Symptoms and General Pathology

All Conditions

Neoplasms

Recurrence

Head and Neck Neoplasms

Disease Attributes

Report of disease-free survival at 2 years for patients with HNC recurrence treated with TORS

John Hardman

Marta Vergnano

Ann Gandolfi

transoral Robotic surgery for rECurrent tumours of the Upper aerodigestive Tract

Head and neck cancer (HNC) is the 6th most common type of cancer in the world and is increasing in incidence. Squamous cell carcinomas (SCC) account for the majority of these HNCs. An increasing number of these SCCs are being found to be associated with the Human Papilloma Virus (HPV) which has also been shown to be associated with a more favourable outcome. These HPV related cancers tend to affect younger patients with fewer comorbidities. As such, we are finding a larger cohort of patients are surviving for longer after treatment for their primary cancers.

HNC patients are over 11 times more likely to experience a second head and neck primary cancer than the general population over 20 years of follow up (SIR 11.2, 95% CI \[10.6-11.8\]). In addition to second primaries, patients may suffer from residual disease after treatment for their initial primary, identified within a 12 month period, or recurrent disease, cancer at the same site identified within 5 years. Treatment for all of these cancers, which we will broadly term 'recurrent' cancers for the purposes of this study, can be complex. Commonly, radiotherapy will have formed part of the treatment regime at either the primary site or to the neck for these patients. Radiotherapy causes fibrosis in the irradiated tissues, reducing tissue pliability, contributing to trismus and reducing healing potential at the effected sites. This can pose significant challenges to any further surgical intervention, which may form the mainstay of any subsequent management if re-irradiation is not an option or not indicated. Surgery must then look to be as minimally invasive as possible in order to maximise functional outcomes and reduce disruption of affected tissues.

Options for surgery have traditionally involved transmandibular and transcervical routes. More recently transoral routes have been adopted as endoscopic instruments become more widely available and adopted. Transoral Robotic Surgery (TORS) is the latest development in the field which confers some significant advantages to the surgeon and to the patient. For the surgeon, the endoscopic view is binocular, giving a close objective lens and excellent depth perception. Further, the instruments have wrists which sit within the body cavity, allowing manipulation of the tissues beyond the direct line of sight through the oral stoma. For the patient, there is less disrupted tissue if access incisions are avoided, reducing the volume of tissue that would be susceptible to scarring which can affect swallowing function or lead to fistula formation.

However, there are little data to show oncological and functional outcomes are acceptable following TORS surgery for recurrent cancers. This is in part as it is a relatively new technology and in part because whilst increasingly common, the absolute number of surgeries performed remains relatively low at individual centres. Published outcomes have shown 2 year disease-free survival rates around 75%. The RECUT study aims to use a collaborative methodology to document the outcomes from TORS for recurrent HNC being performed at a number of high volume centres across the globe.

Transoral Robotic Surgery for rECurrent Tumours of the Upper Aerodigestive Tract

Royal Marsden NHS Foundation Trust

Carcinoma

Carcinoma, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Transoral robotic surgery (TORS) using Versius Surgical System. Versius is a robot designed to help surgeons perform surgery. It consists of a set of robotic arms: one of the arms has a camera and a light source on it while the other arms each have a small surgical instrument attached at the end. The surgeon controls each of the arms with hand controllers (joysticks) and can perform surgery with them, while seeing the surgical area on a screen in front of him/her.

The camera and instruments are inserted into the mouth and throat in order to cut out a cancerous tumour.

