Multicenter phase II trial of neoadjuvant chemotherapy with docetaxel and nedaplatin for oral squamous cell carcinoma

UMIN ID: C000000023

Registered date:01/08/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: oral squamous cell carcinoma
• Date of first enrollment: 2004/06/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Docetaxel (60 mg/m2) was administered intravenously for 1 h on day1. After completion of the docetaxel infusion, nedaplatin (100 mg/m2) was administered intravenously for another hour followed by 1,000 ml or more hydration.

Outcome(s)

• Primary Outcome: Clinical and histopathological effect of induction chemotherapy with docetaxel and nedaplatin for resectable oral squamous cell carcinoma
• Secondary Outcome: Safety of induction chemotherapy with docetaxel and nedaplatin for resectable oral squamous cell carcinoma

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: Patients were excluded if they had active infections, active second malignancy, severe heart diseases, interstitial pneumonia or lung fibrosis, severe pleural effusion or pericardial effusion that required drainage, fever more than or equal to 38 C, symptomatic brain metastasis, severe psychological disease, and possible pregnancy.

Related Information

• Primary Sponsor: Chubu research group on oral cancer
• Source(s) of Monetary Support: None