Adjuvant Radiation Therapy for Oropharynx Cancers

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Oropharynx Cancers+1 More
Adjuvant Radiation Therapy - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is for patients with cancer of the oropharynx caused by HPV. The treatment being studied is less intense radiation given over two weeks compared to the traditional six weeks of daily radiation therapy.

Eligible Conditions
  • Oropharynx Cancers

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 2 years

1 year
Quality of Life
2 years
Adverse Events Rate
Disease-free survival
Distant failure associated with DART vs standard treatment
Local/regional control
Overall Survival

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Single Arm Phase 2
67%Dysgeusia
65%Dermatitits radiation
55%Dry Mouth
47%Salivary duct inflammation
43%Fatigue
38%Dysphagia
33%Lymphedema
32%Anorexia
30%Alopecia
30%Mucositis oral
30%Voice alteration
20%Esophageal pain
18%Mucosal infection
18%Superficial soft tissue fibrosis
13%Dermatitis radiation
12%Sore throat
7%Aspiration
7%Neck edema
7%Hypothyroidism
5%Dehydration
5%Hoarseness
5%Other Gastrointestinal disorders
5%Nausea
5%Weight loss
3%Laryngeal edema
3%Pain
3%Depression
3%Edema face
3%Trismus
3%Other Musculoskeletal and connective tissue disorder
3%Oral pain
2%Constipation
2%Hypoxia
2%Anxiety
2%Lip pain
2%Dizziness
2%Other Ear and labyrinth disorders
2%Other General disorders and administration site conditions
2%Other Nervous system disorders
2%Vomiting
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT02159703) in the Single Arm Phase 2 ARM group. Side effects include: Dysgeusia with 67%, Dermatitits radiation with 65%, Dry Mouth with 55%, Salivary duct inflammation with 47%, Fatigue with 43%.

Trial Design

2 Treatment Groups

Standard of Care Treatment
1 of 2
De-escalated Adjuvant Radiation Therapy
1 of 2

Active Control

Experimental Treatment

227 Total Participants · 2 Treatment Groups

Primary Treatment: Adjuvant Radiation Therapy · No Placebo Group · Phase 3

De-escalated Adjuvant Radiation TherapyExperimental Group · 2 Interventions: Adjuvant Radiation Therapy, Docetaxel · Intervention Types: Radiation, Drug
Standard of Care TreatmentActiveComparator Group · 2 Interventions: Adjuvant Radiation Therapy, Cisplatin · Intervention Types: Radiation, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Adjuvant Radiation Therapy
2014
Completed Phase 2
~60
Docetaxel
FDA approved

Trial Logistics

Trial Timeline

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

Who is running the clinical trial?

Mayo ClinicLead Sponsor
2,893 Previous Clinical Trials
3,698,470 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Absence of distant metastases on standard diagnostic work-up ≤ 10 weeks prior to registration.
Lymph node > 3 cm.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 15th, 2021

Last Reviewed: November 22nd, 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.