Trial Outcomes & Findings for The Sinai Robotic Surgery Trial in HPV Positive Oropharyngeal Squamous Cell Carcinoma (SCCA) (SIRS TRIAL) (NCT NCT02072148)

NCT ID: NCT02072148

Last Updated: 2024-05-06

Results Overview

Number of participants with HPV related oropharynx cancer treated with a de-intensified adjuvant protocol with status of disease specific survival. DSS was calculated by measuring the time from trial entry to cancer-related death.

Recruitment status

COMPLETED

Study phase

Target enrollment

112 participants

Primary outcome timeframe

5 years

Results posted on

2024-05-06

Participant Flow

112 participants enrolled prior to transoral surgery. 63 were evaluable and assigned to arm based on risk.

Participant milestones

Participant milestones
Measure	Low Risk Group I Group I: * Complete resection (margins: tonsil \>1mm, tongue \>3mm, pT1-2, pN0-2B), * No LVI, no PNI, \<3 positive nodes. * No ECS, No matted or Level \>III, Observation	Intermediate Risk Group II Group II * Complete resection (margins: tonsil \<1mm, tongue \<1mm, pT1-2, pN0-2B), * +LVI, +PNI, \<3 positive nodes. ≤1mm ECS. Radiotherapy: Postoperative XRT 50 Gy	High Risk Group III IIIA * 3+ nodes, no ECS \> 1mm * Contralateral or supraclavicular nodes IIIB: * Incomplete surgical resection with + surgical margins * ≥ 1 mm ECS * Matted nodes Concurrent Chemoradiation: CCRT with cisplatin 40mg/m2/week IV over approximately 30 minutes, mixed in 250ml normal saline Weekly on Monday or Tuesday any time, or Wednesday prior to radiation Postoperative XRT 56 Gy
Overall Study STARTED	54	29	29
Overall Study COMPLETED	31	16	16
Overall Study NOT COMPLETED	23	13	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Low Risk Group I Group I: * Complete resection (margins: tonsil \>1mm, tongue \>3mm, pT1-2, pN0-2B), * No LVI, no PNI, \<3 positive nodes. * No ECS, No matted or Level \>III, Observation	Intermediate Risk Group II Group II * Complete resection (margins: tonsil \<1mm, tongue \<1mm, pT1-2, pN0-2B), * +LVI, +PNI, \<3 positive nodes. ≤1mm ECS. Radiotherapy: Postoperative XRT 50 Gy	High Risk Group III IIIA * 3+ nodes, no ECS \> 1mm * Contralateral or supraclavicular nodes IIIB: * Incomplete surgical resection with + surgical margins * ≥ 1 mm ECS * Matted nodes Concurrent Chemoradiation: CCRT with cisplatin 40mg/m2/week IV over approximately 30 minutes, mixed in 250ml normal saline Weekly on Monday or Tuesday any time, or Wednesday prior to radiation Postoperative XRT 56 Gy
Overall Study withdrew prior to surgery	23	0	0
Overall Study Death	0	0	1
Overall Study Withdrawal by Subject	0	13	12

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Risk Group I n=54 Participants Group I: * Complete resection (margins: tonsil \>1mm, tongue \>3mm, pT1-2, pN0-2B), * No LVI, no PNI, \<3 positive nodes. * No ECS, No matted or Level \>III, Observation	Intermediate Risk Group II n=29 Participants Group II * Complete resection (margins: tonsil \<1mm, tongue \<1mm, pT1-2, pN0-2B), * +LVI, +PNI, \<3 positive nodes. ≤1mm ECS. Radiotherapy: Postoperative XRT 50 Gy	High Risk Group III n=29 Participants IIIA * 3+ nodes, no ECS \> 1mm * Contralateral or supraclavicular nodes IIIB: * Incomplete surgical resection with + surgical margins * ≥ 1 mm ECS * Matted nodes Concurrent Chemoradiation: CCRT with cisplatin 40mg/m2/week IV over approximately 30 minutes, mixed in 250ml normal saline Weekly on Monday or Tuesday any time, or Wednesday prior to radiation Postoperative XRT 56 Gy	Total n=112 Participants Total of all reporting groups
Age, Continuous	62 years n=54 Participants	68 years n=29 Participants	70 years n=29 Participants	66 years n=112 Participants
Sex/Gender, Customized Gender · Male	50 Participants n=54 Participants	20 Participants n=29 Participants	26 Participants n=29 Participants	96 Participants n=112 Participants
Sex/Gender, Customized Gender · Female	4 Participants n=54 Participants	9 Participants n=29 Participants	3 Participants n=29 Participants	16 Participants n=112 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 5 years

Outcome measures

Outcome measures
Measure	Low Risk Group I n=31 Participants Group I: * Complete resection (margins: tonsil \>1mm, tongue \>3mm, pT1-2, pN0-2B), * No LVI, no PNI, \<3 positive nodes. * No ECS, No matted or Level \>III, Observation	Intermediate Risk Group II n=16 Participants Group II * Complete resection (margins: tonsil \<1mm, tongue \<1mm, pT1-2, pN0-2B), * +LVI, +PNI, \<3 positive nodes. ≤1mm ECS. Radiotherapy: Postoperative XRT 50 Gy in 25 fractions	High Risk Group III n=16 Participants IIIA * 3+ nodes, no ECS \> 1mm * Contralateral or supraclavicular nodes IIIB: * Incomplete surgical resection with + surgical margins * ≥ 1 mm ECS * Matted nodes Concurrent Chemoradiation: CCRT with cisplatin 40mg/m2/week IV over approximately 30 minutes, mixed in 250ml normal saline Weekly on Monday or Tuesday any time, or Wednesday prior to radiation Postoperative XRT 56 Gy in 28 fractions
Disease Specific Survival (DSS)	29 participants	15 participants	15 participants

PRIMARY outcome

Timeframe: 5 years

Number of participants with HPV related oropharynx cancer treated with a de-intensified adjuvant protocol with status of progression-free survival. PFS calculated the time to biopsy confirmed recurrence or death from any cause.

Outcome measures

Outcome measures
Measure	Low Risk Group I n=31 Participants Group I: * Complete resection (margins: tonsil \>1mm, tongue \>3mm, pT1-2, pN0-2B), * No LVI, no PNI, \<3 positive nodes. * No ECS, No matted or Level \>III, Observation	Intermediate Risk Group II n=16 Participants Group II * Complete resection (margins: tonsil \<1mm, tongue \<1mm, pT1-2, pN0-2B), * +LVI, +PNI, \<3 positive nodes. ≤1mm ECS. Radiotherapy: Postoperative XRT 50 Gy in 25 fractions	High Risk Group III n=16 Participants IIIA * 3+ nodes, no ECS \> 1mm * Contralateral or supraclavicular nodes IIIB: * Incomplete surgical resection with + surgical margins * ≥ 1 mm ECS * Matted nodes Concurrent Chemoradiation: CCRT with cisplatin 40mg/m2/week IV over approximately 30 minutes, mixed in 250ml normal saline Weekly on Monday or Tuesday any time, or Wednesday prior to radiation Postoperative XRT 56 Gy in 28 fractions
Number of Participants With Progression-Free Survival (PFS)	29 Participants	15 Participants	15 Participants

PRIMARY outcome

Timeframe: 5 years

the rate of local regional control (LRC) in patients with early and intermediate stage HPV related oropharynx cancer treated with surgery alone as assessed by number of participants with locoregional failures.

