Chemotherapy followed by robotic surgery for HPV-related throat cancer
Phase II Study: Induction Chemotherapy Followed by Transoral Robotic Surgery and Neck Dissection for Definitive Management of Oropharyngeal Squamous Cell Carcinoma. (NECTORS Trial)
This study is testing if giving chemotherapy before robotic surgery can help people with HPV-related throat cancer have better treatment results and fewer side effects.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT04277858 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of neoadjuvant chemotherapy using Docetaxel followed by Transoral Robotic Surgery (TORS) for patients with HPV-related oropharyngeal cancer. The goal is to improve treatment outcomes while minimizing the long-term side effects associated with traditional chemoradiotherapy. By focusing on surgical resection after chemotherapy, the study aims to achieve a lower failure rate and better quality of life for patients. Participants must have stage III or IVa squamous cell carcinoma of the oropharynx and be fit for surgery.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with treatment-naive, HPV-positive squamous cell carcinoma of the oropharynx at stage III or IVa.
Not a fit: Patients with unresectable advanced T4 cancer or those with distant metastatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce treatment-related side effects and improve the quality of life for patients with oropharyngeal cancer.
How similar studies have performed: While traditional approaches have shown significant side effects, this novel approach combining chemotherapy with robotic surgery is being explored for the first time in this context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Montreal, Quebec
- McGill University Health Centre — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Nader Sadeghi, MD
- Email: nader.sadeghi@mcgill.ca
- Phone: 514-934-1934
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.