Versius Surgical System

Chad Schaber, PhD

Morad Nakhleh, PhD

Jason Fleming, MD PhD

Christopher Loh, MD

Katharine Davies, MD

This is a single-arm, single site, multi-surgeon prospective feasibility study for transoral robot assisted surgery (TORS) with the Versius Surgical System. Versius is a robotic system designed to help in the accurate control of surgical instruments for minimal access ("keyhole") surgery. In TORS procedures surgical instruments are inserted through the mouth/throat to remove sick tissue rather than through skin incisions. The primary objective of this study will be to evaluate the safe use and performance of the Versius in transoral surgeries. Pre-clinical work has been conducted to ensure TORS with Versius is viable and safe; this will be one of the first in-human studies of TORS with Versius. This study will focus specifically on patients with cancerous tumours of the oropharynx (the mouth/throat) that need to be surgically removed. The safety of Versius for TORS will be mainly assessed by the rate of complications/adverse events up to 30 days after surgery, and the performance will be mainly assessed by the number of TORS cases successfully completed with Versius (i.e. without having to switch to another surgical technique).

Prospective Clinical Study to Assess the Safety and Efficacy of Versius, in Transoral Robotic Surgery

To assess efficacy of TORS with Versius by the rate of successful completion of Transoral Robotic Surgery (TORS) without unplanned conversion to other transoral or open techniques

Time taken to complete surgery, excluding any reconstruction

Pain medication taken post-surgery converted to morphine equivalents

Length of post operative stay in hospital

Emergency re-operation after initial surgery

Amount of time after surgery before oral intake, including nasogastric tube requirement and length of use

Final pathological margin of resected specimens (mm)

Liverpool University Hospitals NHS Foundation Trust

Sintesi Research S.r.l.

CMR Surgical Ltd

Behaviors and Mental Disorders

Quality of Life

Patients operated by Trans-oral Robotic Surgery (TORS)

Patients operated by Trans-oral Laser Microsurgery (TLM)

Patients treated by Intensity Modulated Radiation Therapy (IMRT)

* Arm 1: Intensity-Modulated Radiation Therapy (IMRT)
* Arm 2: Trans-oral Laser Microsurgery (TLM)
* Arm 3: Trans-oral Robotic Surgery (TORS)

TORS

Hassid Samantha, Doctor

Hassid Dr Samantha, Doctor

In this project, the investigators will realize an observational, prospective, multicentric and international clinical trial, to objectively compare patients with SSCC according to 3 arms of treatment:

* Arm 1: Radiotherapy ± chemotherapy
* Arm 2: Trans-oral Laser Microsurgery (TLM)
* Arm 3: Trans-oral Robotic Surgery (TORS)

The main goal is to evaluate the efficacy of each treatment with four classes of outcomes:

* The quality of life (QoL) before and after each treatment option, using validated questionnaires
* Oncological outcomes
* Functional outcomes
* Economical Resources

The population will include cT1-T2 /cN0-N1/M0 supraglottic squamous cell carcinoma.

The primary outcome is a Clinical Dysphagia QoL evaluation assessed by the MD Anderson Dysphagia questionnaire. Secondary outcomes include others QoL evaluation, oncological and functional measures and cost parameters. The sample size needs to reach 36 patients per arm (total 108).

Treatment of Early Supraglottic Squamous Cell Carcinoma With Advance Technologies

Treatment of Supraglottic Squamous Cell Carcinoma With Advance Technologies: Observational Evaluation of Quality of Life, Oncological Outcomes, Functional Outcomes and Economical Resources

Clinical Dysphagia QoL evaluation after treatment will be assessed using MD Anderson Dysphagia Index (MDADI). MDADI consists of 20 items pooled in 4 subscales: the global scale (1 item); the functional scale (5 items); the physical scale (8 items); and the emotional scale (6 items). All items are scored on a 5-point scale (1-5), where "1" corresponds to "total agreement" and "5" to "total disagreement." All except 2 items were scored such that higher scores indicated higher functioning. Responses on all domains were summed to calculate the total score (MDADI-T). The maximum score is 100, indicating high functioning, and the minimum score is 20, indicating poor functioning.

