Trial Outcomes & Findings for Transoral Robotic Surgery for rECurrent Tumours of the Upper Aerodigestive Tract (NCT NCT04673929)

NCT ID: NCT04673929

Last Updated: 2025-01-09

Results Overview

Disease-free survival measured at 2 years for all recruited participants - data retrieved from medical records retrospectively Measured as 2 years post TORS procedure

• Recruitment status: COMPLETED
• Target enrollment: 278 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2025-01-09

Participant Flow

Participant milestones

Measure	Patients With Head & Neck Cancer (HNC) Recurrence Treated With Transoral Robotic Surgery (TORS) Report of disease-free survival at 2 years for patients with HNC recurrence treated with TORS
Overall Study STARTED	278
Overall Study COMPLETED	162
Overall Study NOT COMPLETED	116

Reasons for withdrawal

Measure	Patients With Head & Neck Cancer (HNC) Recurrence Treated With Transoral Robotic Surgery (TORS) Report of disease-free survival at 2 years for patients with HNC recurrence treated with TORS
Overall Study Death	73
Overall Study Did not reach the 2 year follow up point (observational study)	43

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Patients With HNC Recurrence Treated With TORS n=278 Participants Report of disease-free survival at 2 years for patients with HNC recurrence treated with TORS
Age, Categorical <=18 years	0 Participants n=278 Participants
Age, Categorical Between 18 and 65 years	166 Participants n=278 Participants
Age, Categorical >=65 years	112 Participants n=278 Participants
Age, Continuous	61 years n=278 Participants
Sex: Female, Male Female	56 Participants n=278 Participants
Sex: Female, Male Male	222 Participants n=278 Participants
Region of Enrollment United Kingdom	278 Participants n=278 Participants
Performance Status Scale - Head and Neck Normalcy of diet	77.1 units on a scale n=278 Participants

PRIMARY outcome

Timeframe: 24 months

Disease-free survival measured at 2 years for all recruited participants - data retrieved from medical records retrospectively

Measured as 2 years post TORS procedure

Outcome measures

Measure	Patients With HNC Recurrence Treated With TORS n=235 Participants Report of disease-free survival at 2 years for patients with HNC recurrence treated with TORS
Disease-free Survival at 2 Years	111 Participants

PRIMARY outcome

Timeframe: 24 months

Disease-specific survival measured at 2 years for all recruited participants - data retrieved from medical records retrospectively

Measured as 2 years post TORS procedure

Outcome measures

Measure	Patients With HNC Recurrence Treated With TORS n=278 Participants Report of disease-free survival at 2 years for patients with HNC recurrence treated with TORS
Disease-specific Survival at 2 Years	219 Participants

SECONDARY outcome

Timeframe: 24 months

Overall survival at 2 years - number of living participants at end of 2 year follow up - data retrieved from medical records retrospectively

Measured as 2 years post TORS procedure

Outcome measures

Measure	Patients With HNC Recurrence Treated With TORS n=278 Participants Report of disease-free survival at 2 years for patients with HNC recurrence treated with TORS
Overall Survival at 2 Years	192 Participants

SECONDARY outcome

Timeframe: 12 months

Rate of gastrostomy use at 1 year - number of participants having a gastrostomy post surgery

Outcome measures

Measure	Patients With HNC Recurrence Treated With TORS n=278 Participants Report of disease-free survival at 2 years for patients with HNC recurrence treated with TORS
Rate of Gastrostomy Use at 1 Year	109 Participants

SECONDARY outcome

Timeframe: 12 months

Rate of tracheostomy use at 1 year

Outcome measures

Measure	Patients With HNC Recurrence Treated With TORS n=277 Participants Report of disease-free survival at 2 years for patients with HNC recurrence treated with TORS
Rate of Tracheostomy Use at 1 Year	105 Participants

Adverse Events

Patients With HNC Recurrence Treated With TORS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 115 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Vinidh Paleri

The Royal Marsden Hospital

Phone: 02078082732

Email: vinidh.paleri@rmh.nhs.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place