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 @ 4:01 AM
Ignite Modification Date:
2025-12-25 @ 4:01 AM
NCT ID:
NCT01088802
Eligibility Criteria:
Inclusion Criteria:
* Biopsy-proven SCC of the oropharynx (tonsil, base of tongue, pharyngeal wall or palate).
* Tumor positive for infection with human papilloma virus (HPV) virus.
* T stage: 1, 2 or T3. Surgery of the primary tumor is limited to incisional or excisional biopsies (i.e tonsillectomy) even without macroscopic disease left. Positive resection margins and/or gross residual disease at the primary site are allowed.
* Any N stage, but resectable; lymph nodes in both sides of the neck are at risk of metastatic disease, according to clinical judgment, and require irradiation; pretreatment surgery in the neck in the forms of incisional/excisional biopsy or a multilevel neck dissection is allowed only if there is gross tumor left at the primary site.
* No other malignancy except for non-myelomatous skin cancer, early stage prostate cancer (T\<2a and PSA\<10 and GLS\<7) or a carcinoma not of head and neck origin disease free for \> 5 yrs.
* Cannot have distant metastasis (M0)
* ECOG performance status 0-1.
* Patient's nutritional and general physical condition must be considered compatible with the proposed radiotherapeutic treatment.
* Patient is judged to be mentally reliable to follow instructions and to keep appointments.
* Patient is on no other treatment for head and neck cancer.
* Signed study-specific informed consent prior to registration.
Exclusion Criteria:
* Evidence of distant metastases.
* Absence of macroscopic disease after upfront surgery
* Previous irradiation for head and neck tumor; concurrent chemotherapy other than the treatment per protocol; previous chemotherapy ≤ 3 months from start of RT.
* Active untreated infection.
* Major medical or psychiatric illness, which in the investigators' opinions would interfere with either completion of therapy and follow-up or with full and complete understanding of the risks and potential complications of the therapy.
* Prophylactic use of amifostine or pilocarpine is not allowed.
* Patients with greater than 1- pack years of smoking history and/or currently a smoker at the time of treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT01088802
Study Brief:
Protocol Section:
NCT01088802