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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03210103




Registration number
NCT03210103
Ethics application status
Date submitted
28/06/2017
Date registered
6/07/2017

Titles & IDs
Public title
Primary Radiotherapy Versus Primary Surgery for HPV-Associated Oropharyngeal Cancer
Scientific title
A Randomized Trial of Treatment De-Escalation for HPV-Associated Oropharyngeal Squamous Cell Carcinoma: Radiotherapy vs. Trans-Oral Surgery (ORATOR II)
Secondary ID [1] 0 0
ORATOR2
Universal Trial Number (UTN)
Trial acronym
ORATOR2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oropharyngeal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Radiation
Treatment: Surgery - Transoral Surgery (TOS) + Neck Dissection

Active comparator: Arm 1, Radiation +/- Chemotherapy - Standard Treatment (Radiation +/- Chemotherapy)

Experimental: Arm 2, TOS + Neck Dissection - Transoral Surgery (TOS) + Neck Dissection (plus radiation, if required)


Treatment: Other: Radiation
Standard of Care: Radiation +/- Chemotherapy

Treatment: Surgery: Transoral Surgery (TOS) + Neck Dissection
Transoral Surgery (TOS) + Neck Dissection (plus radiation, if required)
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
Quality of Life 1 year post treatment
Timepoint [1] 0 0
1 year post treatment
Secondary outcome [2] 0 0
Progression free survival comparison with historical controls
Timepoint [2] 0 0
5 years
Secondary outcome [3] 0 0
Quality of life
Timepoint [3] 0 0
Baseline to 5 years follow up
Secondary outcome [4] 0 0
Quality of life
Timepoint [4] 0 0
Baseline to 5 years follow up
Secondary outcome [5] 0 0
Quality of life
Timepoint [5] 0 0
Baseline to 5 years follow up
Secondary outcome [6] 0 0
Quality of life
Timepoint [6] 0 0
Baseline to 5 years follow up
Secondary outcome [7] 0 0
Quality of life
Timepoint [7] 0 0
Baseline to 5 years follow up
Secondary outcome [8] 0 0
Quality of life
Timepoint [8] 0 0
Baseline to 5 years follow up
Secondary outcome [9] 0 0
toxicity profile of both study arms using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 4
Timepoint [9] 0 0
Randomization until 5 years follow up
Secondary outcome [10] 0 0
Feeding tube rate at 1 year
Timepoint [10] 0 0
baseline to 1 year post treatment
Secondary outcome [11] 0 0
CTCAE Dysphagia grade
Timepoint [11] 0 0
baseline to 5 years post treatment
Secondary outcome [12] 0 0
Speech intelligibility
Timepoint [12] 0 0
baseline to 5 years post treatment
Secondary outcome [13] 0 0
Normalcy of diet
Timepoint [13] 0 0
baseline to 5 years post treatment
Secondary outcome [14] 0 0
2 year progression-free survival comparison between Arm 1 and Arm 2
Timepoint [14] 0 0
2 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/01/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/08/2028
Actual
Sample size
Target
Accrual to date
Final
61
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Gold Coast University Hospital - Gold Coast
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
- Gold Coast
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Canada
State/province [4] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Other
Name
Lawson Health Research Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Palma
Address 0 0
Lawson Health Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03210103