Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Base of the Tongue Carcinoma | Posterior Tongue Carcinoma | ALIAS | 0.90 |
| Oropharynx Cancer | Malignant Oropharyngeal Neoplasm | ALIAS | 0.90 |
| Throat Cancer | Throat Carcinoma | ALIAS | 0.90 |
| Tonsil Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant chemotherapy and surgery
- description
- Docetaxel and Cisplatin x 3 cycles followed by Transoral robotic surgery and neck dissection. Carboplatin may be used instead of Cisplatin.
- interventionNames
- Drug: Docetaxel
Primary outcomes (1)
- measure
- Primary outcome: progression free survival.
- timeFrame
- 2 years
- description
- Subjects will be evaluated for cancer recurrence or persistence. Index cancer recurrence or persistence following completion of treatment at any site will be recorded as an event. Progression free survival will be calculated at 2 years according to the Kaplan Meier methods.
Secondary outcomes (4)
- measure
- Disease Specific Survival (DSS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDSadeghi N, Mascarella MA, Khalife S, Ramanakumar AV, Richardson K, Joshi AS, Taheri R, Fuson A, Bouganim N, Siegel R. Neoadjuvant chemotherapy followed by surgery for HPV-associated locoregionally advanced oropharynx cancer. Head Neck. 2020 Aug;42(8):2145-2154. doi: 10.1002/hed.26147. Epub 2020 Mar 25. PMID 32212296
- BACKGROUNDSadeghi N, Khalife S, Mascarella MA, Ramanakumar AV, Richardson K, Joshi AS, Bouganim N, Taheri R, Fuson A, Siegel R. Pathologic response to neoadjuvant chemotherapy in HPV-associated oropharynx cancer. Head Neck. 2020 Mar;42(3):417-425. doi: 10.1002/hed.26022. Epub 2019 Nov 27. PMID 31773857
- BACKGROUNDSadeghi N, Li NW, Taheri MR, Easley S, Siegel RS. Neoadjuvant chemotherapy and transoral surgery as a definitive treatment for oropharyngeal cancer: A feasible novel approach. Head Neck. 2016 Dec;38(12):1837-1846. doi: 10.1002/hed.24526. Epub 2016 Jun 14. PMID 27299983