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Anti-mitotic Agent
Chemotherapy + Robotic Surgery for Throat Cancer (NECTORS Trial)
Phase 2
Recruiting
Research Sponsored by Nader Sadeghi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Squamous cell cancer of oropharynx, p 16 positive
Treatment Naive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
NECTORS Trial Summary
This trial is studying whether chemotherapy followed by surgery is more effective than the current standard of care for oropharyngeal cancer, which is chemo-radiotherapy.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include those related to Docetaxel chemotherapy such as fatigue, nausea, hair loss, low blood cell counts leading to increased infection risk, mouth sores, and neuropathy (nerve problems). Surgical risks involve bleeding, infection and complications from anesthesia.
NECTORS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My throat cancer is p16 positive.
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I have not received any treatment for my condition.
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My cancer has not spread to distant parts of my body.
Select...
I am fit for surgery and my tumor can be completely removed through the mouth.
Select...
My blood tests show normal white cell, platelet counts, and kidney function.
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I am older than 18 years.
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I haven't had any cancer in the last 5 years, except for skin cancer.
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I can care for myself and am up more than 50% of my waking hours.
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My cancer is at a specific advanced stage (Stage III or early Stage IV).
NECTORS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
: progression free survival.
Secondary outcome measures
Disease Specific Survival (DSS)
General Quality of Life (QOL)
Head and Neck Specific Quality of Life (QOL)
+1 moreSide effects data
From 2014 Phase 4 trial • 32 Patients • NCT0130172959%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab
NECTORS Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
1995
Completed Phase 4
~5620
Find a Location
Who is running the clinical trial?
Nader SadeghiLead Sponsor
McGill University Health Centre/Research Institute of the McGill University Health CentreOTHER
442 Previous Clinical Trials
159,114 Total Patients Enrolled
Nader Sadeghi, MDStudy ChairMcGill University Health Centre/Research Institute of the McGill University Health Centre
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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 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.My cancer has spread to distant parts of my body.I do not have any severe illnesses that could affect my treatment, and I can make informed decisions about my care.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 have not had cancer, except for specific skin cancers or early-stage cervical cancer, in the last 5 years.Doctors cannot reach my tumor through my mouth due to its location.I am older than 18 years.My tumor is P16 negative.I have 5 or more cancerous lymph nodes in my neck.I haven't had any cancer in the last 5 years, except for skin cancer.My cancer is at stage IVB according to AJCC-7.My cancer has spread outside the lymph node.I can care for myself and am up more than 50% of my waking hours.I have mild or no nerve damage symptoms.My cancer is at a specific advanced stage (Stage III or early Stage IV).I have previously been treated with Taxanes or Cisplatin.
Research Study Groups:
This trial has the following groups:- Group 1: Neoadjuvant chemotherapy and surgery
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I eligible to take part in this scientific experiment?
"Prospective participants in this trial must have a confirmed case of tonsillar cancer and fall between the ages 18-80. 60 patients are sought for recruitment."
Answered by AI
Are there openings for participants in this investigation currently?
"Hosted on clinicaltrials.gov, this study is actively searching for participants; the trial was first posted in August of 2018 and updated just recently in April 2022."
Answered by AI
What other investigations have been conducted with Docetaxel?
"Currently, 932 medical studies are investigating the efficacy of Docetaxel with 366 in Phase 3. Although most trials for this drug are based in Shanghai, there are over 61 thousand trial sites worldwide that offer it to patients."
Answered by AI
Is the age range for this clinical examination limited to those over fifty?
"Participants must be between 18 and 80 in order to meet the qualifications of this clinical trial. According to research, there are 141 studies for minors under 18 years old and 3370 trials geared toward seniors over 65."
Answered by AI
Has Docetaxel been authorized by the FDA for medical use?
"Docetaxel received a ranking of 2, as the Phase 2 trial has provided limited evidence for its safety but no data on efficacy."
Answered by AI
How extensive is the participant pool of this clinical experiment?
"Affirmative. Clinicaltrials.gov's data affirms that this trial, which was initially listed on August 14th 2018, is actively seeking participants. Sixty individuals must be enrolled at a single location."
Answered by AI
What maladies has Docetaxel been administered for historically?
"Docetaxel is routinely utilized to address end-of-life decisions, but also has the potential of treating brca1 gene, metastasis of neoplasms, and metastatic bladder cancer."
Answered by AI
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