Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-25 @ 1:47 AM
NCT ID:
NCT01434394
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent prior to any study activities
* Age 18-75
* Histological/cytological and iconography confirmed squamous-celled oral/oropharyngeal cancer
* Stage Ⅲ/Ⅳa (T1-2, N1-2, M0 or T3-4, N0-2, M0, AJCC 2010), operable disease
* Karnofsky performance status (KPS) ≥70
* Adequate hematologic function: Neutrophils ≥1,500/mm\^3, WBC \>4,000/mm\^3, Hb \> 10 g/dL, platelet count \>100,000/mm\^3
* Hepatic function: ALAT/ASAT \<2.5 times the upper limit of normal (ULN), bilirubin \<1.5 x ULN
* Renal function: serum creatinine \<1.5 x ULN
* Life expectancy ≥6 months
Exclusion Criteria:
* Evidence of distant metastatic disease and other oropharyngeal cancers
* Surgical procedure of the primary tumor or lymph nodes (except diagnostic biopsy) before study treatment
* Previous radiotherapy for the primary tumor or lymph nodes
* Previous exposure to epidermal growth factor-targeted therapy
* Prior chemotherapy or immunotherapy for the primary tumor
* Other previous malignancy within 5 years, except non-melanoma skin cancer or pre-invasive carcinoma of the cervix
* Any investigational agent prior to the 1st study medication
* Participation in another clinical study within the 30 days prior to Inclusion in this study.
* Peripheral neuropathy \>grade 1
* Known grade 3 or 4 allergic reaction to any of the study treatment
* History of severe pulmonary or cardiac disease
* Creatinine Clearance \<30 ml/min
* Know drug abuse /alcohol abuse
* Legal incapacity or limited legal capacity
* Active systemic infection
* Medical or psychiatric illness, which in the investigators' opinions, would not permit the subject to complete or fully and completely understand the risks and potential complications of the study
* Concurrent chronic systemic immune therapy or hormone therapy not indicated in the study protocol
* Pregnancy (confirmed by serum or urine β-HCG) or lactation period
* Severe cardiac disease such as heart failure, clinical relevant cardiac dysrhythmias, coronary artery disease or myocardial infarction within the last 12 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01434394
Study Brief:
Protocol Section:
NCT01434394