NCT04277858 Neoadjuvant Chemotherapy and Transoral Robotic Surgery for Oropharyngeal Cancer.
| NCT ID | NCT04277858 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Nader Sadeghi |
| Condition | Oropharynx Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2018-08-14 |
| Primary Completion | 2024-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2018-08-14 with a primary completion date of 2024-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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
Contact & Investigator
Nader Sadeghi, MD
STUDY CHAIR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Frequently Asked Questions
Who can join the NCT04277858 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Oropharynx Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04277858 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04277858 currently recruiting?
Yes, NCT04277858 is actively recruiting participants. Contact the research team at nader.sadeghi@mcgill.ca for enrollment information.
Where is the NCT04277858 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT04277858 clinical trial?
NCT04277858 is sponsored by Nader Sadeghi. The principal investigator is Nader Sadeghi, MD at McGill University Health Centre/Research Institute of the McGill University Health Centre. The trial plans to enroll 60 participants.
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