Robotic Surgery + Radiation Therapy for Throat Cancer
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Icahn School of Medicine at Mount Sinai
Must not be taking: Chemotherapy, Anti TNF agents
Disqualifiers: Pregnancy, Other malignancies, Unstable cardiac, others
No Placebo Group
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, you cannot participate if you are currently receiving any other anti-cancer therapy or have been in an investigational drug trial within 30 days of joining this study.
What data supports the effectiveness of the treatment Robotic Surgery + Radiation Therapy for Throat Cancer?
Research shows that transoral robotic surgery (TORS) is effective for treating oropharyngeal squamous cell carcinoma, achieving high rates of successful tumor removal and good long-term survival outcomes. Additionally, TORS combined with radiotherapy has been shown to be effective for early-stage throat cancers, providing good oncological and functional results.
12345Is robotic surgery safe for treating throat cancer?
Transoral robotic surgery (TORS) has been shown to be a safe method for treating oropharyngeal cancers, with studies supporting its safety and effectiveness compared to traditional open surgery. It uses precise instruments and improved visualization to minimize complications.
26789How does the treatment of robotic surgery combined with radiation therapy for throat cancer differ from other treatments?
Robotic surgery (TORS) for throat cancer is unique because it is a minimally invasive procedure that allows precise removal of tumors through the mouth, potentially reducing the need for extensive radiation or chemotherapy. This approach can lead to better functional outcomes, such as preserving swallowing and speech, compared to traditional open surgery or chemoradiation.
210111213Eligibility Criteria
This trial is for adults over 18 with HPV-related oropharyngeal cancer who have never had head and neck cancer treatments, don't currently smoke, and have a light smoking history. They must have no detectable HPV DNA in their blood after surgery, be generally healthy, and have good organ function.Inclusion Criteria
I have smoked 20 or fewer pack-years and I don't smoke now.
I have not had surgery, radiation, or chemo for head/neck cancer.
My cancer is in an early or intermediate stage without spread to distant areas.
+7 more
Exclusion Criteria
Other serious illnesses or medical conditions
I have had cancer before, but it was treated and has been gone for over 3 years, except for certain types like skin or thyroid cancer.
My cancer has spread to many neck nodes or cannot be fully removed by surgery.
+8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Surgery
Participants undergo transoral robotic surgery (TORS) for resection of HPV-related oropharyngeal squamous cell carcinoma
1 week
1 visit (in-person)
Post-Surgery Monitoring
Participants are monitored for postoperative cfHPVDNA levels to determine the need for further treatment
4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of local and/or regional disease recurrence
2 years
Participant Groups
The study tests if robotic surgery alone or combined with lower doses of radiation and chemotherapy can control cancer as effectively as standard treatments in patients without detectable HPV DNA post-surgery.
1Treatment groups
Experimental Treatment
Group I: Robotic surgery onlyExperimental Treatment1 Intervention
* Complete resection to negative frozen section margins (pT1-2)
* \< 4 nodes, ≤ 2 mm extranodal extension (ENE), no supraclavicular nodes
Robotic surgery is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Transoral Robotic Surgery for:
- Oropharyngeal squamous cell carcinoma
- Head and neck cancers
🇪🇺 Approved in European Union as TORS for:
- Oropharyngeal squamous cell carcinoma
- Head and neck cancers
🇨🇦 Approved in Canada as Transoral Robotic Surgery for:
- Oropharyngeal squamous cell carcinoma
- Head and neck cancers
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Valley - Mount Sinai Comprehensive Cancer CareParamus, NJ
Mount Sinai Health SystemNew York, NY
Loading ...
Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
References
Long-term functional and oncologic results of transoral robotic surgery for oropharyngeal squamous cell carcinoma. [2022]To examine the long-term functional and oncologic results in patients who underwent transoral robotic surgery (TORS) as primary therapy or as part of combined therapy for oropharyngeal squamous cell carcinoma arising in the tonsil or base of tongue.
Long-term survival outcomes after primary transoral robotic surgery (TORS) with concurrent neck dissection for early-stage oropharyngeal squamous cell carcinoma. [2022]In 2013, transoral robotic surgery (TORS) was implemented as a protocolled treatment alternative to the traditional radiotherapy (RT) in Denmark for oropharyngeal squamous cell carcinoma (OPSCC). In 2017, we published our first prospective feasibility study, showing that TORS with concurrent neck dissection successfully achieved negative margins in 29 out of 30 patients (97%) with early-stage OPSCC.
Survival and Swallowing Function after Primary Radiotherapy versus Transoral Robotic Surgery for Human Papillomavirus-Associated Oropharyngeal Squamous Cell Carcinoma. [2023]The aim of this study was to investigate the impact of primary transoral robotic surgery (TORS) versus radiotherapy (RT) on progression-free survival (PFS), overall survival (OS), and 1-year swallowing function for patients with early-stage HPV-associated oropharyngeal squamous cell carcinoma (OPSCC).
A systematic review of transoral robotic surgery and radiotherapy for early oropharynx cancer: a systematic review. [2021]To demonstrate the comparative effectiveness of transoral robotic surgery (TORS) to intensity modulated radiotherapy (IMRT) for early T-stage oropharyngeal cancer.
