Multicenter phase I trial of outpatient chemotherapy with docetaxel and nedaplatin for oral squamous cell carcinoma

UMIN ID: UMIN000001860

Registered date:08/04/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Oral squamous cell carcinoma
• Date of first enrollment: 2008/04/01
• Target sample size: 18
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Docetaxel is administered intravenously for 1 h on day1. After completion of the docetaxel infusion, nedaplatin is administered intravenously for another hour followed by 1,000 ml or more hydration. The dose levels of biweekly chemotherapy with docetaxel and nedaplatin are 30/40, 30/50, and 35/50 (mg/m2).

Outcome(s)

• Primary Outcome: Safety of outpatient chemotherapy with docetaxel and nedaplatin for patients with unresectable or recurrent oral squamous cell carcinoma
• Secondary Outcome: Clinical and histopathological effect of outpatient chemotherapy with docetaxel and nedaplatin for patients with unresectable or recurrent oral squamous cell carcinoma

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-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: Chubu research group on oral cancer