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:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT02765503
Eligibility Criteria:
Inclusion Criteria:
1. Tumor classified as stage I-IV located in oropharynx, hypopharynx, larynx (not glottic stage I-II), or oral cavity according to the TNM classification
2. Histopathological diagnosis of invasive squamous cell carcinoma at the primary site
3. Age \> 18 years
4. Informed consent according to the Helsinki declaration and local regulations
5. The patient must be a candidate for external beam radical radiotherapy, and must be expected to complete the treatment
6. WHO performance status of 0-2
7. For patients receiving concomitant chemotherapy: Normal CBC and normal function of liver and kidney by routine laboratory examinations.
Impaired function of liver is defined as elevation of liver enzymes by 2.5 times the upper limit of the normal reference value for the institution and of kidney as serum creatinine by 1.5 times the upper limit of the normal reference value for the institution by routine laboratory examinations or creatinine clearance level less than 50 ml/min
Exclusion Criteria
1. Distant metastases
2. The patient should not be in a state or have major co-morbidity that could be expected to influence the outcome of treatment, or interfere with the assessment of treatment outcome at follow-up, or (apart from the present disease) considerably reduce the life expectancy
3. Patients who test positive for human immunodeficiency virus (HIV)
4. Prior surgical excision (except biopsy)
5. Planned (elective) surgery
6. The existence of synchronous multiple malignancies (not leukoplakia) or previous history of cancer
7. The patient must not be pregnant
8. Socio-demographic or other factors that make it unlikely that the patient will be available for follow up of long term treatment outcome
3.5. Additional criterion for patients receiving chemotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02765503
Study Brief:
Protocol Section:
NCT02765503