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Clinical Trials in Australia / NCT03210103
Active, not recruiting Not applicable

Primary Radiotherapy Versus Primary Surgery for HPV-Associated Oropharyngeal Cancer

NCT03210103 · tracked via the Priya Life Science Australia tracker
Phase
Not applicable
Started
2018-01-26
Last updated
2026-01-28

Condition(s) studied

Oropharyngeal Cancer

Investigational drug(s) / intervention(s)

RadiationTransoral Surgery (TOS) + Neck Dissection

Radiation: Standard of Care: Radiation +/- Chemotherapy

Transoral Surgery (TOS) + Neck Dissection: Transoral Surgery (TOS) + Neck Dissection (plus radiation, if required)

Study summary

The goal of this randomized treatment de-escalation study is to formally compare outcomes in HPV related oropharyngeal cancer tumors treated with a primary radiotherapy versus a primary surgical approach, to provide a high level of evidence to guide the selection of treatment options for a subsequent phase III trial

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age 18 years or older * willing to provide informed consent * ECOG performance status 0-2 * Histologically confirmed squamous cell carcinoma * P16 positive, or HPV positive * Primary tumor site in the oropharynx (includes tonsil, soft palate, base of tongue, walls of oropharynx) * Eligible for curative intent treatment, with likely negative resection margins at surgery. For patients where adequate transoral access is in question, they will first undergo an examination under anesthesia prior to randomization to ensure adequate exposure can be obtained. * Smokers and non-smokers are included. Patients will be stratified by ,\<10 pack years smoking history versus \> or equal to 10 pack years. * Tumor stage (AJCC 8th edition): T1 or T2 * Nodal stage (AJCC 8th edition): N0, N1, or N2 * For patients who may require chemotherapy (ie, patients with multiple lymph nodes positive or a single node more than 3 cm in size, in any plane, CBC/differential within 4 weeks prior to randomization with adequate bone marrow function, hepatic, and renal function defined as: Hemoglobin ≥ 80 g/L; Absolute neutrophil count ≥ 1.5 x 10 9/L, platelets ≥ 100 x 10 9/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 * patients assessed at head and neck multidisciplinary clinic (with assessment by radiation oncologist and surgeon) and presented at multidisciplinary tumor board prior to randomization Exclusion Criteria: * unambiguous clinical or radiological evidence of extranodaal extension on pre-treatment imaging. This includes the presence of matted notes, defined as 3 or more nodes that are abutting with loss of intervening fat planes * Serious medical comorbidities or other contraindications to radiotherapy, chemotherapy or surgery * prior history of head and neck cancer within 5 years * prior head and neck radiation at any time * metastatic disease * inability to attend full course of radiotherapy or follow up visits * prior invasive malignant disease unless disease-free for at least 5 years or more, with the exception of non-melanoma skin cancer * pregnant or lactating women

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
Gold Coast University Hospital Gold Coast Queensland
Royal Adelaide Hospital Adelaide Australia
Tom Baker Cancer Centre Calgary Alberta
BC Cancer Vancouver British Columbia
London Regional Cancer Program London Ontario
Ottawa Hospital Research Institute Ottawa Ontario
Sunnybrook Research Institute Toronto Ontario
University Health Network Toronto Ontario
Jewish General Hospital Montreal Quebec

More London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's trials in Australia

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03210103 on ClinicalTrials.gov ↗ ← All trials in Australia