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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

EVADER Trial 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.Check my eligibility

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.See study design

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.

EVADER Trial 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.

EVADER Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Event-free Survival

Secondary outcome measures

Distant Metastasis-Free Survival

Local control

Locoregional control

+2 more

EVADER 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 3

~1020

Cisplatin

2013

Completed Phase 3

~1940

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Canadian Cancer Trials GroupLead Sponsor

124 Previous Clinical Trials

67,350 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Why is this medication often prescribed?

"This treatment is often used to treat advanced ovarian cancer. It can also be effective at treating other conditions such as advanced testicular cancer, refractory to standard therapies, and advance directives."

Answered by AI

How does this medication's safety compare to other treatments?

"While there is some evidence supporting the safety of this Phase 2 treatment, there is no clinical data yet to suggest that it is effective."

Answered by AI

Are there any available openings for test subjects in this experiment?

"As of right now, this trial is not looking for new participants. It was initially posted on February 20th, 2019 and was last updated on December 3rd, 2021. If you are interested in other studies, 856 studies for oral squamous cell carcinoma are currently admitting patients and 713 studies are actively recruiting patients for this treatment."

Answered by AI

Can you tell us about other research that has been conducted using this treatment method?

"City of Hope Comprehensive Cancer Center first studied this treatment back in 1997 and, to date, 981 trials have completed. Right now, 713 studies are active with a large proportion taking place in Vancouver, British Columbia."

Answered by AI

How many research participants are being enrolled in this study?

"This particular study is no longer looking for patients as of December 3rd, 2021. However, there are 856 other trials for oral squamous cell carcinoma and 713 studies for this treatment that are currently searching for patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

De-Escalation Radiotherapy in Patients With Low-Risk HPV-Related Oropharyngeal Squamous Cell Carcinoma

2019. "De-Escalation Radiotherapy in Patients With Low-Risk HPV-Related Oropharyngeal Squamous Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03822897.

All > Squamous Cell Carcinoma