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Radiation
De-intensified chemoradiotherapy for Squamous Cell Carcinoma (PROTEcT Trial)
N/A
Recruiting
Led By Harvey Quon, MD
Research Sponsored by AHS Cancer Control Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 5 years
Awards & highlights
PROTEcT Trial Summary
This trial found that a lower volume, lower dose of radiation was just as effective as the standard of care for p16+ oropharyngeal squamous cell carcinoma.
Who is the study for?
Adults with p16+ squamous cell carcinoma of the oropharynx, eligible for curative treatment, can join this trial. They must have certain tumor and nodal stages (T1-T3, N1-N2), good organ function, and an ECOG performance status of 0-2. Smokers and non-smokers are welcome. Those with metastatic disease, prior head and neck cancer/radiation, or who are pregnant cannot participate.Check my eligibility
What is being tested?
The PROTEcT study is testing a de-intensified chemoradiotherapy approach for patients with p16+ oropharyngeal cancer. It's a single-arm prospective cohort study across multiple centers aiming to see if reducing radiation volume and dose is effective.See study design
What are the potential side effects?
While specific side effects aren't listed here, de-intensified chemoradiotherapy may generally lead to reduced appetite, mouth sores, dry mouth/throat issues due to radiation; chemotherapy could cause nausea/vomiting, fatigue, hair loss.
PROTEcT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Toxicity Criteria for Adverse Events
Xerostomia
Other outcome measures
#1 Quality of life
#2 Quality of life
#3 Quality of life
+4 morePROTEcT Trial Design
1Treatment groups
Experimental Treatment
Group I: De-intensified chemoradiotherapyExperimental Treatment1 Intervention
Radiotherapy to a dose of 60 Gy to the primary tumour and involved lymph nodes and 54 Gy to subclinical regions at risk in 30 fractions. Reduced volume of elective nodal radiation.
Find a Location
Who is running the clinical trial?
AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
36,180 Total Patients Enrolled
Tom Baker Cancer CentreOTHER
29 Previous Clinical Trials
8,823 Total Patients Enrolled
Cross Cancer InstituteOTHER
61 Previous Clinical Trials
19,158 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My cancer has spread to nearby lymph nodes or into the submandibular gland.I have had head or neck cancer in the past 5 years.My cancer has spread to other parts of my body.I have had radiation therapy on my head or neck before.I cannot attend all radiotherapy sessions or follow-up visits.I am able to care for myself and perform daily activities.My cancer is confirmed to be squamous cell carcinoma.My cancer has spread to nearby lymph nodes but not to distant parts of my body.My cancer originates in the oropharynx area.My tumor is p16 positive.My blood, liver, and kidney functions meet the required levels for chemotherapy.My cancer is in an early to moderately advanced stage.I cannot undergo radiotherapy or chemotherapy due to health reasons.My treatment is aimed at curing my condition.My primary cancer has spread to my mouth.
Research Study Groups:
This trial has the following groups:- Group 1: De-intensified chemoradiotherapy
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.
How many study subjects are you following at this time?
"That is correct. The study, which began recruiting on 1/12/2021, is still looking for participants. The most recent update was on 7/18/2022. Currently, there are 2 locations where 32 people are needed."
Answered by AI
Are investigators still enrolling new participants in this research project?
"That is correct. The clinical trial is still actively looking for participants, according to the information on clinicaltrials.gov. This study was originally posted on 1/12/2021, and the most recent edit was on 7/18/2022. They are hoping to find 32 participants total, from 2 different sites."
Answered by AI
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