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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~3120