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Radiotherapy for Human Papillomavirus

N/A
Waitlist Available
Led By Raymond Chai, MD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Summary

This trial is designed to reduce the number of patients who receive radiotherapy by only giving it to those who have a high risk of cancer returning.

Eligible Conditions
  • Human Papillomavirus
  • Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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
Disease Specific Survival (DSS)
Number of Participants With Locoregional Failures (LRFs)
Number of Participants With Progression-Free Survival (PFS)
Secondary study objectives
Global Quality of Life Scores
Number of Serious Adverse Events
Overall Survival

Side effects data

From 2016 Phase 3 trial • 854 Patients • NCT00003389
98%
Anemia
93%
Leukocytes decreased
90%
Lymphopenia
84%
Neutrophils decreased
78%
Neuropathy-sensory
75%
Alopecia
74%
Fatigue
67%
Nausea
60%
Hyperglycemia
52%
Constipation
46%
Hypoalbuminemia
40%
Myalgia
34%
Stomatitis
33%
Insomnia
32%
Vomiting
27%
Platelets decreased
26%
Alkaline phosphatase increased
26%
Aspartate aminotransferase increased
23%
Dyspnea
20%
Dyspepsia
19%
Dysphagia
19%
Headache
16%
Anorexia
16%
Arthralgia
15%
Neuropathy-motor
15%
Abdominal pain
14%
Infection w/o neutropenia
14%
Cough
14%
Fever
13%
Rash/desquamation
13%
Diarrhea w/o prior colostomy
12%
Bone pain
11%
Weight gain
11%
Taste disturbance
11%
Anxiety/agitation
10%
Sweating
10%
Radiation dermatitis
9%
Rigors/chills
9%
Dizziness/lightheadedness
9%
Injection site reaction
8%
Dysphagia-esophageal radiation
8%
Hypoglycemia
8%
Blood bilirubin increased
8%
Chest pain
8%
Pain-other
8%
Phlebitis
7%
Creatinine increased
7%
Edema
7%
Pruritus
6%
Hot flashes
6%
Infection w/ grade 3 or 4 neutropenia
6%
Weight loss
5%
Muscle weakness
5%
Depression
5%
Mouth dryness
4%
Transfusion: pRBCs
4%
Pneumonitis/pulmonary infiltrates
3%
Thrombosis/embolism
3%
Febrile neutropenia
3%
Irregular menses
3%
Nail changes
2%
Allergic rhinitis
1%
Allergic reaction
1%
Infection w/ unknown ANC
1%
Syncope
1%
Sinus tachycardia
1%
Dehydration
1%
Neuropathic pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Stanford V)
Arm A (ABVD)

Trial Design

4Treatment groups
Experimental Treatment
Group I: Low Risk Group IExperimental Treatment1 Intervention
Group I: * Complete resection (margins: tonsil \>1mm, tongue \>3mm, pT1-2, pN0-2B), * No LVI, no PNI, \<3 positive nodes. * No ECS, No matted or Level \>III,
Group II: Intermediate Risk Group IIExperimental Treatment2 Interventions
Group II * Complete resection (margins: tonsil \<1mm, tongue \<1mm, pT1-2, pN0-2B), * +LVI, +PNI, \<3 positive nodes. ≤1mm ECS.
Group III: High Risk Group IIIBExperimental Treatment2 Interventions
* Incomplete surgical resection with + surgical margins * ≥ 1 mm ECS * Matted nodes
Group IV: High Risk Group IIIAExperimental Treatment2 Interventions
* 3+ nodes, no ECS \> 1mm * Contralateral or supraclavicular nodes
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Concurrent Chemoradiation
2014
N/A
~120
Radiotherapy
2017
Completed Phase 3
~2610
PET/CT
2022
Completed Phase 3
~1300

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
886 Previous Clinical Trials
534,931 Total Patients Enrolled
Marshall Posner, MDStudy DirectorIcahn School of Medicine at Mount Sinai
6 Previous Clinical Trials
641 Total Patients Enrolled
Raymond Chai, MD4.948 ReviewsPrincipal Investigator - Icahn School of Medicine at Mount Sinai
Mount Sinai Beth Israel - Petrie Division
Medical School - University of Pittsburgh, Doctor of Medicine
University of Pittsburgh Medical Center, Residency in Otolaryngology
5Patient Review
The doctor is excellent, but I was unfortunately treated rudely by the staff.
~10 spots leftby Sep 2025
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