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 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
NCT ID:
NCT02059668
Eligibility Criteria:
Inclusion Criteria:
Primary radiochemotherapy:
* Patients with locally advanced squamous cell carcinoma of the oral cavity, oropharynx or hypopharynx
* Stage III or IV without distant metastases
* Patient is able to participate in regular tumor follow-up care
* planned irradiation dose 69-72 Gy
* planned overall treatment time 38-54 days
* written informed consent of the patient
* general condition according to WHO 0-2
* planned simultaneous chemotherapy with cisplatin (cumulative planned total dose minimum 180 mg/m2 body surface, divided in several separately doses)
Adjuvant radiochemotherapy:
* Patients with locally advanced squamous cell carcinoma of the oral cavity, oropharynx or hypopharynx
* surgery, existence of one or more of the following risk factors for local recurrence:
* extracapsular growth of a minimum of one lymph node metastasis
* R1 resection
* pT4 tumor and more than 3 affected lymph nodes
* Patient is able to participate in regular tumor follow-up care
* planned irradiation dose 63-66 Gy
* planned overall treatment time 44-48 days
* planned simultaneous chemotherapy with cisplatin (cumulative planned total dose minimum 200 mg/m2 body surface, divided in several separately doses)
* written informed consent of the patient
* general condition according to WHO 0-2
* time since last surgery \<56 days (8 weeks)
Exclusion Criteria:
Primary radiochemotherapy:
* distant metastasis
* contraindication against a cisplatin-based chemotherapy
* planned total irradiation dose \<69 Gy and \>72 Gy
* planned overall treatment time \>54 days or \<38 days
* Patient is incapable of giving consent
* previous radiotherapy in the head and neck area, if there is a risk for overlapping of the irradiation areas
* other tumor diseases, which currently need a treatment or probably within the next two years or which influence the prognosis of the patient
* tumor-independent diseases or conditions which reduce the survival probability of the patient to \<2 years or which affect the follow-up over 2 years
* no written informed consent
* induction chemotherapy
* pregnancy or lactation
Adjuvant radiochemotherapy:
* distant metastasis
* contraindication against a cisplatin-based chemotherapy
* planned total irradiation dose \< 63 Gy or \> 66 Gy
* planned overall treatment time \> 48 days or \< 44 day
* Patient is incapable of giving consent
* previous radiotherapy in the head and neck area, if there is a risk for overlapping of the irradiation areas
* other tumor diseases, which currently need a treatment or probably within the next two years or which influence the prognosis of the patient
* tumor-independent diseases or conditions which reduce the survival probability of the patient to \<2 years or which affect the follow-up over 2 years
* no written informed consent
* pregnancy or lactation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02059668
Study Brief:
Protocol Section:
NCT02059668