Actively Recruiting
Neoadjuvant Chemotherapy and Transoral Robotic Surgery for Oropharyngeal Cancer.
Led by Nader Sadeghi · Updated on 2023-10-23
60
Participants Needed
1
Research Sites
419 weeks
Total Duration
On this page
Sponsors
N
Nader Sadeghi
Lead Sponsor
M
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant Chemotherapy and Transoral Robotic Surgery for Oropharyngeal Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Squamous cell cancer of oropharynx, p16 positive
- Stage III (T1N1, T2N1, T3N0, T3N1) or Stage IVa (T1N2, T2N2, T3N2) based on AJCC-7
- No prior treatment for this cancer
- No distant metastatic disease
- Suitable for surgery with tumor resectable by transoral approach with clear margins
- Age over 18 years
- Karnofsky performance status over 60% or ECOG less than 2
- Absolute neutrophil count over 2,000, platelets over 100,000, and creatinine clearance over 50 cc/min
- Signed study consent form
- No other cancers except basal cell or squamous cell skin cancer within last 5 years
- Willing to use effective contraception; women of childbearing potential must have negative pregnancy test and not be breastfeeding
You will not qualify if you...
- Advanced T4 cancer not resectable without organ preservation
- Tumor that is p16 negative
- N3 disease (Stage IVB AJCC-7)
- Five or more positive cervical lymph nodes
- Distant metastatic disease (Stage IVC)
- Radiological signs of gross extracapsular nodal tumor invasion
- Anatomy preventing transoral surgical access
- Prior head and neck cancer except certain skin cancers
- Another active or recent malignancy within 5 years except certain early cancers
- Peripheral neuropathy grade 1 or higher
- Previous treatment with Taxanes or Cisplatin
- Current infection
- Serious medical illness that may interfere with treatment or consent
- Receiving other investigational treatments during the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
Research Team
N
Nader Sadeghi, MD
CONTACT
E
Elizabeth Beaubien
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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