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 @ 4:31 AM
Ignite Modification Date:
2025-12-25 @ 4:31 AM
NCT ID:
NCT03396718
Eligibility Criteria:
Inclusion Criteria:
* Condition after surgical removal of a squamous cell carcinoma of the oropharynx and adequate lymph node dissection
* Indication for adjuvant radiotherapy or radiochemotherapy in the interdisciplinary tumor board
* Good general state (ECOG performance status 0 or 1)
* Adequate compliance to ensure closely follow-up
* Patient's consent and written consent
* Neck dissection of at least the tumor bearing side
Additional Inclusion Criteria Arm intermediate risk (at least one of the criteria must be fulfilled):
* pT3 and R0 and / or
* histologically confirmed involvement of lymph nodes (n = 1-3) and no extracapsular extension of the lymph node metastasis
Additional Inclusion Criteria Arm high risk (at least one of the criteria must be fulfilled):
* residual tumor (R1 status) and / or
* pathologic stage T4 (pT4) status and / or
* more than 3 infected lymph nodes and / or
* extracapsular extension of at least one lymph node metastasis
Exclusion Criteria:
* Patients with a cumulative nicotine abuse \> 30 packyears. These patients are not included in the intervention arms, but are always included in the observation arms (regardless of HPV status).
* radiologically presumed or histologically confirmed distant metastasis
* R2 resection or macroscopically visible residual tumor after surgery
* no neck dissection
* interval between last operation and planned irradiation start \> 7 weeks
* contraindication against a guideline-appropriate adjuvant radiation or radiochemotherapy according to the clinical risk constellation
* tumor disease in the last five years before the beginning of the study (except basaliomas of the skin, in-situ carcinoma of the cervix uteri or breast, or tumors with similar prognosis which are considered to be very likely to be cured)
* malignant tumor disease in the head and neck region, regardless of interval and prognosis
* Pre-irradiation with risk of dose overlap
* participation in another clinical trial if further experimental therapy is necessary or the treatments/ protocols are mutually exclusive (e.g. altered chemotherapy, additional consolidation chemotherapy). Allowed is the additional participation in observation studies or supportive therapy studies.
* diseases or conditions which do not allow the person concerned to assess the nature and scope and possible consequences of the clinical trial
* pregnant or lactating women
* evidence that the participant is not expected to comply with the study protocol (e.g. lack of cooperation)
* missing written consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03396718
Study Brief:
Protocol Section:
NCT03396718