Radiotherapy vs. Surgery for Throat Cancer
Recruiting in Palo Alto (17 mi)
Overseen byDanielle MacNeil, M.D.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
Disqualifiers: Serious comorbidities, Prior head/neck cancer, Metastatic disease, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?The goal of this randomized phase II study is a formal comparison of radiotherapy versus trans-oral surgery as the primary treatment of HPV-negative patients with early-stage oropharyngeal carcinoma.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What data supports the effectiveness of the treatment for throat cancer?
Research shows that Transoral Robotic Surgery (TORS) is effective for early-stage oropharyngeal cancer, achieving successful outcomes in 97% of patients in one study. TORS also offers better functional recovery and quality of life compared to more invasive surgeries.
12345Is transoral robotic surgery (TORS) safe for treating throat cancer?
Transoral robotic surgery (TORS) is considered a safe treatment for oropharyngeal squamous cell carcinoma (OPSCC), with studies showing it is feasible and has been approved by the FDA for this use. It is often preferred due to assumptions of fewer side effects and better quality of life compared to traditional radiotherapy.
34678How does the treatment of Radiotherapy vs. Surgery for Throat Cancer differ from other treatments?
This treatment is unique because it compares traditional radiotherapy, which preserves the throat's structure, with Transoral Robotic Surgery (TORS), a minimally invasive surgery that can offer better functional recovery and quality of life for early-stage throat cancer patients.
245910Eligibility Criteria
This trial is for adults over 18 with HPV-negative oropharyngeal squamous cell carcinoma, which includes cancers in the tonsils and base of tongue. Participants must be fit enough for surgery or radiotherapy, have no distant cancer spread, and not be pregnant. They should also have adequate organ function and agree to attend all treatments and follow-ups.Inclusion Criteria
My tumor is HPV-negative.
I am 18 years old or older.
My recent blood tests show my liver, kidneys, and bone marrow are working well.
+8 more
Exclusion Criteria
I had head or neck cancer in the last 5 years.
I cannot attend all radiotherapy sessions or follow-up visits.
I cannot or do not want to fill out quality of life questionnaires.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants are randomized to receive either standard treatment with radiation +/- chemotherapy or trans-oral surgery with neck dissection
6-8 weeks
Follow-up
Participants are monitored for safety, effectiveness, and quality of life outcomes
5 years
Participant Groups
The study compares two primary treatments: radiation therapy versus trans-oral surgery followed by neck dissection in patients with early-stage HPV-negative oropharyngeal cancer. It's a phase II trial where participants are randomly assigned to one of these treatment options.
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2, TOS + Neck DissectionExperimental Treatment1 Intervention
Trans-oral Surgery (TOS) + Neck Dissection (plus radiation is required)
Group II: Arm 1, Radiation +/- ChemotherapyActive Control1 Intervention
Standard Treatment (Radiation +/- Chemotherapy)
Radiation is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as Radiation Therapy for:
- Cancer treatment
- HPV-positive throat cancer
- Various types of tumors
🇺🇸 Approved in United States as Radiation Therapy for:
- Cancer treatment
- HPV-positive throat cancer
- Various types of tumors
🇨🇦 Approved in Canada as Radiation Therapy for:
- Cancer treatment
- HPV-positive throat cancer
- Various types of tumors
🇯🇵 Approved in Japan as Radiation Therapy for:
- Cancer treatment
- HPV-positive throat cancer
- Various types of tumors
🇨🇳 Approved in China as Radiation Therapy for:
- Cancer treatment
- HPV-positive throat cancer
- Various types of tumors
🇨🇭 Approved in Switzerland as Radiation Therapy for:
- Cancer treatment
- HPV-positive throat cancer
- Various types of tumors
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
London Regional Cancer ProgramLondon, Canada
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Who Is Running the Clinical Trial?
