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Alkylating agents

Reduced Radiation + Cisplatin for Oropharyngeal Cancer (EVADER Trial)

Phase 2
Waitlist Available
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must be ≥ 18 years of age
Patients with pathologically proven diagnosis of HPV-related OPSCC
Must not have
Patients with an unknown primary.
Previous chemotherapy or radiotherapy treatment for head and neck cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Summary

This trial is testing whether it's safe to omit radiotherapy to some lymph node areas to decrease side effects.

Who is the study for?
This trial is for adults with low-risk HPV-related oropharyngeal squamous cell carcinoma who haven't had chemo or radiotherapy for head and neck cancer. They must be fit enough for treatment, able to follow up, use effective contraception, and complete questionnaires in English or French.
What is being tested?
The study tests if omitting radiotherapy from certain lymph node areas in patients with specific oral cancers can reduce side effects without increasing the risk of cancer returning. It involves radiation and Cisplatin as treatments.
What are the potential side effects?
Potential side effects include those commonly associated with radiation therapy such as skin irritation, fatigue, dry mouth, difficulty swallowing, and nausea; plus Cisplatin's risks like kidney damage, hearing loss, nerve problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My throat cancer is caused by HPV.
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I've had specific scans of my head, neck, and body within the last 8 weeks.
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I am eligible for targeted radiation or combined radiation and chemotherapy.
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I am able to care for myself and perform daily activities.
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My cancer is in an early to mid-stage and hasn't spread far.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer's origin is unknown.
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I have had chemotherapy or radiotherapy for head and neck cancer.

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
Event-free Survival
Secondary study objectives
Distant Metastasis-Free Survival
Local control
Locoregional control
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Two Treatment OptionsExperimental Treatment2 Interventions
Option #1 - Radiotherapy 35 fractions, 5/wk, 7 wks 70Gy/56Gy Cisplatin 100mg/m2 on day 1, 22 and 43 or 40mg mg/m2/wk for 7 wks Option #2 - Radiation only-35 fraction, 6/wk, 6wks 70Gy/56Gy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation
2003
Completed Phase 2
~780
Cisplatin
2013
Completed Phase 3
~2360

Find a Location

Who is running the clinical trial?

Canadian Cancer Trials GroupLead Sponsor
127 Previous Clinical Trials
68,171 Total Patients Enrolled
Scott BratmanStudy ChairPrincess Margaret Cancer Centre, Toronto, ON
2 Previous Clinical Trials
53 Total Patients Enrolled

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03822897 — Phase 2
Oropharyngeal Cancer Research Study Groups: Two Treatment Options
Oropharyngeal Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT03822897 — Phase 2
Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03822897 — Phase 2
~17 spots leftby Sep 2025
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