QoL will be evaluated with the validated European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire It is composed on five functional scales (physical, performance, cognitive, emotional and social), three symptoms scale (fatigue, pain, nausea and vomiting), a global health status/QoL scale and 6 simple items for assessment of symptoms or additional problems (dyspnea, loss of appetite, insomnia, financial difficulties, constipation and diarrhea). All of the scale and single item measures range in score from 0 to 100. Regarding functional and overall health status scales, higher scores relate to better quality of life; however, for the scales of symptoms, higher scores correspond to the higher presence of this symptom and, consequently, the worse quality of life.

QoL will be evaluated with the validated European Organization for Research and Treatment of Cancer (EORTC) H\&N43 questionnaire It comprises 43 questions about symptoms and side effects of treatment, social function, body image and sexuality. It incorporates 12 symptom scales (pain, swallowing, problems with teeth, dry month and sticky saliva, problems with senses, speech, body image, social eating, sexuality, problems with shoulder, skin problems and fear of progression) and 7 simple items (problems opening mouth, coughing, social contact, swelling in the neck, weight loss, problem with wound healing and neurological problems). All of the scales and the single item measures range in score from 0 to 100. A high score represents a high level of symptomatology or problems.

Swallowing function by FEES evaluation (Fiberoptic Endoscopic Evaluation of Swallowing) objectively evaluated by the Penetration-aspiration Scale (PAS) The PAS is an 8-point scale that rates the degree of airway invasion. Score of 1 is normal, score between 2-5 represent laryngeal penetration and scores up to 6 indicate airway aspiration.

CTC-AE Score for early and late complication The Common Terminology Criteria for Adverse Events (CTC-AE) is a descriptive terminology which was published by the National Cancer Institute (NCI) as part of an ongoing effort to standardize adverse events (AE) reporting within oncology. AE are graded according to an ordinal scale where 1 represents asymptomatic or mild symptoms and 5 represents death from the AE. In between, 2 is moderate, 3 is severe, and 4 is life-threatening. E.g., with regard to dysphagia, the CTCAE uses the descriptive terminology listed in Table 1, columns 1 and 2. CTCAE dysphagia grades are based on symptoms, diet, and tube dependency. This scale will be filled in by the physician.

Naso-gastric Feeding tube and/or gastrostomy use (duration in days)

Need of hospitalization (yes or no; if yes, duration in days)

Centre Hospitalier Universitaire UCLouvain Namur

Professor

Squamous Cell Carcinoma of Head and Neck

* Complete resection to negative frozen section margins (pT1-2)
* \< 4 nodes, ≤ 2 mm extranodal extension (ENE), no supraclavicular nodes

Transoral robotic surgical resection of the tumor with negative intraoperative frozen section margins.

Robotic surgery

Tanvir Queraishi

Raymond Chai, MD

Raymond Chai

The purpose of this study is to determine whether treatment of HPV-related oropharyngeal squamous cell carcinoma in patients with undetectable postoperative HPV circulating tumor DNA (cfHPVDNA) with transoral robotic surgery (TORS) alone can result in cancer control and survival comparable to those previously reported with standard therapy. The protocol includes patients with only with low or intermediate pathologic risk factors following surgery with detectable pre-surgery cfHPVDNA and undetectable post-surgery cfHPVDNA.

The hope is that with this approach, the long-term complications from chemotherapy and radiation can be reduced.

There has been significant increase in the incidence of oropharynx cancer in North America and Europe. It is now understood that there are two dominant carcinogenic pathways for oropharyngeal squamous cell carcinoma. Environmentally related which is caused mainly by smoking and alcohol, and HPV-related oropharyngeal squamous cell carcinoma (HPVOPSCC). HPVOPSCC now accounts for over 80% of OPC seen in the USA and an increasing fraction of these malignancies in Europe. It has been shown that HPVOPSCC confers an excellent prognosis for intermediate staged disease and this has called into question the rational for aggressive concurrent chemoradiotherapy. High-dose radiotherapy (RT) and chemoradiotherapy (CRT) have substantial impact on local tissues and organ function and result in a significant rate of late mortality and morbidity. Studies are now being designed to reduce the impact of RT and CRT for patients.

