Trial record 1 of 1 for:
NCT03210103
Primary Radiotherapy Versus Primary Surgery for HPV-Associated Oropharyngeal Cancer (ORATOR2)
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| ClinicalTrials.gov Identifier: NCT03210103 |
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Recruitment Status :
Active, not recruiting
First Posted : July 6, 2017
Last Update Posted : August 30, 2022
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Sponsor:
Lawson Health Research Institute
Information provided by (Responsible Party):
Lawson Health Research Institute
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Brief 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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Oropharyngeal Cancer | Radiation: Radiation Procedure: Transoral Surgery (TOS) + Neck Dissection | Not Applicable |
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
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
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 61 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | 2 Arm study randomized in a 1:1 ratio |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized Trial of Treatment De-Escalation for HPV-Associated Oropharyngeal Squamous Cell Carcinoma: Radiotherapy vs. Trans-Oral Surgery (ORATOR II) |
| Actual Study Start Date : | January 26, 2018 |
| Estimated Primary Completion Date : | August 15, 2028 |
| Estimated Study Completion Date : | August 15, 2028 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Arm 1, Radiation +/- Chemotherapy
Standard Treatment (Radiation +/- Chemotherapy)
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Radiation: Radiation
Standard of Care: Radiation +/- Chemotherapy
Other Name: Chemotherapy, if required |
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Experimental: Arm 2, TOS + Neck Dissection
Transoral Surgery (TOS) + Neck Dissection (plus radiation, if required)
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Procedure: Transoral Surgery (TOS) + Neck Dissection
Transoral Surgery (TOS) + Neck Dissection (plus radiation, if required)
Other Name: Radiation, if required |
Primary Outcome Measures :
- Overall Survival [ Time Frame: 2 years ]Time from randomization to death from any cause
Secondary Outcome Measures :
- Quality of Life 1 year post treatment [ Time Frame: 1 year post treatment ]Quality of life 1 year post treatment as assessed with the MD Anderson Dysphagia Inventory (MDADI)
- Progression free survival comparison with historical controls [ Time Frame: 5 years ]Defined as time from randomization to death from any cause
- Quality of life [ Time Frame: Baseline to 5 years follow up ]Quality of Life using the following questionnaire: MD Anderson Dysphagia Inventory (MDADI)
- Quality of life [ Time Frame: Baseline to 5 years follow up ]Quality of Life using the following questionnaire: EORTC QLQ C30
- Quality of life [ Time Frame: Baseline to 5 years follow up ]Quality of Life using the following questionnaire: H&N35 scale
- Quality of life [ Time Frame: Baseline to 5 years follow up ]Quality of Life using the following questionnaire: Voice Handicap Index (VHI-10)
- Quality of life [ Time Frame: Baseline to 5 years follow up ]Quality of Life using the following questionnaire: Neck Dissection Impairment Index (NDII)
- Quality of life [ Time Frame: Baseline to 5 years follow up ]Quality of Life using the following questionnaire: Patient Neurotoxicity Questionnaire (PNQ)
- toxicity profile of both study arms using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 4 [ Time Frame: Randomization until 5 years follow up ]To determine to toxicity profile of both study arms using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 4
- Feeding tube rate at 1 year [ Time Frame: baseline to 1 year post treatment ]Measure other functional measurements such as feeding tube rate at 1 year
- CTCAE Dysphagia grade [ Time Frame: baseline to 5 years post treatment ]Measure other functional measurements such as CTCAE Dysphagia grade
- Speech intelligibility [ Time Frame: baseline to 5 years post treatment ]Measure other functional measurements such as speech intelligibility
- Normalcy of diet [ Time Frame: baseline to 5 years post treatment ]Measure other functional measurements such as normalcy of diet
- 2 year progression-free survival comparison between Arm 1 and Arm 2 [ Time Frame: 2 years ]Time from randomization to disease progress at any site or death from any cause
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210103
Locations
| Australia, Queensland | |
| Gold Coast University Hospital | |
| Gold Coast, Queensland, Australia | |
| Australia | |
| Royal Adelaide Hospital | |
| Adelaide, Australia | |
| Canada, Alberta | |
| Tom Baker Cancer Centre | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Canada, British Columbia | |
| BC Cancer | |
| Vancouver, British Columbia, Canada, V5Z 1G1 | |
| Canada, Ontario | |
| London Regional Cancer Program | |
| London, Ontario, Canada, N6A 4L6 | |
| Ottawa Hospital Research Institute | |
| Ottawa, Ontario, Canada, K1Y 4E9 | |
| Sunnybrook Research Institute | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| University Health Network | |
| Toronto, Ontario, Canada, M5G 2C4 | |
| Canada, Quebec | |
| Jewish General Hospital | |
| Montréal, Quebec, Canada, H3T 1E2 | |
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
| Principal Investigator: | David Palma | Lawson Health Research Institute |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Lawson Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT03210103 |
| Other Study ID Numbers: |
ORATOR2 |
| First Posted: | July 6, 2017 Key Record Dates |
| Last Update Posted: | August 30, 2022 |
| Last Verified: | August 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Lawson Health Research Institute:
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Transoral Surgery Head and Neck Cancer |
Additional relevant MeSH terms:
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Oropharyngeal Neoplasms Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site |
Neoplasms Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases |