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:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2025-12-26 @ 10:16 PM
NCT ID:
NCT03689712
Eligibility Criteria:
Inclusion Criteria:
* squamous cell carcinoma of the head and neck
* treatment plan to receive IMRT delivered as single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose of 60-72 Gy
* Treatment plan to receive standard cisplatin monotherapy
* Age 18 years or older
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Adequate hematologic, renal and liver function
* Negative serum pregnancy test
* Use of effective contraception
Exclusion Criteria:
* Tumor of the lips, larynx, hypopharynx, nasopharynx, sinuses, or salivary glands
* Metastatic disease
* Prior radiotherapy to the region of the study cancer or adjacent anatomical
* Prior induction chemotherapy
* Receiving any approved or investigational anti-cancer agent other than those provided for in this study
* Concurrent participation in another interventional clinical study
* Inability to eat soft solid food at baseline
* Malignant tumors other than HNC within the last 5 years
* Active infectious disease excluding oral candidiasis
* Presence of oral mucositis at baseline
* Known history of HIV or active hepatitis B/C
* Female patients who are pregnant or breastfeeding
* Known allergies or intolerance to cisplatin and similar platinum-containing compounds
* Requirement for concurrent treatment with nitrates or other drugs that may create a risk for a precipitous decrease in blood pressure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03689712
Study Brief:
Protocol Section:
NCT03689712