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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
Lifetime cumulative smoking history of < 10 pack-years. The cumulative total of the number of pack-years during each period of active smoking is the lifetime cumulative history
Note: Investigators are discouraged from enrolling patients with a history of very sustained use (such as several years or more) of non-cigarette tobacco products alone given that the effect of non-cigarette tobacco products on the survival of patients with p16-positive oropharyngeal cancers is undefined
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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have smoked less than 10 packs of cigarettes in your entire life. A pack-year is a way to measure smoking history by multiplying the number of packs of cigarettes smoked per day by the number of years a person has smoked.
Select...
It is not recommended for individuals who have used non-cigarette tobacco products heavily for many years to participate in the study, as the impact of such products on the survival of patients with certain types of throat cancer is not known.

Timeline

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

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyIndustry Sponsor
2,605 Previous Clinical Trials
3,199,669 Total Patients Enrolled
Jonsson Comprehensive Cancer CenterLead Sponsor
358 Previous Clinical Trials
26,075 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
~0 spots leftby Mar 2025