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Completed

NCT Number: NCT00172380

Phase II Study of Docetaxel Plus CDDP for NSCLC Stage III

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.

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Key information

Conditions

NSCLC

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Internal Medicine, National Taiwan University Hospital

Taipei, 100, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Docetaxel Plus CDDP

Drug

docetaxel 36mg/m2 and cisplatin 75mg/m2

Primary outcomes

  1. overall response rate

    Time frame: every cycle during 2nd-6th cycles

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Sep 15, 2005
Registry last updated
Dec 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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