Outcome measures

Outcome measures
Measure	Low Risk Group I n=31 Participants Group I: * Complete resection (margins: tonsil \>1mm, tongue \>3mm, pT1-2, pN0-2B), * No LVI, no PNI, \<3 positive nodes. * No ECS, No matted or Level \>III, Observation	Intermediate Risk Group II n=16 Participants Group II * Complete resection (margins: tonsil \<1mm, tongue \<1mm, pT1-2, pN0-2B), * +LVI, +PNI, \<3 positive nodes. ≤1mm ECS. Radiotherapy: Postoperative XRT 50 Gy in 25 fractions	High Risk Group III n=16 Participants IIIA * 3+ nodes, no ECS \> 1mm * Contralateral or supraclavicular nodes IIIB: * Incomplete surgical resection with + surgical margins * ≥ 1 mm ECS * Matted nodes Concurrent Chemoradiation: CCRT with cisplatin 40mg/m2/week IV over approximately 30 minutes, mixed in 250ml normal saline Weekly on Monday or Tuesday any time, or Wednesday prior to radiation Postoperative XRT 56 Gy in 28 fractions
Number of Participants With Locoregional Failures (LRFs)	29 Participants	15 Participants	15 Participants

SECONDARY outcome

Timeframe: 5 years

Overall survival (OS) in patients with early and intermediate stage HPV related oropharynx cancer treated with surgery alone. OS from the time of entry to death with any cause.

Outcome measures

Outcome measures
Measure	Low Risk Group I n=31 Participants Group I: * Complete resection (margins: tonsil \>1mm, tongue \>3mm, pT1-2, pN0-2B), * No LVI, no PNI, \<3 positive nodes. * No ECS, No matted or Level \>III, Observation	Intermediate Risk Group II n=16 Participants Group II * Complete resection (margins: tonsil \<1mm, tongue \<1mm, pT1-2, pN0-2B), * +LVI, +PNI, \<3 positive nodes. ≤1mm ECS. Radiotherapy: Postoperative XRT 50 Gy in 25 fractions	High Risk Group III n=16 Participants IIIA * 3+ nodes, no ECS \> 1mm * Contralateral or supraclavicular nodes IIIB: * Incomplete surgical resection with + surgical margins * ≥ 1 mm ECS * Matted nodes Concurrent Chemoradiation: CCRT with cisplatin 40mg/m2/week IV over approximately 30 minutes, mixed in 250ml normal saline Weekly on Monday or Tuesday any time, or Wednesday prior to radiation Postoperative XRT 56 Gy in 28 fractions
Overall Survival	31 Participants	16 Participants	15 Participants

SECONDARY outcome

Timeframe: 5 years

Number of serious adverse events

Outcome measures

Outcome measures
Measure	Low Risk Group I n=31 Participants Group I: * Complete resection (margins: tonsil \>1mm, tongue \>3mm, pT1-2, pN0-2B), * No LVI, no PNI, \<3 positive nodes. * No ECS, No matted or Level \>III, Observation	Intermediate Risk Group II n=16 Participants Group II * Complete resection (margins: tonsil \<1mm, tongue \<1mm, pT1-2, pN0-2B), * +LVI, +PNI, \<3 positive nodes. ≤1mm ECS. Radiotherapy: Postoperative XRT 50 Gy in 25 fractions	High Risk Group III n=16 Participants IIIA * 3+ nodes, no ECS \> 1mm * Contralateral or supraclavicular nodes IIIB: * Incomplete surgical resection with + surgical margins * ≥ 1 mm ECS * Matted nodes Concurrent Chemoradiation: CCRT with cisplatin 40mg/m2/week IV over approximately 30 minutes, mixed in 250ml normal saline Weekly on Monday or Tuesday any time, or Wednesday prior to radiation Postoperative XRT 56 Gy in 28 fractions
Number of Serious Adverse Events	1 events	0 events	2 events

SECONDARY outcome

Timeframe: 2 years

Global Quality of Life Scores total score from 0-100, with higher score indicating better health outcomes.

