OncoMatch/Clinical Trials/NCT04277858
Neoadjuvant Chemotherapy and Transoral Robotic Surgery for Oropharyngeal Cancer.
Is NCT04277858 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Docetaxel for oropharynx cancer.
Treatment: Docetaxel — The objective of this trial is to study the efficacy of treatment of human papilloma virus (HPV) related oropharyngeal cancer with chemotherapy followed by Transoral Robotic Surgery (TORS) as definitive treatment. Current treatment of oropharyngeal cancer are chemo-radiotherapy. There is significant lifelong side effects associated with this approach related to tissue effects of radiotherapy. The side effects results in significant quality of life deterioration among the patients. Overall there is 20% failure rate with this treatment approach. The study hypothesis is that treatment with upfront (neoadjuvant) chemotherapy followed by transoral surgery and neck dissection is highly effective treatment allowing competitive cure rate compared to chemo-radiotherapy with less than 10% failure rate, while avoiding radiotherapy in majority of cases. It is also hypothesized that better functional and quality of life outcome maybe achieved with this approach.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: CDKN2A p16 positive (positive)
Disease stage
Required: Stage III, IVA
Excluded: Stage IVB, IVC
Demographics
Prior therapy
Cannot have received: taxane
Have had prior Taxanes or Cisplatin
Cannot have received: platinum-based chemotherapy (cisplatin)
Have had prior Taxanes or Cisplatin
Cannot have received: head and neck cancer therapy
Exception: BCC or SCC of skin
Prior head and neck cancer at any time (Other than BCC or SCC of skin)
Lab requirements
Blood counts
anc > 2,000, platelets > 100,000
Kidney function
calculated creatinine clearance > 50 cc/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT04277858 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require CDKN2A?
Yes, CDKN2A p16 positive is a required biomarker for enrollment.
What disease stage is eligible?
Stage III or IVA is required.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages