Chemotherapy + Robotic Surgery for Throat Cancer (NECTORS Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Nader Sadeghi
Stay on your current meds
No Placebo Group
Prior Safety Data
Approved in 4 jurisdictions
Trial Summary
What is the purpose of this trial?This trial tests a new treatment for advanced throat cancer caused by HPV. It uses chemotherapy first, then a precise robotic surgery to remove the cancer. This method aims to reduce the severe side effects of traditional treatments and improve patients' quality of life. Transoral robotic surgery (TORS) has become an accepted initial treatment for T1 and T2 head and neck squamous cell carcinoma (HNSCC).
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are receiving any other investigational agent, you cannot participate in this study.
What data supports the effectiveness of the treatment for throat cancer?
Research shows that docetaxel, a drug used in the treatment, has been effective in treating head and neck cancers, with response rates of 33% to 44% when combined with other drugs like cisplatin. Additionally, adding docetaxel to other treatments has improved survival rates and quality of life for patients with advanced head and neck cancer.
12345Is the combination of chemotherapy and robotic surgery for throat cancer safe?
Docetaxel, a chemotherapy drug used in various cancers, has been studied for safety in head and neck cancer. It can cause severe neutropenia (a drop in white blood cells), but alternate dosing schedules may reduce this risk. Safety data for robotic surgery specifically in throat cancer is not provided in the available research.
12678What makes the chemotherapy and robotic surgery treatment for throat cancer unique?
This treatment combines docetaxel, a drug known for its effectiveness in head and neck cancers, with robotic surgery, which may offer more precision and less invasive procedures compared to traditional surgery. This combination could potentially enhance treatment outcomes by leveraging the strengths of both chemotherapy and advanced surgical techniques.
13579Eligibility Criteria
This trial is for adults over 18 with HPV-related oropharyngeal cancer (cancer in parts of the throat like tonsils and tongue), who are fit for surgery, have not had previous treatments, and no distant spread of cancer. They must be able to perform daily activities mostly without aid (Karnofsky >60% or ECOG <2) and agree to use contraception.Inclusion Criteria
My throat cancer is p16 positive.
I have not received any treatment for my condition.
My cancer has not spread to distant parts of my body.
I am fit for surgery and my tumor can be completely removed through the mouth.
My blood tests show normal white cell, platelet counts, and kidney function.
I am older than 18 years.
I haven't had any cancer in the last 5 years, except for skin cancer.
I can care for myself and am up more than 50% of my waking hours.
My cancer is at a specific advanced stage (Stage III or early Stage IV).
Exclusion Criteria
My advanced cancer cannot be surgically removed without losing organ function.
I currently have an infection.
I have had head or neck cancer before, but not skin cancer.
My cancer has spread to distant parts of my body.
Doctors cannot reach my tumor through my mouth due to its location.
My tumor is P16 negative.
I have 5 or more cancerous lymph nodes in my neck.
My cancer is at stage IVB according to AJCC-7.
My cancer has spread outside the lymph node.
I have mild or no nerve damage symptoms.
I have previously been treated with Taxanes or Cisplatin.
Participant Groups
The study tests if chemotherapy followed by Transoral Robotic Surgery (TORS) can effectively treat oropharyngeal cancer with fewer side effects than current chemo-radiotherapy methods. The goal is a high cure rate with less than a 10% failure rate, avoiding radiotherapy in most cases.
1Treatment groups
Experimental Treatment
Group I: Neoadjuvant chemotherapy and surgeryExperimental Treatment1 Intervention
Docetaxel and Cisplatin x 3 cycles followed by Transoral robotic surgery and neck dissection.
Carboplatin may be used instead of Cisplatin.
Docetaxel is already approved in United States, European Union, Canada, Japan for the following indications:
🇺🇸 Approved in United States as Taxotere for:
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
🇪🇺 Approved in European Union as Taxotere for:
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
🇨🇦 Approved in Canada as Taxotere for:
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
🇯🇵 Approved in Japan as Taxotere for:
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
McGill University Health CentreMontreal, Canada
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Who is running the clinical trial?
Nader SadeghiLead Sponsor
McGill University Health Centre/Research Institute of the McGill University Health CentreCollaborator
References
Pembrolizumab plus docetaxel for the treatment of recurrent/metastatic head and neck cancer: A prospective phase I/II study. [2023]Taxane-based checkpoint inhibitor combination therapy might improve the outcome in recurrent/metastatic (R/M) head and neck cancer (HNSCC) patients. Thus, we investigated the efficacy and safety of docetaxel (DTX) plus pembrolizumab (P) in a prospective phase I/II trial.
The role of docetaxel in the management of squamous cell cancer of the head and neck. [2018]The activity of docetaxel (Taxotere) as a single agent (overall response rates, 24%-45%) in the treatment of patients with recurrent squamous cell cancer of the head and neck has resulted in the investigation of docetaxel-based doublet and triplet combinations in both the recurrent and neoadjuvant settings. When combined with cisplatin, with or without fluorouracil (5-FU), in the treatment of recurrent disease, response rates of 33% to 44% have been observed for docetaxel, with median survival ranging from 9.6 to 11 months. In the neoadjuvant setting, response rates have been typically greater than 90%, with promising disease-free and overall survival results. Randomized trials are now under way to assess the value of docetaxel-based therapy relative to that of the standard cisplatin/5-FU combination in both the neoadjuvant and recurrent settings. Preclinical data indicate that docetaxel is a potent radiosensitizer and its initial evaluation with concurrent radiation in patients with locally advanced unresectable squamous cell cancer of the head and neck suggests feasibility. Phase II evaluation of this approach is in progress.
Docetaxel and cisplatin: an active regimen in patients with locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck. Results of a phase II study of the EORTC Early Clinical Studies Group. [2020]Docetaxel and cisplatin are among the most active antitumor agents in head and neck cancer, and phase I studies found the combination of the two drugs to be feasible. The EORTC ECSG performed a multicenter phase II study in patients with locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck to evaluate the antitumor efficacy and toxicity of this combination.
Short-term health-related quality of life and symptom control with docetaxel, cisplatin, 5-fluorouracil and cisplatin (TPF), 5-fluorouracil (PF) for induction in unresectable locoregionally advanced head and neck cancer patients (EORTC 24971/TAX 323). [2022]The EORTC 24971/TAX 323, a phase III study of 358 patients with unresectable locoregionally advanced squamous cell carcinoma of the head and neck, showed an improved progression-free and overall survival (OS) with less toxicity when docetaxel (T) was added to cisplatin and 5-fluorouracil (PF) for induction and given before radiotherapy (RT). The impact of the addition of docetaxel on patients' health-related quality of life (HRQOL) and symptoms was investigated.
Docetaxel and cisplatin in locally advanced or metastatic squamous-cell carcinoma of the head and neck: a phase II study of the Southern Italy Cooperative Oncology Group (SICOG). [2020]Docetaxel is one of the most promising new drugs against squamous-cell carcinoma of the head and neck (SCCHN), while cisplatin is one of the most active single agents. A phase I study has shown the feasibility of the combination of the two drugs, and activity in SCCHN has been seen.
Docetaxel: a tubulin-stabilizing agent approved for the management of several solid tumors. [2018]Docetaxel is a semisynthetic taxane that acts by binding to the beta-tubulin subunit of the microtubules, resulting in cell-cycle arrest and apoptosis. It is approved for the management of early and advanced breast cancer, locally advanced and metastatic lung cancer and hormone refractory prostate cancer. Docetaxel has also shown significant antitumor activity in ovarian and gastric tumors and has very recently been approved for the treatment of advanced gastric cancer. Severe neutropenia is the major dose-limiting toxicity with the approved three-weekly regimens, although alternate weekly schedules with less myelotoxicity have been developed for patients with poor bone marrow reserve. This article will review the pharmacology and trials leading to the clinical approval of this agent.
Docetaxel: an active drug for squamous cell carcinoma of the head and neck. [2018]We conducted a phase II study designed to evaluate the activity, safety, and tolerability of docetaxel (Taxotere: Rhône-Poulenc Rorer Pharmaceuticals Inc, Collegeville, PA) in patients with advanced, incurable, or recurrent squamous cell carcinoma of the head and neck (SCCHN) who had not received prior palliative chemotherapy.
Docetaxel (Taxotere): an active drug for the treatment of patients with advanced squamous cell carcinoma of the head and neck. EORTC Early Clinical Trials Group. [2020]Docetaxel (Taxotere) is a new cytotoxic agent acting as a promoter of tubulin polymerisation with broad spectrum antitumor activity in preclinical testing. Phase I clinical trials have shown promising activity of docetaxel in patients with breast, ovarian and lung carcinomas. The objective of this open multicentre phase II study was to determine the efficacy and tolerability of this agent in patients with head and neck cancer.
The growth inhibiting effect of docetaxel (Taxotere) in head and neck squamous cell carcinoma xenografts. [2019]Docetaxel (Taxotere) is a new antitumor agent with activity in patients with ovarian, lung and breast cancer. In this study, docetaxel was tested for its antitumor effect in human tumor xenografts derived from head and neck squamous cell carcinoma (HNSCC). A significant growth inhibiting effect was observed in the two tested lines, at the well tolerated dose of 20 m/kg docetaxel. Two intravenous injections were given with a week interval. Both lines were less sensitive to treatment with cisplatin, indicating that no cross-reactivity exists between these drugs. Docetaxel has a promising outlook in the treatment of patients with head and neck squamous cell carcinoma (HNSCC).