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 @ 2:19 PM
Ignite Modification Date:
2025-12-24 @ 2:19 PM
NCT ID:
NCT01716195
Eligibility Criteria:
Inclusion Criteria:
* Pathologically proven diagnosis of HPV-positive squamous cell carcinoma of the oropharynx, hypopharynx, or larynx. HPV-positivity will be defined as tumors that are p16-positive by immunohistochemistry.
* Clinical stage III or IV disease; Note: Patients with M1 tumors are not eligible.
* Appropriate stage for protocol entry, including no distant metastases, based upon minimum diagnostic workup
* Zubrod Performance Status 0-1
* Age \> 18
* Adequate bone marrow function
* Adequate hepatic function
* Adequate renal function
* Pregnancy test within 4 weeks prior to registration for women of childbearing potential
* Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study (until at least 60 days following the last study treatment)
* Patient must sign study specific informed consent prior to study entry.
Exclusion Criteria:
* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years;
* Patients with simultaneous primaries or bilateral tumors are excluded.
* Patients who present with a cervical lymph node metastasis of unknown primary origin;
* Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable;
* Prior radiotherapy that would result in overlap of radiation therapy fields;
* Primary site of tumor of oral cavity, nasopharynx, nasal cavity, paranasal sinuses, or salivary glands;
* Recurrent head and neck cancer;
* Severe, active co-morbidity
* Pregnant or lactating women or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
* Prior allergic reaction to the study drug(s) involved in this protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01716195
Study Brief:
Protocol Section:
NCT01716195