Oropharyngeal CancerNCT03049280

Prospective, Multicenter da Vinci® SP™ Surgical System TORS Study

A study testing Transoral robotic surgery in people with Oropharyngeal Cancer, run by Intuitive Surgical at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A prospective, multicenter investigation of the da Vinci® SP™ Surgical System in Transoral Robotic Surgery (TORS) procedures for malignant oropharyngeal tumors. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Oropharyngeal Cancer
What is being tested?: Transoral robotic surgery
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 3 sitesUnited States
Study dates: 17 Apr 2017to 26 Dec 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18 years or older
T1 or T2 malignant oropharyngeal tumor
Tumor amenable to transoral resection
No previous treatment for the index tumor
Willing and able to provide written informed consent
Willing and able to comply with the study protocol requirements

Who cannot join

T3 or T4 stage tumor
Previous radiation treatment to the head and neck, with or without chemotherapy
Evidence of other primary cancers or distant metastasis or subject with synchronous primary tumor excluding skin cancers
Pre-operative expectation of needing microvascular soft-tissue reconstruction
Tumor that invades and/or abuts the internal and/or external carotid artery
Retropharyngeal carotid artery coincident with a tonsillar cancer or posterior pharyngeal wall cancer

Show all 12Show fewer

Evidence of mandibular invasion of tumor
Eastern Cooperative Oncology Group Performance Status score greater than or equal to 2
On a medication that interferes with clotting that cannot be stopped prior to surgery
Contraindication for general anesthesia or surgery
Mentally handicapped or has psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent
Pregnant or suspected to be pregnant

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Florida Hospital
Celebration, Florida, 34747
Board of Trustees of the Leland Stanford Junior University
Palo Alto, California, 94304
Trustees of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: A Prospective, Multicenter Investigation of the da Vinci® SP™ Surgical System in TORS Procedures for Resection of Malignant Tumors

A prospective, multicenter investigation of the da Vinci® SP™ Surgical System in Transoral Robotic Surgery (TORS) procedures for malignant oropharyngeal tumors.

Read the detailed description

A prospective, multicenter investigation to evaluate the safety and clinical performance of the da Vinci SP Surgical System, instruments, and accessories in TORS procedures for malignant oropharyngeal tumors classified as T1 and T2.

Conditions: Oropharyngeal Cancer
Being tested: Transoral robotic surgery
Medical subject headings: Oropharyngeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transoral robotic surgeryDevice
Transoral robotic surgery for T1 \& T2 oropharyngeal cancers

Study groups in NCT03049280
Study group	Role	What they receive
Transoral robotic surgery	Experimental	Not described Receives: Device: Transoral robotic surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Performance
Performance defined as the conversion to an open approach required to complete the procedure
Measured: Intraoperative
Number of Subjects With Device-related Serious Adverse Events
Safety is determined by measuring the number of subjects that experience device-related serious adverse events
Measured: Intraoperative period

Secondary outcomes (1)

Positive Surgical Margin
Rate of final positive surgical margins confirmed by pathology
Measured: Through14-days postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Apr 201726 Dec 2017

First posted10 Feb 2017
Study start17 Apr 2017
Primary completion14 Nov 2017
Study completion26 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Oropharyngeal CancerStudies of the same condition, open and under way.
More trials run by Intuitive SurgicalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03049280
Sponsor's protocol ID: ISI dV SP-TORS - 01
Status last verified: Sep 2020
First submitted: 30 Jan 2017
Last updated: 6 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Holsinger FC, Magnuson JS, Weinstein GS, Chan JYK, Starmer HM, Tsang RKY, Wong EWY, Rassekh CH, Bedi N, Hong SSY, Orosco R, O'Malley BW Jr, Moore EJ. A Next-Generation Single-Port Robotic Surgical System for Transoral Robotic Surgery: Results From Prospective Nonrandomized Clinical Trials. JAMA Otolaryngol Head Neck Surg. 2019 Nov 1;145(11):1027-1034. doi: 10.1001/jamaoto.2019.2654.
PubMed 31536129

