Arm S (Low Risk) for Oropharynx Cancers

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
UPMC Hillman Cancer Center, Pittsburgh, PA
Oropharynx Cancers+1 More
therapeutic conventional surgery - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a trial studying patients with human papilloma virus (HPV) positive oropharyngeal cancer with tumors that can be removed via transoral surgery. Following surgery, patients will be classified as either low, intermediate, or high risk based on the characteristics of the tumors. Low risk patients (Arm S) will receive no further treatment after surgery. Intermediate risk patients (Arm RT) will be treated with Intensity Modulated Radiotherapy (IMRT) after surgery. High risk patients (Arm CRT) will receive a combination of IMRT and chemotherapy after surgery. Patients will be followed for up to five years after the completion of treatment.

Eligible Conditions

  • Oropharynx Cancers

Treatment Effectiveness

Study Objectives

1 Primary · 15 Secondary · Reporting Duration: Baseline (before treatment), at 4-6 weeks post-surgery, at 1 year, up to 2 years following treatment

Year 1
Assessment of PEG tube dependence
Year 2
MD Anderson Dysphagia Inventory (MDADI)
Voice outcomes
Year 2
Performance Status Scale (PSS-HN)
Quality of Life via FACT-HN
Year 2
MD Anderson Symptom Inventory-Head & Neck (MDASI-HN)
Month 24
Modified Barium Swallow (MBS) rating
Up to 1 year
Loco-regional control (at 1 year)
Overall survival at 1 year
Time to distant metastasis (at 1 year)
Up to 2 year
Loco-regional control (at 2 years)
Up to 2 years
Overall survival at 2 years
Time to distant metastasis (at 2 years)
Year 2
Recurrence-Free Survival (RFS)
Up to 3 years
Distribution of patients based on histologic risk features
Up to 5 years
Adverse Events Related to Treatment

Trial Safety

Safety Progress

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

Trial Design

3 Treatment Groups

Arm S (Low Risk)
1 of 3
Arm CRT (High Risk)
1 of 3
Arm RT (Intermediate Risk)
1 of 3
Experimental Treatment

150 Total Participants · 3 Treatment Groups

Primary Treatment: Arm S (Low Risk) · No Placebo Group · Phase 2

Arm S (Low Risk)Experimental Group · 3 Interventions: therapeutic conventional surgery, laboratory biomarker analysis, quality-of-life assessment · Intervention Types: Procedure, Other, Other
Arm CRT (High Risk)Experimental Group · 6 Interventions: therapeutic conventional surgery, laboratory biomarker analysis, Carboplatin, quality-of-life assessment, Cisplatin, intensity-modulated radiation therapy · Intervention Types: Procedure, Other, Drug, Other, Drug, Radiation
Arm RT (Intermediate Risk)Experimental Group · 4 Interventions: therapeutic conventional surgery, laboratory biomarker analysis, quality-of-life assessment, intensity-modulated radiation therapy · Intervention Types: Procedure, Other, Other, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
therapeutic conventional surgery
2003
Completed Phase 3
~11930
Carboplatin
2014
Completed Phase 3
~6570
Cisplatin
2013
Completed Phase 3
~3340
intensity-modulated radiation therapy
2008
Completed Phase 3
~1500

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (before treatment), at 4-6 weeks post-surgery, at 1 year, up to 2 years following treatment
Closest Location: UPMC Hillman Cancer Center · Pittsburgh, PA
Photo of UPMC Hillman Cancer Center  1Photo of UPMC Hillman Cancer Center  2Photo of UPMC Hillman Cancer Center  3
2007First Recorded Clinical Trial
1 TrialsResearching Oropharynx Cancers
63 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have no symptoms or signs of cancer.
You have a histologically or cytologically confirmed oropharyngeal cancer.
You have a primary tumor that is staged as III, IV a, or IV b, with no evidence of distant metastases
p16 protein expression using immunohistochemistry (IHC) performed by a CLIA approved laboratory.
You have a kidney or liver function that is acceptable within 4 weeks prior to registration as predefined.

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.