Outcome measures

Outcome measures
Measure	Low Risk Group I n=31 Participants Group I: * Complete resection (margins: tonsil \>1mm, tongue \>3mm, pT1-2, pN0-2B), * No LVI, no PNI, \<3 positive nodes. * No ECS, No matted or Level \>III, Observation	Intermediate Risk Group II n=16 Participants Group II * Complete resection (margins: tonsil \<1mm, tongue \<1mm, pT1-2, pN0-2B), * +LVI, +PNI, \<3 positive nodes. ≤1mm ECS. Radiotherapy: Postoperative XRT 50 Gy in 25 fractions	High Risk Group III n=16 Participants IIIA * 3+ nodes, no ECS \> 1mm * Contralateral or supraclavicular nodes IIIB: * Incomplete surgical resection with + surgical margins * ≥ 1 mm ECS * Matted nodes Concurrent Chemoradiation: CCRT with cisplatin 40mg/m2/week IV over approximately 30 minutes, mixed in 250ml normal saline Weekly on Monday or Tuesday any time, or Wednesday prior to radiation Postoperative XRT 56 Gy in 28 fractions
Global Quality of Life Scores baseline, prior to surgery	89 score on a scale (MDADI score) Standard Deviation 5	89 score on a scale (MDADI score) Standard Deviation 4	89 score on a scale (MDADI score) Standard Deviation 12
Global Quality of Life Scores 3 months	89 score on a scale (MDADI score) Standard Deviation 6	76 score on a scale (MDADI score) Standard Deviation 6	63 score on a scale (MDADI score) Standard Deviation 10
Global Quality of Life Scores 6 months	89 score on a scale (MDADI score) Standard Deviation 4	85 score on a scale (MDADI score) Standard Deviation 4	71 score on a scale (MDADI score) Standard Deviation 13
Global Quality of Life Scores 1 year	89 score on a scale (MDADI score) Standard Deviation 4	85 score on a scale (MDADI score) Standard Deviation 6	78 score on a scale (MDADI score) Standard Deviation 9
Global Quality of Life Scores 2 years	89 score on a scale (MDADI score) Standard Deviation 3	85 score on a scale (MDADI score) Standard Deviation 6	88 score on a scale (MDADI score) Standard Deviation 9

Adverse Events

Low Risk Group I

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Intermediate Risk Group II

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

High Risk Group III

Serious events: 2 serious events

Other events: 16 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Low Risk Group I n=31 participants at risk Group I: * Complete resection (margins: tonsil \>1mm, tongue \>3mm, pT1-2, pN0-2B), * No LVI, no PNI, \<3 positive nodes. * No ECS, No matted or Level \>III, Observation	Intermediate Risk Group II n=16 participants at risk Group II * Complete resection (margins: tonsil \<1mm, tongue \<1mm, pT1-2, pN0-2B), * +LVI, +PNI, \<3 positive nodes. ≤1mm ECS. Radiotherapy: Postoperative XRT 50 Gy	High Risk Group III n=16 participants at risk IIIA * 3+ nodes, no ECS \> 1mm * Contralateral or supraclavicular nodes IIIB: * Incomplete surgical resection with + surgical margins * ≥ 1 mm ECS * Matted nodes Concurrent Chemoradiation: CCRT with cisplatin 40mg/m2/week IV over approximately 30 minutes, mixed in 250ml normal saline Weekly on Monday or Tuesday any time, or Wednesday prior to radiation Postoperative XRT 56 Gy
Blood and lymphatic system disorders Bleeding	3.2% 1/31 • 5 years Definitions do not differ from clinical.trials.gov definitions.	0.00% 0/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.	12.5% 2/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.

