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 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT04651634
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed HNSCC (The American joint committee on cancer \[AJCC\] 8th edition, Stage II, III, IVA, or IVB), involving either the oral cavity or oropharynx, or HPV-positive Stage I oropharyngeal cancer.
* Treatment plan to receive a continuous course of intensity-modulated radiation therapy (IMRT) for definitive treatment of HNSCC delivered as single daily fractions of 1.8 to 2.5 Gy with a cumulative radiation dose between 60 and 72 Gy (EQD2 of 60 to 72 Gy, α/β ratio=10): Planned radiation treatment fields must include at least 30% of oral cavity that are planned to receive a total of 50 Gy or higher.
* CCRT plan to receive standard cisplatin monotherapy: Standard cisplatin monotherapy administered weekly (30 to 40 mg/m2), once per week for 5 to 7 continuous weeks.
* Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 1 or less
* Serum pregnancy test negative for women of childbearing potential (woman of childbearing potential \[WOCBP\]
Exclusion Criteria:
* Patients who have active mucositis at screening.
* Planned to receive Erbitux™ (Cetuximab) or other targeted or immune therapy during the study.
* Tumor of the lips, sinuses, or salivary glands or unknown primary tumors.
* Metastatic disease (M1) Stage.
* Known history of severe vascular toxicity or allergies or intolerance to cisplatin and similar platinum-containing compounds.
* Any clinically significant and/or active infection, other systemic illness or condition (other than HNSCC) that would preclude them from participating in the study in the opinion of the Investigator.
* Prior resective surgery (4 weeks or less than 4 weeks from receiving surgery to randomization) for primary tumor under treatment for HNSCC.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04651634
Study Brief:
Protocol Section:
NCT04651634