| Title |
Phase II Study: Induction Chemotherapy Followed by Transoral Robotic Surgery and Neck Dissection for Definitive Management of Oropharyngeal Squamous Cell Carcinoma. |
| Protocole ID |
NECTORS Trial |
| ClinicalTrials.gov ID |
NCT04277858 |
| Cancer Type(s) |
Head and Neck |
| Phase |
Phase II |
| Stage |
|
| Study Type |
Treatment |
| Drug |
Docétaxel suivi d'une chirurgie |
| Institution |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
 SITE GLEN
1001 boul. Décarie , Montréal, QC, H4A 3J1
|
| City |
|
| Principal Investigator |
Dr. Nader Sadeghi
|
| Coordinator |
Elizabeth Beaubien
514-934-1934 pose 34974
|
| Status |
Recruiting |
| Activation Date |
|
| Eligibility 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
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Groupe d'étude en oncologie du Québec