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New treatment option for Squamous Cell Carcinoma of the Oropharynx
Official title p16+ Oropharyngeal Cancer Radiation Optimization Trial Reducing Elective Treatment Volumes (PROTEcT)
ClinicalTrials.gov ID: NCT04104945
What this study is testing
- What it's testing
- Volume and Dose De-Intensified Radiotherapy for p16+ Squamous Cell Carcinoma of the Oropharynx: A Multi-Centre, Single Arm Prospective Cohort Study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age 18 or older
- Provide informed consent
- ECOG performance status 0-2
- Histologically confirmed squamous cell carcinoma
- p16-positive tumor, as determined by immunohistochemistry at local hospital
You likely can't join if
- \- Clinical, radiologic or pathologic Ib nodal involvement (including invasion into submandibular gland)
- Primary cancer with extension and involvement of the oral cavity
- Metastatic disease
- Contraindications to radiotherapy or chemotherapy
- Prior history of head and neck cancer within 5 years
- Prior head and neck radiation at any time
See the full eligibility criteria
- Age 18 or older
- Provide informed consent
- ECOG performance status 0-2
- Histologically confirmed squamous cell carcinoma
- p16-positive tumor, as determined by immunohistochemistry at local hospital
- Primary tumor site in the oropharynx (includes tonsil, soft palate, base of tongue, walls of oropharynx)
- Eligible for curative intent treatment.
- Smokers and non-smokers are included
- Tumor stage (AJCC 8th edition): T1 to T3
- Nodal stage (AJCC 8th edition): N1 to N2
- Adequate bone marrow function, hepatic, and renal function for chemotherapy (Hemoglobin \> 80 g/L; Absolute neutrophil count \>1.5x109 /L, platelets \> 100 x109/L; Bilirubin \< 35 umol/L; AST or ALT \< 3 x the upper...
- \- Clinical, radiologic or pathologic Ib nodal involvement (including invasion into submandibular gland)
- Primary cancer with extension and involvement of the oral cavity
- Metastatic disease
- Contraindications to radiotherapy or chemotherapy
- Prior history of head and neck cancer within 5 years
- Prior head and neck radiation at any time
- Inability to attend full course of radiotherapy or follow-up visits
- Pregnant or lactating women
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.