Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04104945

p16+ Oropharyngeal Cancer Radiation Optimization Trial Reducing Elective Treatment Volumes (PROTEcT)

Led by AHS Cancer Control Alberta · Updated on 2024-03-04

32

Participants Needed

1

Research Sites

405 weeks

Total Duration

On this page

Sponsors

A

AHS Cancer Control Alberta

Lead Sponsor

T

Tom Baker Cancer Centre

Collaborating Sponsor

AI-Summary

What this Trial Is About

Volume and Dose De-Intensified Radiotherapy for p16+ Squamous Cell Carcinoma of the Oropharynx: A Multi-Centre, Single Arm Prospective Cohort Study

CONDITIONS

Official Title

p16+ Oropharyngeal Cancer Radiation Optimization Trial Reducing Elective Treatment Volumes (PROTEcT)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 or older
  • Provide informed consent
  • ECOG performance status 0-2
  • Histologically confirmed squamous cell carcinoma
  • p16-positive tumor confirmed by immunohistochemistry
  • Primary tumor located in oropharynx (tonsil, soft palate, base of tongue, walls of oropharynx)
  • Eligible for curative intent treatment
  • Tumor stage T1 to T3 (AJCC 8th edition)
  • Nodal stage N1 to N2 (AJCC 8th edition)
  • Adequate bone marrow, liver, and kidney function for chemotherapy (Hemoglobin > 80 g/L; Absolute neutrophil count >1.5x10^9/L; Platelets > 100x10^9/L; Bilirubin < 35 umol/L; AST or ALT < 3x upper limit of normal; Serum creatinine < 130 umol/L or creatinine clearance ≥ 50 ml/min)
Not Eligible

You will not qualify if you...

  • Clinical, radiologic, or pathologic involvement of level IB lymph nodes (including submandibular gland invasion)
  • Primary cancer extending into the oral cavity
  • Metastatic disease
  • Contraindications to radiotherapy or chemotherapy
  • Prior head and neck cancer within 5 years
  • Previous head and neck radiation treatment at any time
  • Inability to attend full course of radiotherapy or follow-up visits
  • Pregnant or lactating women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Actively Recruiting

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Research Team

H

Harvey Quon, MD

CONTACT

K

Kelsey Meyer

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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