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Camonsertib, to Radiation Therapy for Recurrent Head and Neck Squamous Cell Carcinoma
Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Recurrent Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
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All Oropharyngeal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multicenter Investigation of the da Vinci® SP™ Surgical System in TORS Procedures for Resection of Malignant Tumors
ClinicalTrials.gov ID: NCT03049280
Acronym / sponsor ID: ISI dV SP-TORS - 01
Conditions: Oropharyngeal Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Intuitive SurgicalIndustry (pharma, biotech, devices)
Study start: 17 Apr 2017 (actual)
Primary completion: 14 Nov 2017 (actual)
Study completion: 26 Dec 2017 (actual)
First posted: 10 Feb 2017 (actual)
Results: Posted 18 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A prospective, multicenter investigation of the da Vinci® SP™ Surgical System in Transoral Robotic Surgery (TORS) procedures for malignant oropharyngeal tumors.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Transoral robotic surgery	Experimental	Device: Transoral robotic surgery

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

18 years or older
T1 or T2 malignant oropharyngeal tumor
Tumor amenable to transoral resection
No previous treatment for the index tumor
Willing and able to provide written informed consent

Key exclusion criteria (12 listed)

T3 or T4 stage tumor
Previous radiation treatment to the head and neck, with or without chemotherapy
Evidence of other primary cancers or distant metastasis or subject with synchronous primary tumor excluding skin cancers
Pre-operative expectation of needing microvascular soft-tissue reconstruction
Tumor that invades and/or abuts the internal and/or external carotid artery

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transoral robotic surgeryTransoral robotic surgery for T1 \& T2 oropharyngeal cancers	Device	Transoral robotic surgery

Primary outcome

Performance
Time frame: Intraoperative
Performance defined as the conversion to an open approach required to complete the procedure
Number of Subjects With Device-related Serious Adverse Events
Time frame: Intraoperative period
Safety is determined by measuring the number of subjects that experience device-related serious adverse events

1 secondary outcome

Positive Surgical Margin
Time frame: Through14-days postoperatively

Results and safety

Results posted to the registry on 18 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TORS	33	32

Primary outcome: Performance

Time frame: Intraoperative. Count of participants. Unit: Participants

Measure	TORS n = 33
Value	0

Population analysed: all subjects that were eligible to participate and underwent TORS

Primary outcome: Number of Subjects With Device-related Serious Adverse Events

Time frame: Intraoperative period. Count of participants. Unit: Participants

Measure	TORS n = 33
Value	0

Population analysed: Subject that were eligible to participate and underwent TORS

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected during the conduct of the study and through 7 weeks follow-up. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TORS	4 of 33 (12.1%)	4 of 33 (12.1%)	0 of 33

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31536129Holsinger FC, Magnuson JS, Weinstein GS, Chan JYK, Starmer HM, Tsang RKY, Wong EWY, Rassekh CH, Bedi N, Hong SSY, Orosco R, O'Malley BW Jr, Moore EJ. A Next-Generation Single-Port Robotic Surgical System for Transoral Robotic Surgery: Results From Prospective Nonrandomized Clinical Trials. JAMA Otolaryngol Head Neck Surg. 2019 Nov 1;145(11):1027-1034. doi: 10.1001/jamaoto.2019.2654.
Individual participant dataSharing planned: No

Related trials for Oropharyngeal Cancer

RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2/3
FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC
Metastatic Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Camonsertib, to Radiation Therapy for Recurrent Head and Neck Squamous Cell Carcinoma
Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Recurrent Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
RecruitingPhase 2
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Cervical Cancer, Throat Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christopher Holsinger, MD principal investigator

Stanford University

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Transoral robotic surgery in people with Oropharyngeal Cancer, run by Intuitive Surgical at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Performance (time frame: Intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03049280, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020.