Oncological outcome following initiation of treatment for stage III and IV HPV negative oropharyngeal cancers with transoral robotic surgery (TORS). [2020]To report long-term oncological and functional outcome of Transoral Robotic Surgery escalated treatment including radiotherapy or chemoradiotherapy for Stage III-IV HPV negative oropharyngeal malignancies.
Transoral robotic surgery adoption and safety in treatment of oropharyngeal cancers. [2023]Transoral robotic surgery (TORS) was approved by the Food and Drug Administration in 2009 for the treatment of oropharyngeal cancers (oropharyngeal squamous cell carcinoma [OPSCC]). This study investigated the adoption and safety of TORS.
Analysis of T1-T2 stage oropharyngeal squamous cell carcinoma treated with transoral robotic surgery. [2023]Transoral robotic surgery (TORS) has become an effective treatment for early-stage oropharyngeal squamous cell carcinomas (OPSCCs). We aimed to analyze the clinical safety and efficacy of TORS for human papilloma virus (HPV)-positive and HPV-negative OPSCC in China.
Is There a Role for Robotic Surgery in the Treatment of Head and Neck Cancer? [2018]Given the potential for long-term toxicities from concurrent chemoradiation, there is great interest in surgery as a primary treatment modality for head and neck cancers, particularly in the younger HPV-positive oropharyngeal cancer patient. Transoral robotic surgery (TORS) has proven to be an effective technique to safely treat oropharyngeal and select supraglottic tumors surgically. Sound, traditional surgical principles are employed using improved endoscopic visualization and precise instrumentation to perform oncologic surgery without the morbidity of transmandibular or transcervical approaches. Although level 1 evidence prospective clinical trials are currently underway for TORS, the literature supports its safety and efficacy based on numerous studies. Currently, prospective randomized trials are underway to provide better evidence for or against TORS in oropharyngeal cancer. Patient selection based on comorbidities, anatomy, and available pathological data is critical in choosing patients for TORS.
Transoral robotic surgery vs open surgery in head and neck cancer. A systematic review of the literature. [2022]TORS has become one of the latest surgical alternatives in the treatment of oropharynx squamous cell carcinomas (OPSCC) and has become increasingly accepted by surgeons as a treatment option. Surgical robots were designed for various purposes, such as allowing remote telesurgery, and eliminating human factors like trembling. The study aimed to compare systematic review of the available literature in order to evaluate the safety and efficacy of Transoral Robotic Surgery (TORS) compared with open surgery.
The Role of Robotic Surgery in Laryngeal Cancer. [2023]Transoral robotic surgery (TORS) is a growing field in the treatment of head and neck cancers. Its benefits have been proven in the treatment of oropharynx HPV-positive squamous cell carcinoma, replacing chemoradiation as primary treatment of early-stage cancers or reducing the required radiation dosage, leading to improved functional outcomes without compromising oncological outcomes. There is also interest in the application of TORS for larynx cancer with the hope of achieving similar outcomes to replace open surgery or radiation treatments. Specifically, in the larynx, TORS can be used to resect supraglottic or glottic tumors.
Transoral Robotic Surgery: Step-by-Step Radical Tonsillectomy. [2021]Introduction. Transoral robotic surgery (TORS) radical tonsillectomy is an emerging minimally invasive surgical procedure for the treatment of cancer of the tonsil. The detailed surgical technique and claims for its reproducibility have been previously published. Case Presentation. We present a patient with a T2N2bM0 epidermoid carcinoma of the tonsil to illustrate step by step the surgical procedure for TORS radical tonsillectomy. Neck dissection and TORS were staged. No surgical reconstruction of the defect was required. No tracheostomy was necessary. The patient could eat without any feeding tube and was on full oral diet on the fifth postoperative day. Discussion. The transoral approach offers the benefits of minimally invasive surgery to patients with cancer of the tonsil. The excellent exposure and high precision provided by robotic instrumentation allow the surgeon to closely follow and accomplish the surgical steps, which is the best warranty for safety and effectiveness.
Robotic-assisted oropharyngeal reconstruction. [2022]The development of robotic surgery has brought new levels of precision and control to minimally invasive surgical techniques. Its effectiveness, well established in urologic and gynecologic surgery applications, has also been demonstrated in cardiac, endocrine and general surgery. Recently, trans-oral robotic approaches to oropharyngeal tumor resection have been reported and, by eliminating the need for morbid lip and mandible splitting approaches, trans-oral robotic surgery (TORS) has allowed a re-assessment of surgical options for early stage tumors which have until recently been treated primarily with chemoradiation. The application of the TORS approach to malignant and non-malignant conditions affecting the oropharynx has created the need to develop robotic-assisted methods of managing the resultant tissue defects and to assess and compare the effectiveness of these procedures. This report details our early experience with the use of robotic surgery for management of soft tissue defects of the oropharynx in 12 patients.
Long-term Functional and Quality-of-Life Outcomes After Transoral Robotic Surgery in Patients With Oropharyngeal Cancer. [2022]In recent years, transoral robotic surgery (TORS) has emerged as a useful treatment for oropharyngeal squamous cell carcinoma (OPSCC). In appropriately selected patients, the use of TORS may allow avoidance of adjuvant chemotherapy and/or radiotherapy, thereby avoiding the long-term adverse effects of these therapies.