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OncoMatch/Clinical Trials/NCT04277858

Neoadjuvant Chemotherapy and Transoral Robotic Surgery for Oropharyngeal Cancer.

Is NCT04277858 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Docetaxel for oropharynx cancer.

Phase 2RecruitingNader SadeghiNCT04277858Data as of May 2026

Treatment: DocetaxelThe 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.

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Extracted eligibility criteria

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

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

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.

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