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph'sLead Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sLead Sponsor
London Health Sciences Centre OR Lawson Research Institute of St. Joseph'sLead Sponsor
Lawson Health Research InstituteLead Sponsor
References
Transoral robotic surgery: The radiation oncologist's perspective. [2018]Transoral Robotic Surgery (TORS) is a fascinating new technology allowing for excellent functional outcomes after resection of head and neck tumors that previously required morbid surgical approaches for access. With a new technology, however, come new questions as to optimal patient selection and its impact on adjuvant therapy considerations. Here we review the issues most pertinent to a radiation oncologist adapting to the use of TORS. Patient selection, indications for adjuvant radiotherapy, radiation dose and target volumes are discussed. Finally, ongoing clinical trials and future directions are considered.
Comparison study of transoral robotic surgery and radical open surgery for hypopharyngeal cancer. [2014]The oncologic outcome of transoral robotic surgery (TORS) was comparable to radical open surgery. The TORS group showed a better functional recovery and quality of life (QOL) than the radical surgery group. Therefore, TORS was a valid treatment option as a minimally invasive surgery for selected patients with hypopharyngeal cancer.
Modern treatment outcomes for early T-stage oropharyngeal cancer treated with intensity-modulated radiation therapy at a tertiary care institution. [2021]Transoral surgery (TOS), particularly transoral robotic surgery (TORS) has become the preferred modality in the United States for the treatment of early stage oropharyngeal cancer, largely due to assumptions of fewer toxicities and improved quality of life compared to primary radiotherapy (RT). However, these assumptions are based on retrospective analysis, a subset of which utilize primary RT groups not limited to T1-2 stage tumors for which transoral robotic surgery is FDA approved. Thus, there is potential for underestimating survival and overestimating toxicity, including treatment related mortality, in primary RT.
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.
Oncologic, functional and surgical outcomes of primary Transoral Robotic Surgery for early squamous cell cancer of the oropharynx: a systematic review. [2023]Transoral Robotic Surgery (TORS) has emerged as an alternative to radiotherapy or chemoradiotherapy for the treatment of oropharyngeal squamous cell carcinoma (OPSCC). Many centers restrict the use of TORS to early (T1-2) OPSCC. The purpose of this article was to assess oncologic and functional outcomes of TORS for primary treatment of early OPSCC.
Decision management in transoral robotic surgery: Indications, individual patient selection, and role in the multidisciplinary treatment for head and neck cancer from a European perspective. [2022]Transoral robotic surgery (TORS) has become an accepted first-line treatment for T1 and T2 head and neck squamous cell carcinoma (HNSCC). The growing popularity of this procedure is the result of mounting skepticism as to the survival and quality of life (QOL) benefits of primary chemoradiation over definitive surgery, the rising incidence of human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma (OPSCC) in progressively younger patients, and the advantages of TORS over transoral laser microsurgery (TOLM) and open surgery.
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.
Trans oral robotic surgery for oropharyngeal cancer: A multi institutional experience. [2023]Trans Oral Robotic Surgery (TORS) has proved to be a safe and feasible treatment for oropharyngeal squamous cell carcinoma (OPSCC). The aim of this study is to analyse oncological outcomes of OPSCC patients treated with TORS.
Primary surgery versus (chemo)radiotherapy in oropharyngeal cancer: the radiation oncologist's and medical oncologist's perspectives. [2015]Radiotherapy is the traditional treatment for oropharyngeal cancer (OPC) because of its ability to preserve anatomic form and function compared with other conventional curative options. Recently, transoral robotic surgery (TORS) and transoral laser microsurgery (TLM) have emerged prominently for T1-T2 OPC. This review summarizes the recent literature pertaining to OPC outcomes following primary TORS/TLM versus primary radiotherapy with or without chemotherapy and addresses controversies surrounding indications for adjuvant treatment following TORS/TLM.
Economic evaluations comparing Tran-oral robotic surgery and radiotherapy in oropharyngeal squamous cell carcinoma: A systematic review. [2022]Trans-oral robotic surgery (TORS) and primary radiotherapy are the two modalities used to treat early T stage oropharyngeal squamous cell carcinoma(OPSCC). Prior literature including a recent randomized controlled trial have not shown the superiority of one modality over the other. When the modalities have similar outcomes, cost-effectiveness have an important role in deciding on the appropriate treatment. There are economic evaluations comparing the two modality with contradicting conclusions. The purpose of this review is to synthesise the evidence.