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Alkylating agents

IMRT +/− Cisplatin for Oropharyngeal Cancer

Phase 2
Waitlist Available
Led By Sue Yom
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18
p16 positive by immunohistochemistry confirmed by central pathology review
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year post-rt. radiation therapy (rt) ends at approximately 6 weeks for arm 1 and 5 weeks for arm 2
Awards & highlights

Study Summary

This trial is studying IMRT with or without cisplatin to see how well it works in treating patients with oropharyngeal cancer.

Who is the study for?
This trial is for adults with advanced oropharyngeal cancer, which includes cancers of the mouth and throat. Participants must have a specific type of squamous cell carcinoma confirmed by pathology, measurable disease, and positive p16 immunohistochemistry. They should be in good physical condition (Zubrod Performance Status 0-1), not exceed a 10 pack-year smoking history, and have proper organ function. HIV-positive patients can join if they meet certain health criteria.Check my eligibility
What is being tested?
The study is testing whether reduced-dose intensity-modulated radiation therapy (IMRT) alone or combined with cisplatin chemotherapy is effective in treating advanced oropharyngeal cancer. Patients will be randomly assigned to receive either IMRT for 5 or 6 weeks with or without cisplatin to compare treatment outcomes.See study design
What are the potential side effects?
Potential side effects include those common to radiation therapy such as skin irritation, fatigue, dry mouth, difficulty swallowing, and loss of appetite. Cisplatin may cause additional effects like nausea, kidney damage, hearing loss, nerve problems and an increased risk of infection.

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 cancer is p16 positive.
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I have been diagnosed with squamous cell carcinoma in my throat.
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My cancer is in an early to mid-stage, not spread widely.
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My cancer tissue has been tested for p16.
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My cancer can be seen or measured on scans.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year post-rt. radiation therapy (rt) ends at approximately 6 weeks for arm 1 and 5 weeks for arm 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year post-rt. radiation therapy (rt) ends at approximately 6 weeks for arm 1 and 5 weeks for arm 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Alive Without Progression at Two Years (Progression-free Survival)
Secondary outcome measures
HPV DNA Copy Number
HPV DNA Rate Decline
Human Papillomavirus (HPV) Deoxyribonucleic Acid (DNA) Detection Rate
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: IMRT 6 weeks + cisplatinExperimental Treatment2 Interventions
IMRT 6 weeks with concurrent cisplatin
Group II: IMRT 5 weeksExperimental Treatment1 Intervention
IMRT 5 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,330 Total Patients Enrolled
NRG OncologyLead Sponsor
231 Previous Clinical Trials
100,508 Total Patients Enrolled
Sue YomPrincipal InvestigatorNRG Oncology

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02254278 — Phase 2
Tongue Cancer Research Study Groups: IMRT 5 weeks, IMRT 6 weeks + cisplatin
Tongue Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT02254278 — Phase 2
Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02254278 — Phase 2

Frequently Asked Questions

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

What are some of the primary illnesses that Cisplatin is used to treat?

"Cisplatin is a go-to treatment for advanced ovarian cancer. However, it has also shown efficacy in treating refractory testicular cancer and other directives."

Answered by AI

Are there many places in town where this clinical trial is happening?

"There are currently 100 patients enrolled in this clinical trial, with locations such as University Health Network-Princess Margaret Hospital in Toronto, UPMC-Heritage Valley Health System Beaver in Beaver, and NorthShore University HealthSystem-Glenbrook Hospital."

Answered by AI

Are there short-term or long-term risks associated with Cisplatin?

"Cisplatin safety is estimated to be a 2. Although there is some clinical data supporting its safety, none of it points to the medication being effective."

Answered by AI

How many people are allowed to enroll in this trial?

"This specific trial is not currently looking for new patients, as it was last edited on September 7th, 2022. However, there are 2798 other trials actively enrolling participants with stage ivb oropharyngeal squamous cell carcinoma and 714 trials for Cisplatin that are still recruiting."

Answered by AI

Are patients able to sign up for this clinical trial at this time?

"This study is no longer recruiting patients. The last date for recruitment was September 7th, 2022. However, there are 2798 other trials actively recruiting participants with stage ivb oropharyngeal squamous cell carcinoma and 714 trials for Cisplatin that may be of interest."

Answered by AI

Is this the first time Cisplatin has been used in a research setting?

"There are over seven-hundred clinical trials currently underway researching Cisplatin. Just under three-hundred of these live trials are in Phase 3. The majority of studies for Cisplatin are based in Shanghai, but there are 43259 locations running trials for this treatment globally."

Answered by AI
~30 spots leftby Mar 2025