Recently, a new test has been developed that measures HPV circulating tumor DNA (cfHPVDNA) in the blood. The test has emerged as a promising biomarker for HPVOPSCC, correlating with both treatment response as well as surveillance for cancer recurrence. Data suggests that a negative test in the surveillance period following treatment is highly sensitive and specific for recurrent disease.

In this trial, the study will be stratifying p16 positive patients with PCR detectable high-risk (HR) HPV DNA or RNA following TORS into risk groups based on final pathology to determine appropriate treatment intensity. Patients with low- or intermediate-risk pathologic disease and undetectable postoperative cfHPVDNA will receive no adjuvant therapy. This group includes patients with AJCC 7th edition T1-T2N0-2b disease. Patients must have less than four pathologic nodes on final pathology, negative margins, and no contralateral nodes. Perineural or lymphovascular alone is allowed but not in combination. Microscopic extranodal extension (less than or equal to 2 mm) is allowed. Patients cannot be active smokers or have a 20 or greater pack year history of smoking.

The Sinai Robotic Surgery Trial in HPV-related Oropharyngeal Squamous Cell Carcinoma (SIRS 2.0 Trial)

All of the individual participant data collected during the trial, after deidentification.

Local and/or regional disease recurrence (LRR) at 2 years

PFS at 2 years as defined as the proportion of patients without events (recurrence or death) at 2 years

OS at 2 years is defined as the proportion of patients alive at 2 years

20 items instrument: a global assessment (a single question), it comprises three subscales: the emotional subscale (8 items), the functional subscale (5 items), and the physical subscale (6 items). The global assessment refers to the individual's swallowing difficulty as it affects one's overall daily routine. The emotional, functional, and physical subscales refer to the individual's affective response to the swallowing disorder, the impact of the disorder on daily activities, and the self-perception of the swallowing difficulties, respectively. Using a five-point scale (1-5), the minimum total score is 20 and the maximum 100. Higher score indicates the least interference with daily life.

Scale range from 1-10 (1 being dry as a desert and 10 is normal). Higher score indicates better health outcomes

EORTC QLQ-C30 is a 30-question tool used to assess the overall QoL in cancer participants. It consisted of 15 domains: 1 GHS/QoL scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). Most items are scored 1 ("not at all") to 4 ("very much") except for the items contributing to the GHS/QoL, which are scored 1 ("very poor") to 7 ("excellent"). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100. For the GHS/QoL and 5 functional scales a high score indicates better global health status/functioning and a negative change from baseline indicated less improvement. Scale ranges from 0-100. For the symptom scales, a high score indicates a higher level of symptoms, and a negative change from baseline indicated an improvement in symptoms.

EORTC QLQ-H\&N35 is a 35-question site-specific tool and is used in conjunction with EORTC QLQ-C30 measurement tool. Scale range from 0-100. Higher score indicates poorer health outcomes.

MDASI-HN is a 28 symptom items questionnaire: 13 general cancer-related symptoms, such as pain, fatigue and nausea; 9 HNC-related symptoms, such as problems with mucus in the mouth and difficulty in swallowing or chewing; 6 items to evaluate the effects of symptoms on daily life, including mood and enjoyment of life. Each item is rated on a 11-point scale from 0 (not at all) to 10 (as bad as you can imagine), while the items that assess the interference of symptoms on daily activities are rated from 0 (does not interfere) to 10 (interfered completely). Subscales and full scale range from 0-10. Higher score indicates poorer health outcome.

Icahn School of Medicine at Mount Sinai

Associate Professor of Otolaryngology

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Mouth Diseases

Oropharyngeal Neoplasms

Laryngeal Diseases

Hypopharyngeal Neoplasms

Otorhinolaryngologic Diseases

Stomatognathic Diseases

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Subjects ≥ 22 yrs requiring transoral procedures

Michael D Tricoli, BS, MBA

The objectives of this study are to evaluate the performance of the Medrobotics Flex® Robotic System to visualize and access specific anatomical locations along with evaluation of the safety of the device.

