Single and Combined Modality Trans-Oral Robotic Surgery in Early Oropharyngeal Cancer
ConditionCancer Head Neck
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRoyal Marsden NHS Foundation Trust
About this trial
Multi-centre retrospective observational cohort study with optional exploratory radiomic study (international) and prospective molecular analysis studies (UK only).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years and older.
Primary tumour within the oropharynx (defined as tonsil, soft palate, tongue base, lateral and posterior oropharyngeal walls)
Histologically confirmed squamous cell carcinoma.
P16 positive or negative tumours
Disqualifiers
Moderate to advanced stage T3-T4 oropharyngeal SCC
TORS performed for diagnostic, recurrent, or palliative intentions.
Prior history of head and neck cancer or radiation therapy at any time
Known distant metastatic disease.
Trial population
Patients aged 18 years and older diagnosed with early (T1-T2) primary oropharyngeal squamous cell carcinoma, treated with transoral robotic surgery with or without adjuvant therapy.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Molecular Analysis
GeneticGermline and circulating tumour DNA analysis of buccal/ blood samples and molecular analysis of primary and recurrent tumour tissue samples
Radiomic/ Morphological analysis
Other interventionRadiomic analysis and assessment of morphological features of pre-operative CT/ MRI imaging in patients who have undergone TORS for primary oropharyngeal cancer.
Treatment groups
250 Participants
are divided into 3 treatment groupsGroup A: Retrospective observational cohort0 interventions
Group B: Exploratory molecular analysis1 intervention
Group C: Radiology/ radiomic analysis1 intervention
Trial outcomes
Primary outcomes
1
To report 2-year locoregional survival outcomes following TORS for primary OPSCC with or without adjuvant therapy
To report 2-year locoregional survival outcomes following TORS for primary OPSCC with or without adjuvant therapy
Time frame
2 yearsSecondary outcomes
1
To report 2-year overall survival outcomes following TORS for primary OPSCC with or without adjuvant therapy.
To report 2-year overall survival outcomes following TORS for primary OPSCC with or without adjuvant therapy.
Time frame
2 years2
To report 2-year disease-free survival outcomes following TORS for primary OPSCC with or without adjuvant therapy.
To report 2-year disease-free survival outcomes following TORS for primary OPSCC with or without adjuvant therapy.
Time frame
2 years3
To report 2-year disease specific survival outcomes following TORS for primary OPSCC with or without adjuvant therapy.
To report 2-year disease specific survival outcomes following TORS for primary OPSCC with or without adjuvant therapy.
Time frame
2 years4
Define the optimum margin cut off required to avoid 2-year locoregional recurrence in primary TORS without adjuvant therapy
Define the optimum margin cut off required to avoid 2-year locoregional recurrence in primary TORS without adjuvant therapy
Time frame
2 yearsOther outcomes
1
Ascertain the differing molecular characteristics between tumours that experience early 2-year local recurrence and those who do not.
Ascertain the differing molecular characteristics between tumours that experience early 2-year local recurrence and those who do not.
Time frame
2 years2
Ascertain the changes in circulating tumour DNA levels in patients undergoing primary TORS for early oropharyngeal cancer.
Ascertain the changes in circulating tumour DNA levels in patients undergoing primary TORS for early oropharyngeal cancer.
Time frame
2 years3
Correlation of high-risk genetic features with 2 year local recurrence outcomes
Correlation of high-risk genetic features with 2 year local recurrence outcomes
Time frame
2 years4
Ascertain CT or MRI radiomic/ or morphological characteristics of tumours that develop 2-year local recurrence.
Ascertain CT or MRI radiomic/ or morphological characteristics of tumours that develop 2-year local recurrence.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov