Oropharynx Cancer Clinical Trial
— NECTORSOfficial title:
Phase II Study: Induction Chemotherapy Followed by Transoral Robotic Surgery and Neck Dissection for Definitive Management of Oropharyngeal Squamous Cell Carcinoma. (NECTORS Trial)
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | August 30, 2026 |
Est. primary completion date | August 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | McGill University Health Centre | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Nader Sadeghi | McGill University Health Centre/Research Institute of the McGill University Health Centre |
Canada,
Sadeghi 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. — View Citation
Sadeghi 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. — View Citation
Sadeghi 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary outcome: progression free survival. | 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. | 2 years | |
Secondary | Disease Specific Survival (DSS) | The trial subjects will be followed for vital statistics (dead or alive) from the time enrolled in the trial. Any deaths that is caused by the index cancer will count as an event. DSS will be calculated with intention to treat analysis according to the Kaplan Meier methods at 5 years. | 5 years | |
Secondary | Overall Survival (OS) | The trial subjects will be followed for vital statistics (dead or alive) from the time of enrolment. Death from any cause will be counted as an event. Overall survival will be calculated according to the Kaplan Meier methods at years. | 5 years | |
Secondary | General Quality of Life (QOL) | Patient-reported general quality of life outcome will be measured according to The European Organization for Research and Treatment of Cancer (EORTC) general quality of life questionnaire (EORTC QLQ-C30) at 3 month, 6 months, and 12 months following the completion of treatment. These questionnaires are validated and an integrated system for assessing the quality of life (QoL) of cancer patients participating in clinical trials. Outcome score for functional scales at 12 months will be compared to pretreatment levels. | 12 months. | |
Secondary | Head and Neck Specific Quality of Life (QOL) | Patient-reported quality of life outcome will be measured according to EORTC head and neck specific questionnaire (QLQ-H&N35) prior to trial treatment (baseline), at 3 month, 6 months, and 12 months following the completion of treatment. These questionnaires are validated and an integrated system for assessing the quality of life (QoL) of head and neck cancer patients participating in clinical trials. Outcomes for symptom scales in H&N-35 at 12 months will be compared to pretreatment levels. | 12 months |
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