Primary Radiotherapy Versus Primary Surgery for HPV-Associated Oropharyngeal Cancer
NCT ID: NCT03210103
Last Updated: 2026-01-28
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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ACTIVE_NOT_RECRUITING
NA
61 participants
INTERVENTIONAL
2018-01-26
2028-08-15
Brief Summary
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Detailed Description
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The study will compare overall survival rates relative to historical controls for de-intensified primary radiotherapy \[60 GY +/- chemotherapy\] versus transoral surgery (TOS) and neck dissection \[+/- adjuvant 50Gy radiotherapy\] in patients with early T-stage HPV-positive squamous cell carcinoma of the oropharynx and to compare quality of life (QOL) profiles.
The study will require a sample size of 140 patients randomized in a 1:1 ratio between the two arms. Arm 1 (radiotherapy +/1 chemotherapy) and Arm 2 (TOS)
Patients will be followed for a total of 5 years
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1, Radiation +/- Chemotherapy
Standard Treatment (Radiation +/- Chemotherapy)
Radiation
Standard of Care: Radiation +/- Chemotherapy
Arm 2, TOS + Neck Dissection
Transoral Surgery (TOS) + Neck Dissection (plus radiation, if required)
Transoral Surgery (TOS) + Neck Dissection
Transoral Surgery (TOS) + Neck Dissection (plus radiation, if required)
Interventions
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Radiation
Standard of Care: Radiation +/- Chemotherapy
Transoral Surgery (TOS) + Neck Dissection
Transoral Surgery (TOS) + Neck Dissection (plus radiation, if required)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
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Principal Investigators
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David Palma
Role: PRINCIPAL_INVESTIGATOR
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Locations
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Gold Coast University Hospital
Gold Coast, Queensland, Australia
Royal Adelaide Hospital
Adelaide, , Australia
Tom Baker Cancer Centre
Calgary, Alberta, Canada
BC Cancer
Vancouver, British Columbia, Canada
London Regional Cancer Program
London, Ontario, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Sunnybrook Research Institute
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Countries
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References
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Palma DA, Prisman E, Berthelet E, Tran E, Hamilton S, Wu J, Eskander A, Higgins K, Karam I, Poon I, Husain Z, Enepekides D, Hier M, Richardson K, Mlynarek A, Johnson-Obaseki S, Gaudet M, Bayley A, Dowthwaite S, Jackson JE, Dzienis M, O'Neil J, Chandarana S, Banerjee R, Hart R, Chung J, Tenenholtz T, Le H, Yoo J, Mendez A, Winquist E, Kuruvilla S, Stewart P, Warner A, Mitchell S, Chen J, Parker C, Kwan K, Theurer J, Bahig H, Christopoulos A, Mendez LC, Sathya J, Hammond JA, Read N, Venkatesan V, Fung K, Nichols AC. Radiation vs. trans-oral surgery for treatment de-escalation in HPV-related oropharyngeal cancers: Primary analysis of the ORATOR2 randomized trial. Eur J Cancer. 2025 May 2;220:115343. doi: 10.1016/j.ejca.2025.115343. Epub 2025 Mar 10.
Palma DA, Prisman E, Berthelet E, Tran E, Hamilton S, Wu J, Eskander A, Higgins K, Karam I, Poon I, Husain Z, Enepekides D, Hier M, Sultanem K, Richardson K, Mlynarek A, Johnson-Obaseki S, Odell M, Bayley A, Dowthwaite S, Jackson JE, Dzienis M, O'Neil J, Chandarana S, Banerjee R, Hart R, Chung J, Tenenholtz T, Krishnan S, Le H, Yoo J, Mendez A, Winquist E, Kuruvilla S, Stewart P, Warner A, Mitchell S, Chen J, Parker C, Wehrli B, Kwan K, Theurer J, Sathya J, Hammond JA, Read N, Venkatesan V, MacNeil SD, Fung K, Nichols AC. Assessment of Toxic Effects and Survival in Treatment Deescalation With Radiotherapy vs Transoral Surgery for HPV-Associated Oropharyngeal Squamous Cell Carcinoma: The ORATOR2 Phase 2 Randomized Clinical Trial. JAMA Oncol. 2022 Jun 1;8(6):1-7. doi: 10.1001/jamaoncol.2022.0615.
Nichols AC, Lang P, Prisman E, Berthelet E, Tran E, Hamilton S, Wu J, Fung K, de Almeida JR, Bayley A, Goldstein DP, Eskander A, Husain Z, Bahig H, Christopoulous A, Hier M, Sultanem K, Richardson K, Mlynarek A, Krishnan S, Le H, Yoo J, MacNeil SD, Mendez A, Winquist E, Read N, Venkatesan V, Kuruvilla S, Warner A, Mitchell S, Corsten M, Rajaraman M, Johnson-Obaseki S, Eapen L, Odell M, Chandarana S, Banerjee R, Dort J, Matthews TW, Hart R, Kerr P, Dowthwaite S, Gupta M, Zhang H, Wright J, Parker C, Wehrli B, Kwan K, Theurer J, Palma DA. Treatment de-escalation for HPV-associated oropharyngeal squamous cell carcinoma with radiotherapy vs. trans-oral surgery (ORATOR2): study protocol for a randomized phase II trial. BMC Cancer. 2020 Feb 14;20(1):125. doi: 10.1186/s12885-020-6607-z.
Other Identifiers
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ORATOR2
Identifier Type: -
Identifier Source: org_study_id
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