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 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT01507467
Eligibility Criteria:
Inclusion Criteria:
* Tumor classified as stage I-IV located in oropharynx, hypopharynx, larynx (not glottic stage I-II), or oral cavity according to the TNM classification.
* Histopathological diagnosis of invasive squamous cell carcinoma in the primary tumor.
* Informed consent according to the Helsinki declaration and local regula-tions.
* The patient must be candidate for external beam radical radiotherapy, and must be expected to accomplish the treatment.
* Performance status 0-2 according to WHO criteria.
* The patient should not have symptoms of peripheral neuropathy assessed by clinical examination.
* Normal function of liver and kidney by routine laboratory examinations. The patient must not be pregnant
Exclusion Criteria:
* Distant metastases.
* The patient should not be in a state or condition that could be expected to influence the outcome of treatment, or complicate the assessment or the treatment follow-up, or (apart from the present disease) reduce the life expectancy.
* Surgical excision (except biopsy), prior or planned (including elective neck dissection).
* The existence of synchronous multiple malignancies (not leukoplakia).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01507467
Study Brief:
Protocol Section:
NCT01507467