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

RECRUITINGN/ASponsored by AHS Cancer Control Alberta
Actively Recruiting
PhaseN/A
SponsorAHS Cancer Control Alberta
Started2021-01-12
Est. completion2028-10-21
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT04104945

Summary

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

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion 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 limit of normal; serum creatinine \< 130 umol/L or creatinine clearance ≥ 50 ml/min)

Exclusion Criteria:

* \- 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

Conditions2

CancerSquamous Cell Carcinoma of the Oropharynx

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