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Phase II trial of S-1 plus Cetuximab combination therapy in patients inappropriate for platinum-based therapy with recurrent/metastatic squamous cell carcinoma of the head and neck

Phase 2
Conditions
Recurrent/metastatic squamous cell carcinoma of the head and neck
Registration Number
JPRN-UMIN000015123
Lead Sponsor
Hokkaido University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
21
Inclusion Criteria

Not provided

Exclusion Criteria

(1)History of severe hypersensitivity (2)Active infection (3)Severe and uncontrolled complication(severe heart failure, cerebrovascular disease, pulmonary fibrosis, renal failure, liver failure, active peptic ulcer, uncontrolled diabetes mellitus, uncontrolled hypertention, etc.) (4)Uncontrolled pleural, pericardial effusion or ascites (5)Symptomatic brain metastasis (6)Simultaneous or metachronous double cancers within the past 5 years other than skin cancer (malignant melanoma is excluded), carcinoma in situ of uterine cervix and mucosal carcinoma of digestive tract (7)Receiving flucytocine (8)HBs Ag positive (9)Pregnant or lactating women or women of childbearing potential and men in hope of the pregnancy of the partner (10)Unstable psychiatric disease (11)Surgery or radiotherapy within 4 weeks (12)Decision of ineligibility by a physician

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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