A Post-Market Clinical Trial for Access and Visualization of the Oropharynx, Hypopharynx and Larynx During Transoral Procedures

A Multicenter OUS Post-Market Clinical Follow-Up of the Medrobotics Flex® Robotic System Used for Accessing and Visualizing the Oropharynx, Hypopharynx, and Larynx During Transoral Procedures

Ability to access and visualize all the following anatomical locations in the oropharynx, hypopharynx and larynx via transoral only approach. Palatine tonsils, base of tongue, epiglottis, posterior pharyngeal wall, false vocal cords.

Medrobotics Corporation

Rare Diseases

Mouth Neoplasms

Oral Cancer

Symptom questionnaires about symptoms of cancer and how they affect life at work and at home, diet, and speech completed at baseline, every week during IMPT, at 3 months, and at 6 months.

Dysphagia Inventory questionnaire about how difficult it is to swallow completed at baseline, every week during IMPT, at 3 months, and at 6 months.

Activity bands given to participant at baseline. Participant wears the band 24 hours a day for 1 week leading up to all study visits.

Symptom questionnaires about symptoms of cancer and how they affect life at work and at home, diet, and speech completed at baseline, after TORS, at 3 months, and at 6 months.

Dysphagia Inventory questionnaire about how difficult it is to swallow completed at baseline, after TORS, at 3 months, and at 6 months.

Activity bands given to participant at baseline. Participant wears the band 24 hours a day for 1 week leading up to all study visits.

Intensity-Modulated Proton Therapy or( IMPT) Group: Symptom questionnaires about symptoms of cancer and how they affect life at work and at home, diet, and speech completed at baseline, every week during IMPT, at 3 months, and at 6 months.

TransOral Robotic Surgery (TORS) Group: Symptom questionnaires about symptoms of cancer and how they affect life at work and at home, diet, and speech completed at baseline, after TORS, at 3 months, and at 6 months.

Symptom Questionnaires

Intensity-Modulated Proton Therapy or( IMPT) Group: Dysphagia Inventory questionnaire about how difficult it is to swallow completed at baseline, every week during IMPT, at 3 months, and at 6 months.

TransOral Robotic Surgery (TORS) Group: Dysphagia Inventory questionnaire about how difficult it is to swallow completed at baseline, after TORS, at 3 months, and at 6 months.

Dysphagia Inventory Questionnaire

Activity bands given to participant at baseline. Participant wears the band 24 hours a day for 1 week leading up to all study visits.

Activity Bands

Neil Gross, MD

MD Anderson Health Information Specialist

The goal of this laboratory research study is to learn about symptoms and activity levels of patients with OPSCC that receive IMPT or TORS.

Baseline Visit:

If participant agrees to take part in this study, they will complete the following tests and procedures at their baseline visit. This baseline visit will take place before participant's treatment with IMPT or TORS:

* Participant will complete questionnaires about any symptoms of cancer they may be having and how they affect their daily life at work and at home, their diet, and their speech.
* Participant will complete the Dysphagia Inventory. This is a questionnaire about how difficult it is to swallow.
* The study staff will measure how wide participant can open their jaw to see if their treatment may cause any jaw opening limitations.

It should take about 30 minutes to complete all of the questionnaires.

As part of participant's baseline visit, information below will be collected from their medical record:

* Participant's medical history
* The results of participant's physical exam including their weight and any recent weight loss.
* Any other diseases participant may have and any drugs they are currently taking.
* Participant's current smoking status and smoking history.

Activity Bands:

The study staff will either give participant an activity band at their baseline visit or they will be mailed an activity wristband. Participant will be asked to wear the band 24 hours a day for 1 week leading up to all study visits. The wristband will record how active participant is and how much they sleep. The study staff will show participant how to wear and use the wristband.