Other adverse events

Additional Information

Dr. Raymond L Chai

Icahn School of Medicine at Mount Sinai

Phone: (212) 844-8775

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Low Risk Group I n=31 participants at risk Group I: * Complete resection (margins: tonsil \>1mm, tongue \>3mm, pT1-2, pN0-2B), * No LVI, no PNI, \<3 positive nodes. * No ECS, No matted or Level \>III, Observation	Intermediate Risk Group II n=16 participants at risk Group II * Complete resection (margins: tonsil \<1mm, tongue \<1mm, pT1-2, pN0-2B), * +LVI, +PNI, \<3 positive nodes. ≤1mm ECS. Radiotherapy: Postoperative XRT 50 Gy	High Risk Group III n=16 participants at risk IIIA * 3+ nodes, no ECS \> 1mm * Contralateral or supraclavicular nodes IIIB: * Incomplete surgical resection with + surgical margins * ≥ 1 mm ECS * Matted nodes Concurrent Chemoradiation: CCRT with cisplatin 40mg/m2/week IV over approximately 30 minutes, mixed in 250ml normal saline Weekly on Monday or Tuesday any time, or Wednesday prior to radiation Postoperative XRT 56 Gy
General disorders dysphagia	32.3% 10/31 • 5 years Definitions do not differ from clinical.trials.gov definitions.	0.00% 0/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.	100.0% 16/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.
General disorders severe pain	25.8% 8/31 • 5 years Definitions do not differ from clinical.trials.gov definitions.	62.5% 10/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.	100.0% 16/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.
Psychiatric disorders anxiety	9.7% 3/31 • 5 years Definitions do not differ from clinical.trials.gov definitions.	0.00% 0/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.	0.00% 0/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.
General disorders xerostomia	9.7% 3/31 • 5 years Definitions do not differ from clinical.trials.gov definitions.	62.5% 10/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.	0.00% 0/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.
Surgical and medical procedures postoperative bleed	3.2% 1/31 • 5 years Definitions do not differ from clinical.trials.gov definitions.	0.00% 0/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.	6.2% 1/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.
Surgical and medical procedures velopharyngeal insufficiency	3.2% 1/31 • 5 years Definitions do not differ from clinical.trials.gov definitions.	0.00% 0/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.	0.00% 0/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.
General disorders altered taste/dysgeusia	0.00% 0/31 • 5 years Definitions do not differ from clinical.trials.gov definitions.	93.8% 15/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.	0.00% 0/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.
Surgical and medical procedures numbness of the neck	0.00% 0/31 • 5 years Definitions do not differ from clinical.trials.gov definitions.	18.8% 3/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.	0.00% 0/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.
General disorders lack of appetite	0.00% 0/31 • 5 years Definitions do not differ from clinical.trials.gov definitions.	18.8% 3/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.	0.00% 0/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.
General disorders dysarthria	0.00% 0/31 • 5 years Definitions do not differ from clinical.trials.gov definitions.	0.00% 0/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.	50.0% 8/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.
General disorders mucositis	0.00% 0/31 • 5 years Definitions do not differ from clinical.trials.gov definitions.	0.00% 0/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.	93.8% 15/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.
Metabolism and nutrition disorders >20-lb weight loss	0.00% 0/31 • 5 years Definitions do not differ from clinical.trials.gov definitions.	0.00% 0/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.	6.2% 1/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.
Respiratory, thoracic and mediastinal disorders pulmonary embolism	0.00% 0/31 • 5 years Definitions do not differ from clinical.trials.gov definitions.	0.00% 0/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.	6.2% 1/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.
Surgical and medical procedures hematoma	0.00% 0/31 • 5 years Definitions do not differ from clinical.trials.gov definitions.	0.00% 0/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.	6.2% 1/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.
Blood and lymphatic system disorders neutropenia	0.00% 0/31 • 5 years Definitions do not differ from clinical.trials.gov definitions.	0.00% 0/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.	18.8% 3/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.
Blood and lymphatic system disorders thrombocytopenia	0.00% 0/31 • 5 years Definitions do not differ from clinical.trials.gov definitions.	0.00% 0/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.	18.8% 3/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.
Metabolism and nutrition disorders dehydration	0.00% 0/31 • 5 years Definitions do not differ from clinical.trials.gov definitions.	0.00% 0/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.	6.2% 1/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.
Ear and labyrinth disorders tinnitus	0.00% 0/31 • 5 years Definitions do not differ from clinical.trials.gov definitions.	0.00% 0/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.	12.5% 2/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.
Renal and urinary disorders creatinine elevation	0.00% 0/31 • 5 years Definitions do not differ from clinical.trials.gov definitions.	0.00% 0/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.	6.2% 1/16 • 5 years Definitions do not differ from clinical.trials.gov definitions.