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Robotic Surgery + Radiation Therapy for Throat Cancer

Phase 2
Recruiting
Led By Raymond Chai
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Less than or equal to 20 pack year tobacco history with no active tobacco use
No previous surgery, radiation therapy, or chemotherapy for head and neck cancer
Must not have
Advanced nodal stage (AJCC 7th edition N2C, N3) or surgically unresectable disease or disease that cannot be fully resected, unequivocal radiographic extranodal extension, supraclavicular or matted metastatic disease, >3 radiographic pathologic cervical nodes
Autoimmune disease treated with chemotherapy agents or anti TNF agents within the last 2 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new treatment for HPV-related throat cancer. The hope is that it will be just as effective as the current standard of care but with fewer long-term side effects.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects include those related to surgery such as pain and bleeding, plus the typical effects of chemotherapy like nausea, fatigue, hair loss; reduced dose radiation may also cause skin irritation and sore throat.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have smoked 20 or fewer pack-years and I don't smoke now.
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I have not had surgery, radiation, or chemo for head/neck cancer.
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My cancer is in an early or intermediate stage without spread to distant areas.
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I am older than 18 years.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My throat cancer is linked to HPV and tested positive for p16.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread to many neck nodes or cannot be fully removed by surgery.
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I have been treated for an autoimmune disease with specific drugs in the past 2 years.
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My final pathology report shows 5 or more positive nodes.
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My throat cancer is not linked to HPV.
Select...
My initial tests show I have a low-risk HPV type.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Local and/or regional disease recurrence (LRR)
Secondary study objectives
Disease free survival (DFS)
European Organization of Research and Treatment Of Cancer (EORTC QLQ-C30)
European Organization of Research and Treatment of Head and Neck cancer questionnaire (EORTC QLQ-H&N35)
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Robotic surgery
2013
N/A
~550

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
904 Previous Clinical Trials
541,722 Total Patients Enrolled
Raymond ChaiPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

Media Library

Robotic surgery Clinical Trial Eligibility Overview. Trial Name: NCT05419089 — Phase 2
Oropharyngeal Carcinoma Research Study Groups: Robotic surgery only
Oropharyngeal Carcinoma Clinical Trial 2023: Robotic surgery Highlights & Side Effects. Trial Name: NCT05419089 — Phase 2
Robotic surgery 2023 Treatment Timeline for Medical Study. Trial Name: NCT05419089 — Phase 2
~43 spots leftby Jun 2027
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