of Docetaxel Plus CDDP for NSCLC Stage III

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 Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Completed

Study Start Date

February 2005 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Taiwan University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

NSCLC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

docetaxel and cisplatin

Arm Type

Experimental

Arm Description

docetaxel 36mg/m2 and cisplatin 75mg/m2

Intervention Type

Drug

Intervention Name(s)

Docetaxel Plus CDDP

Intervention Description

docetaxel 36mg/m2 and cisplatin 75mg/m2

Primary Outcome Measure Information:

Title

overall response rate

Time Frame

every cycle during 2nd-6th cycles

Secondary Outcome Measure Information:

Title

resectability

Time Frame

resectability after treatment

Title

progression free survival

Time Frame

progression free survival after 1 year

Title

overall survival

Time Frame

overall survival at 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chong-Jen Yu, M.D,Ph.D.

Organizational Affiliation

Department of Internal Medicine, National Taiwan University hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Internal Medicine, National Taiwan University Hospital

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

12. IPD Sharing Statement

Learn more about this trial

Phase II Study of Docetaxel Plus CDDP for NSCLC Stage III

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