Clinical trial NCT05065086: Single Modality Trans Oral Robotic Surgery for Primary Oropharyngeal Cancer: Exploring the Impact of Surgical Margins on Local Disease Recurrence
Official title: Single Modality Trans Oral Robotic Surgery for Primary Oropharyngeal Cancer: Exploring the Impact of Surgical Margins on Local Disease Recurrence
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Head and Neck Squamous Cell Carcinoma
Keywords: Primary OPSCC
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Institute of Cancer Research, United Kingdom
First posted: 2021-10-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of Primary OPSCC with Index cancer treated with TORS, without adjuvant therapy, on or before 31st July 2019.

Brief summary: Retrospective observational cohort study investigating Single modality Trans Oral Robotic surgery for primary oropharyngeal cancer: exploring the impact of surgical Margins on local disease recurrence.

Detailed description: The STORM study will examine transoral surgery performed before 31st July 2019. STORM is a retrospective observational cohort study, involving international centres performing TORS for primary OPSCC.

The main aim of this study is to explore the impact of surgical margins on local disease recurrence in primary oropharyngeal squamous cell carci-noma treated with transoral robotic surgery (TORS) without adjuvant therapy.

The primary objective is to report local recurrence-free survival. The primary endpoint will be Local recurrence-free survival time.

The secondary objectives are to report overall survival, disease-specific survival and disease-free survival, and to report post-operative haemor-rhage rates. The secondary endpoints include Overall survival time, Dis-ease-specific survival time, Disease-free survival time, Post-operative haemorrhage time.

Exploratory objective to identify a clinically relevant cut-off for surgical margins as a predictor of local disease recurrence.

Eligibility criteria: Inclusion Criteria:

* 18 years and older.
* Primary OPSCC.
* Index cancer treated with TORS without adjuvant therapy.
* Any post-operative TNM classification.
* TORS performed on or before 31st July 2019.

Exclusion Criteria:

* TORS preformed for diagnostic or palliative intentions.
* Known distant metastasis at time of TORS.
* Nasopharyngeal and thyroid cancers.
* Patients undergoing neoadjuvant or adjuvant chemotherapy, biotherapy, immunotherapy or radiotherapy to either the neck or primary site.

Primary outcomes:
measure: Local recurrence-free survival time
timeFrame: At 2 years
Secondary outcomes:
measure: Overall survival time
timeFrame: At 2 and 5 years
measure: Disease-specific survival time
timeFrame: At 2 and 5 years
measure: Disease-free survival time
timeFrame: At 2 and 5 years
measure: Post-operative haemorrhage time
timeFrame: Within 30 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: The Royal Marsden Hospital
Study officials:
References: