A Phase 2 interventional study of Radiation and Trans-Oral Surgery (TOS) + Neck Dissection in Head and Neck Cancer and Oropharyngeal Squamous Cell Carcinoma, sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-04.
Sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's · Phase 2, Interventional, and Treatment
The goal of this randomized phase II study is a formal comparison of radiotherapy versus trans-oral surgery as the primary treatment of HPV-negative patients with early-stage oropharyngeal carcinoma.
This study is designed as a randomized phase II study. Patients will be randomized between current standard of care treatment (Arm 1) vs. TOS (Arm 2) in a 1:1 ratio. Additionally, patients will be stratified according to T stage (T1 vs. T2); N stage (N0/1 vs. N2/3)
The randomized phase II design is required for three reasons:
2,018 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
This study's planned enrollment of 68 is above the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's is the lead sponsor of 351 studies on the registry; 2 are open to participants now.
Compared within Squamous Cell Carcinoma of Head and Neck, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Head and Neck Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard Treatment (Radiation +/- Chemotherapy)
Radiation: Radiation
Trans-oral Surgery (TOS) + Neck Dissection (plus radiation is required)
Procedure: Trans-Oral Surgery (TOS) + Neck Dissection
Standard of Care: Radiation +/- Chemotherapy
Also known as: Chemotherapy, if required
Trans-Oral Surgery (TOS) + Neck Dissection (plus radiation, if required)
Also known as: Radiation, if required
Disease-Specific Survival
Time from randomization to death from cancer
Time frame: 5 years
Overall Survival
Time from randomization to death from any cause
Time frame: 5 years
Progression-Free Survival
Defined as time from randomization to death from any cause
Time frame: 5 years
Local-Regional Failure
Defined as time from randomization to first local-regional failure (analyzed as cumulative incidence function with death as competing event)
Time frame: 5 years
Distant Failure
Defined as time from randomization to first distant failure or metastasis (analyzed as cumulative incidence function with death as competing event)
Time frame: 5 years
Any Failure
Defined as time from randomization to first local-regional failure or distant failure, whichever occurs first (analyzed as cumulative incidence function with death as competing event)
Time frame: 5 years
Quality of Life
Quality of Life using the following questionnaire: MD Anderson Dysphagia Inventory (MDADI)
Time frame: Baseline to 5 years follow up
Quality of Life
Quality of Life using the following questionnaire: EORTC QLQ-C30
Time frame: Baseline to 5 years follow up
Quality of Life
Quality of Life using the following questionnaire: H\&N35 scale
Time frame: Baseline to 5 years follow up
Quality of Life
Quality of Life using the following questionnaire: Voice Handicap Index (VHI-10)
Time frame: Baseline to 5 years follow up
Quality of Life
Quality of Life using the following questionnaire: Neck Dissection Impairment Index (NDII)
Time frame: Baseline to 5 years follow up
Quality of Life
Quality of Life using the following questionnaire: Patient Neurotoxicity Questionnaire (PNQ)
Time frame: Baseline to 5 years follow up
Toxicity profile of both study arms using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 4
To determine toxicity profile of both study arms using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 4
Time frame: Randomization until 5 years follow up
Feeding tube rate at 1 year
Measure other functional measurements such as feeding tube rate at 1 year
Time frame: Baseline to 1 year post treatment
CTCAE Dysphagia Grade
Measure other functional measurements such as CTCAE Dysphagia grade
Time frame: Baseline to 5 years post treatment
Started Jun 2020 (actual). Primary completion is estimated for Feb 2028, 92 months after the start.
Of 298 non-industry phase 2 interventional studies under Squamous Cell Carcinoma of Head and Neck, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 85. This study's planned 92 months is above that.
Counting every sponsor, half of 366 studies reached it within 53 months; a quarter within 35 and three quarters within 82.
How these figures are worked out, and which studies are left out of them.
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