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Robotic Surgery + Radiation Therapy for Throat Cancer

Q: Are new participants being inducted into this scientific experiment?

Affirmative. It is evident from the information published on clinicaltrials.gov that this medical study, which was initially advertised on July 12th 2022, is currently recruiting patients . The research necessitates 199 participants from 1 various sites to participate in it.

Q: Has De-intensified XRT been cleared by the government agency for use?

The safety of De-intensified XRT is rated moderately high, at a 2 on the scale. This assessment is based off of Phase 2 trial data indicating that there are some studies supporting its relative safety but none confirming efficacy.

Q: How many individuals are being enlisted for this clinical trial?

Affirmative. Clinicaltrials.gov records detail that this research is actively seeking out participants, with the original post taking place on July 12th 2022 and an update occurring on October 26th of the same year. 199 individuals must be enlisted from a single location for the trial to properly take place.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I have smoked 20 or fewer pack-years and I don't smoke now.

Select...

I have not had surgery, radiation, or chemo for head/neck cancer.

Select...

My cancer is in an early or intermediate stage without spread to distant areas.

Select...

I am older than 18 years.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Select...

My throat cancer is linked to HPV and tested positive for p16.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Local and/or regional disease recurrence (LRR)

Secondary outcome measures

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Robotic surgery with de-intensified adjuvant therapyExperimental Treatment3 Interventions

The presence of any of the following: 4 positive nodes, gross ENE, final positive margins, or bilateral neck disease High-risk PNI/LVI (defined as PNI and LVI in combination or either factor in the presence of 3 or more positive nodes)

Group II: 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

Cisplatin

2013

Completed Phase 3

~1940

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

860 Previous Clinical Trials

524,277 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 with de-intensified adjuvant therapy, 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being inducted into this scientific experiment?

"Affirmative. It is evident from the information published on clinicaltrials.gov that this medical study, which was initially advertised on July 12th 2022, is currently recruiting patients . The research necessitates 199 participants from 1 various sites to participate in it."

Answered by AI

Has De-intensified XRT been cleared by the government agency for use?

"The safety of De-intensified XRT is rated moderately high, at a 2 on the scale. This assessment is based off of Phase 2 trial data indicating that there are some studies supporting its relative safety but none confirming efficacy."

Answered by AI

How many individuals are being enlisted for this clinical trial?

"Affirmative. Clinicaltrials.gov records detail that this research is actively seeking out participants, with the original post taking place on July 12th 2022 and an update occurring on October 26th of the same year. 199 individuals must be enlisted from a single location for the trial to properly take place."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Raymond Chai 2022. "The Sinai Robotic Surgery Trial in HPV-related Oropharyngeal Squamous Cell Carcinoma (SIRS 2.0 Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05419089.