Docetaxel and S-1 in Head and Neck Squamous Cell Carcinoma (HNSCC)

Seoul National University

Status and phase: Terminated; Phase 2

Conditions: Head and Neck Squamous Cell Carcinoma

Treatments: Drug: docetaxel+CDDP; Drug: docetaxel+S-1

Study type: Interventional

Funder types: Other

Identifiers

NCT00805012

CRCST-L-0004

Details and patient eligibility

About

To assess response rate of docetaxel and S-1 combination in metastatic or recurrent head and neck squamous cell carcinoma

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histologically confirmed HNSCC
• adequate primary site: oral cavity, oropharynx, hypopharynx, nasal cavity, paranasal sinus, other head and neck site (except nasopharynx)
• at least one measurable lesion
• no previous palliative chemotherapy (adjuvant/neoadjuvant chemotherapy and/or radiotherapy longer than 6 months ago is permitted)
• 18 years or older
• ECOG 0 or 1
• adequate laboratory result
• written, informed consent

Exclusion criteria

• pregnant or lactating women (negative pregnancy test within 7 days is required for women with potential of child-bearing)
• experimental drug clinical trial within 30 days
• other malignancy (exemption: treated basal cell carcinoma of skin, CIS, cured cancer with disease-free interval with more than 5 years)
• patient with organ transplantation
• grade 2 or more peripheral neuropathy
• grade 2 or more hearing loss
• severe, medical condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

1

Active Comparator group

Description:

docetaxel+CDDP

Treatment:

Drug: docetaxel+CDDP

2

Experimental group

Description:

docetaxel+S-1

Treatment:

Drug: docetaxel+S-1