A randomized controlled Phase II study comparing TS-1 alone with CDDP+TS-1 as postoperative adjuvant chemotherapy in non-small-cell-lung-cancer ; translational research of the chemotherapy effect prediction factor

UMIN ID: UMIN000001658

Registered date:26/01/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Non Small Cell Lung Cancer
• Date of first enrollment: 2007/09/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

TS-1
CDDP,TS-1

Outcome(s)

• Primary Outcome: Relapse-free survival of 2 years, to searches for the chemotherapy effect prediction factor.
• Secondary Outcome: Overall survival (OS), Rate of adverse events, Relative dose intensity, to searches for a prognosis prediction factor.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) clinically significant drug allergy 2) Under treatment with flucytosine, phenytoin, Warfarin Potassium, other trial drugs. 3) The infection which needs the medical treatment by antibiotics, and other serious complications 4) The case which has diarrhea continuously 5) The case which has clear interstitial pneumonia or a clear fibroid lung with a chest simple X ray 6) The case which has malignant tumors other than the lung cancer 7) The case which has the past of a malignant tumor 8) Not suitable for participating in the study for any other reason

Related Information

• Primary Sponsor: West Japan Oncology Group
• Source(s) of Monetary Support: None