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 @ 12:39 PM
Ignite Modification Date:
2025-12-24 @ 12:39 PM
NCT ID:
NCT05648461
Eligibility Criteria:
Inclusion Criteria:
1. Aged 18 or above and less than 80 years.
2. Patient with high risk features: close (≤ 5mm) margin, presence of LVI or PNI, pT3-4.
3. Stage pT1-4 histological confirmed carcinoma of oral cavity with intermediate high risk feature.
4. Pathological N0 neck requiring ipsilateral neck PORT.
5. Karnofsky performance score greater or equal 70.
6. Timely delivery of PORT preferable within 6-12 weeks of surgery (additional delay of 1-3 weeks of delay beyond 12 weeks is permissible to accommodate for delayed wound healing or other logistics).
7. Written informed consent for treatment.
8. Available to attend long term follow- up.
Exclusion Criteria:
1. Pathologically positive neck disease.
2. Positive margin.
3. Patients requiring bilateral neck RT.
4. Patients that require re-irradiation for recurrent disease.
5. Previous radiotherapy to the head and neck region.
6. Any invasive malignancy within the previous 2 years (other than non melanomatous skin carcinoma or cervical carcinoma in situ).
7. Age \< 18 years or \> 80 years.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05648461
Study Brief:
Protocol Section:
NCT05648461