Study Visits:

Participant will complete the following study procedures after they complete treatment with either IMPT or TORS, and at 3 and 6 months after that.

* The data from participant's wristband will be collected.
* Participant will complete the same questionnaires they did at baseline.
* At participant's 3 month visit only, the study staff will measure how wide they can open their jaw to see if their treatment may cause any jaw opening limitations.

IMPT patients only:

If participant is receiving IMPT, they will complete the questionnaires they completed at the baseline visit once a week while they are receiving treatment.

Length of Study:

Participant's active participation in this study will be over after the 6 month study visit.

Participant will return the wristband to the study staff after their participation is over. If participant loses or damages the wristband while they are on study, another one will be provided to them at no cost.

This is an investigational study.

Up to 44 participants will take part in this study. All will be enrolled at MD Anderson.

Intensity-Modulated Proton Therapy (IMPT) or TransOral Robotic Surgery (TORS) for the Treatment of Low-Risk Oropharynx Squamous Cell

Observational Parallel Cohort Study of Intensity-Modulated Proton Therapy (IMPT) or TransOral Robotic Surgery (TORS) for the Treatment of Low-Risk Oropharynx Squamous Cell Carcinoma

Functional outcome measured by using longitudinal digital wristband activity monitoring of study participants.

Functional outcome measured by using patient-reported outcome (PRO) measures from the M.D. Anderson Symptom Inventory for Head and Neck Cancer (MDADI-HN).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Transoral Robotic Surgery for rECurrent Tumours of the Upper Aerodigestive Tract	NCT04673929	Recurrent Head ...		18 Years -	Royal Marsden NHS Foundation Trust
Prospective Clinical Study to Assess the Safety and Efficacy of Versius, in Transoral Robotic Surgery	NCT06112535	Squamous Cell C... Squamous Cell C...	Versius Surgica...	18 Years -	CMR Surgical Ltd
Treatment of Early Supraglottic Squamous Cell Carcinoma With Advance Technologies	NCT05611515	Supraglottic Sq... Early Stage (T1...	TORS	18 Years -	Centre Hospitalier Universitaire UCLouvain Namur
The Sinai Robotic Surgery Trial in HPV-related Oropharyngeal Squamous Cell Carcinoma (SIRS 2.0 Trial)	NCT05419089	HPV-positive Or...	Robotic surgery	18 Years -	Icahn School of Medicine at Mount Sinai
A Post-Market Clinical Trial for Access and Visualization of the Oropharynx, Hypopharynx and Larynx During Transoral Procedures	NCT02262247	OSA Oral Disease Oropharyngeal N... Hypopharyngeal ...		22 Years -	Medrobotics Corporation
The Sinai Robotic Surgery Trial in HPV-related Oropharyngeal Squamous Cell Carcinoma (SIRS 2.0 Trial)	NCT05419089	HPV-positive Or...	Robotic surgery	18 Years -	Icahn School of Medicine at Mount Sinai
Intensity-Modulated Proton Therapy (IMPT) or TransOral Robotic Surgery (TORS) for the Treatment of Low-Risk Oropharynx Squamous Cell	NCT02663583	Cancer of the M... Oropharynx Squa...	Symptom Questio... Dysphagia Inven... Activity Bands	18 Years -	M.D. Anderson Cancer Center
Intensity-Modulated Proton Therapy (IMPT) or TransOral Robotic Surgery (TORS) for the Treatment of Low-Risk Oropharynx Squamous Cell	NCT02663583	Cancer of the M... Oropharynx Squa...	Symptom Questio... Dysphagia Inven... Activity Bands	18 Years -	M.D. Anderson Cancer Center
Transoral Robotic Surgery for rECurrent Tumours of the Upper Aerodigestive Tract	NCT04673929	Recurrent Head ...		18 Years -	Royal Marsden NHS Foundation Trust

Spots Global Cancer Trial Database for tors

Every month we try and update this database with for tors cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tors

Every month we try and update this database with for tors cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tors cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.