p16+ Oropharyngeal Cancer Radiation Optimization Trial Reducing Elective Treatment Volumes (PROTEcT)
NCT ID: NCT04104945
Last Updated: 2024-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
32 participants
INTERVENTIONAL
2021-01-12
2028-10-21
Brief Summary
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Detailed Description
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Chemotherapy will be administered as per standard of care, consisting of concurrent cisplatin (high-dose: 100mg/m2 IV every 3 weeks or low-dose: 40mg/m2 IV every week) or cetuximab (at the discretion of medical oncologist).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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De-intensified chemoradiotherapy
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.
De-intensified chemoradiotherapy
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.
Interventions
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De-intensified chemoradiotherapy
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Tom Baker Cancer Centre
OTHER
Cross Cancer Institute
OTHER
AHS Cancer Control Alberta
OTHER
Responsible Party
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Principal Investigators
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Harvey Quon, MD
Role: PRINCIPAL_INVESTIGATOR
Tom Baker Cancer Centre
Locations
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Tom Baker Cancer Centre
Calgary, Alberta, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PROTEcT
Identifier Type: -
Identifier Source: org_study_id
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