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 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT04277858
Eligibility Criteria:
Inclusion Criteria:
* Squamous cell cancer of oropharynx, p 16 positive
* American Joint Commission on Cancer version-7 (AJCC-7) Stage III (T1N1, T2N1, T3N0, T3N1) and stage IVa (T1N2, T2N2, T3N2)
* Treatment Naive
* No evidence of distant metastatic disease
* Fit for surgery, and primary tumor assessed surgically resectable with negative margins via transoral approach
* Age \> 18 years
* Karnofsky performance status \> 60% or Eastern Cooperative Oncology Group (ECOG) \< 2
* Absolute neutrophil count (ANC) \> 2,000, platelets \> 100,000 and calculated creatinine clearance \> 50 cc/min
* Signed study specific consent form
* No other malignancies except cutaneous basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) within the last 5 years
* Agree to use effective contraception while on the study. Women of child bearing potential must have a negative pregnancy test, and not be lactating.
Exclusion Criteria:
* Patients with advanced T4 cancer unresectable without organ preservation
* P16 negative tumor
* N3 disease (Stage IVB AJCC-7)
* 5 or more positive cervical lymph nodes at presentation
* Distant metastatic disease (Stage IVC)
* Radiological evidence of gross extracapsular nodal tumor invasion
* Anatomy not allowing transoral access and exposure
* Prior head and neck cancer at any time (Other than BCC or SCC of skin)
* Coexistent second malignancy or history within 5 years of prior malignancy (other than BCC or early SCC skin or curatively treated Stage I carcinoma of cervix)
* Peripheral neuropathy \>/= grade 1
* Have had prior Taxanes or Cisplatin
* Concurrent infection
* Coexisting medical illness of a severity that might interfere with treatment or follow-up, or who do not have the ability to give informed consent.
* Receiving any other investigational agent while on the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04277858
Study Brief:
Protocol Section:
NCT04277858