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 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT01216020
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed squamous cell carcinoma (with biopsy on the primary and / or lymph node metastases) of the oral cavity, oropharynx, hypopharynx, larynx supraglottix;
* Locally advanced disease, defined by one of the following criteria: any T, N +, M0 (excluding T1, N1), T3-4, N0, M0;
* Not cancer nasopharynx or paranasal sinuses or salivary glands;
* General conditions and associated diseases which does not allow to perform chemotherapy or radiotherapy in a radical view;
* No other surgical treatments, chemotherapy or radiotherapy for cancer of head and neck or elsewhere, except non-melanoma skin cancer or in situ cervical cancer and other solid tumors for which radical treatment has been completed \> three years prior to enrollment in the study and for which the patient has remained continuously free of disease;
* Accessibility to follow-up;
* Signing of informed consent;
* Interval between examinations of local staging and randomization, maximum 3 weeks
* Interval between randomization and initiation of treatment, maximum 2 weeks
Exclusion Criteria:
* Age \<18 years
* ECOG performance status \> 0-1
* Hemoglobin \<9 g / dL
* Counts of granulocytes, total \<1.5 x 10 \^ 9 / L
* Platelet count \<100 x 10 \^ 9 / L
* Bilirubin\> 1.5 times upper limit of normal (ULN)
* AST or ALT\> 3 times ULN
* Creatinine clearance \> 50 mL/min
* Mg \> 0.5 mmol/L
* Pregnancy or lactation
* Presence of allergy to study drug or to the excipients used in their formulation
* Peripheral neuropathy ≥ grade 2 (CTCAE v3.0)
* Hearing loss / tinnitus ≥ grade 3 (CTCAE v3.0)
* One of the following conditions:
* Myocardial infarction within 12 months prior to randomization
* Severe congestive heart failure
* Unstable angina
* Cardiomyopathy in act
* Ventricular arrhythmia
* uncontrolled hypertension
* Severe psychotic disorders in act
* Severe infection in act
* Any other serious illness that could interfere with the administration of the therapy provided by the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01216020
Study Brief:
Protocol Section:
NCT01216020