RecruitingPhase 2NCT04277858

Neoadjuvant Chemotherapy and Transoral Robotic Surgery for Oropharyngeal Cancer.

Phase II Study: Induction Chemotherapy Followed by Transoral Robotic Surgery and Neck Dissection for Definitive Management of Oropharyngeal Squamous Cell Carcinoma. (NECTORS Trial)

Sponsor

Nader Sadeghi

Enrollment

60 participants

Start Date

Aug 14, 2018

Study Type

INTERVENTIONAL

Conditions

Throat Cancer Oropharynx Cancer Tonsil Cancer Base of the Tongue Carcinoma

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is for people with a specific type of throat cancer (HPV-related squamous cell cancer of the oropharynx) at a certain stage. It tests whether giving chemotherapy first, followed by minimally invasive robotic surgery, can effectively treat the cancer while preserving swallowing and speech function. **You may be eligible if...** - You have been diagnosed with HPV-positive oropharyngeal squamous cell cancer (a type of throat cancer) - Your cancer is at stage III or IVa and has not been previously treated - There is no evidence of cancer spread to distant organs - Surgeons believe the tumor can be removed with robot-assisted mouth surgery - You are 18 or older and in reasonably good health **You may NOT be eligible if...** - You have already received treatment for this cancer - Cancer has spread to distant parts of the body - You are unable to tolerate surgery or chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDocetaxel

Subjects will be treated with neoadjuvant docetaxel and cisplatin for 3 cycles. This is followed by transoral robotic surgery (TORS) and neck dissection as definitive treatment, reserving radiotherapy for salvage.