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Monoclonal Antibodies

Radiation Therapy for Oropharyngeal Cancer

Phase 2

Waitlist Available

Led By Robert K Chin

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing radiation and cisplatin with or without cetuximab to treat patients with HPV-positive oropharyngeal squamous cell carcinoma that has spread.

Eligible Conditions

Oropharyngeal Cancer
KRAS Protein Variant
Oropharyngeal Carcinoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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

Overall survival (OS)

Secondary outcome measures

Acute toxicity

Late toxicity

Locoregional recurrence rate

+1 more

Other outcome measures

Body Weight Changes

Germline mutation prediction rate

Nonsynonymous mutational load and intratumoral heterogeneity clinical outcome predictions

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (cetuximab, radiation therapy, cisplatin)Experimental Treatment5 Interventions

Patients receive cetuximab IV over 120 minutes 5-7 days prior to start of radiation therapy and then IV over 60 minutes weekly on Monday or Tuesday for 7 weeks. Patients also undergo radiation therapy and receive cisplatin as in Arm I.

Group II: Arm I (radiation therapy, cisplatin)Active Control4 Interventions

Beginning on day 0, patients undergo radiation therapy over 6 weeks for a total of 35 fractions. Patients also receive cisplatin IV over 1-2 hours on days 0 and 21.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cetuximab

FDA approved

Chloride ion

Not yet FDA approved

Radiation Therapy

2017

Completed Phase 3

~7250

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyIndustry Sponsor

2,624 Previous Clinical Trials

3,216,796 Total Patients Enrolled

Jonsson Comprehensive Cancer CenterLead Sponsor

361 Previous Clinical Trials

27,747 Total Patients Enrolled

Robert K ChinPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center

Frequently Asked Questions

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

Can people with the required qualifications sign up for this research project right now?

"That is correct. The information available on clinicaltrials.gov reveals that this study is still looking for 70 individuals to take part in the trial, which was first posted on 1/14/2020."

Answered by AI

What are some common reasons why patients might undergo Radiation Therapy?

"malignant neoplasms located in the testes, head and neck squamous cell carcinoma, and certain epithelial ovarian tumours can all be treated with radiation."

Answered by AI

What other scientific research studies have utilized Radiation Therapy?

"At the moment, 888 ongoing studies are researching Radiation Therapy with 321 trials in Phase 3. While a few of the studies for Radiation Therapy are situated in Shanghai, there are 49092 locations conducting research on this topic."

Answered by AI

Does the FDA condone radiation as a treatment method?

"While there is some evidence to support the safety of Radiation Therapy, it received a score of 2 because Phase 2 trials have not yielded data in support of efficacy."

Answered by AI

How many study participants are there in total?

"That is correct, the online information from clinicaltrials.gov does state that this particular trial is still recruiting patients. This study was first posted on January 14th 2020, with the most recent update taking place on October 13th 2022. Only 70 individuals are needed for participation at 1 location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With HPV Positive, KRAS-Variant Stage III-IV Oropharyngeal Squamous Cell Carcinoma

2020. "Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With HPV Positive, KRAS-Variant Stage III-IV Oropharyngeal Squamous Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04106362.