Status:
RECRUITING
Neoadjuvant Chemotherapy and Transoral Robotic Surgery for Oropharyngeal Cancer.
Lead Sponsor:
Nader Sadeghi
Collaborating Sponsors:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
Oropharynx Cancer
Tonsil Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 definiti...
Detailed Description
The current standard of care for advanced (AJCC-7 edition stage III and IV) oropharyngeal squamous cell carcinoma are concomitant chemoradiation, or surgery followed by adjuvant radiation therapy with...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04277858
Start Date
August 14 2018
End Date
August 30 2026
Last Update
October 23 2023
Active Locations (1)
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1
McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1