Robotic surgery only for Carcinoma, Squamous Cell

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Mount Sinai Health System, New York, NY
Carcinoma, Squamous Cell+3 More
Robotic surgery - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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), either with transoral robotic surgery (TORS) alone or combined with reduced doses of radiation and chemotherapy can result in cancer control and survival comparable to those previously reported with standard therapy. The hope is that with this newer approach, the long-term complications from chemotherapy and radiation can be reduced.

Eligible Conditions

  • Carcinoma, Squamous Cell
  • HPV-positive Oropharyngeal Squamous Cell Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: 2 years

2 years
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)
Local and/or regional disease recurrence (LRR)
M.D. Anderson Dysphagia Inventory
M.D. Anderson Symptom Inventory - Head & Neck (MDASI-HN)
Overall Survival (OS)
Progression-free survival (PFS)
Xerostomia Questionnaire (XQ)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Robotic surgery only
1 of 2
Robotic surgery with de-intensified adjuvant therapy
1 of 2
Experimental Treatment

199 Total Participants · 2 Treatment Groups

Primary Treatment: Robotic surgery only · No Placebo Group · Phase 2

Robotic surgery only
Procedure
Experimental Group · 1 Intervention: Robotic surgery · Intervention Types: Procedure
Robotic surgery with de-intensified adjuvant therapyExperimental Group · 3 Interventions: Robotic surgery, Cisplatin, De-intensified XRT · Intervention Types: Procedure, Drug, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Robotic surgery
2013
N/A
~540
Cisplatin
2013
Completed Phase 3
~3340

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Trial Background

Prof. Raymond Chai, Associate Professor of Otolaryngology
Principal Investigator
Icahn School of Medicine at Mount Sinai
Closest Location: Mount Sinai Health System · New York, NY
Photo of New York  1Photo of New York  2Photo of New York  3
2018First Recorded Clinical Trial
1 TrialsResearching Carcinoma, Squamous Cell
9 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have detectable baseline HIV RNA.
You have early or intermediate stage prostate cancer without evidence of distant metastases or gross extranodal extension.
You have not had previous surgery, radiation therapy, or chemotherapy for head and neck cancer.
You have a performance status of 0 or 1.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.