← Back to Search

Monoclonal Antibodies

Radiation + Drug for Oropharyngeal Cancer

Phase 3

Waitlist Available

Led By Maura Gillison, MD, PhD

Research Sponsored by Radiation Therapy Oncology Group

Eligibility Criteria Checklist

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

Must have

Age ≥ 18

Patients who are HIV positive but have no prior AIDS-defining illness and have CD4 cells of at least 350/mm3 are eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to last follow-up. analysis was to occur after 180 deaths were reported. analysis occurred after 133 deaths were reported. maximum follow-up at time of analysis was 6.5 years.

Awards & highlights

Study Summary

This trial is comparing radiation therapy with cisplatin to radiation therapy with cetuximab to see which is more effective in treating oropharyngeal cancer.

Who is the study for?

Adults with oropharyngeal cancer, specifically squamous cell carcinoma, who haven't had prior chemotherapy or radiotherapy for it. They should have a good performance status and no severe health issues like recent heart attacks or uncontrolled infections. HIV-positive patients can join if they don't have AIDS-defining conditions.Check my eligibility

What is being tested?

This trial is testing whether radiation therapy combined with either cisplatin (a chemotherapy drug) or cetuximab (a monoclonal antibody that targets cancer cells) is more effective in treating patients with cancers of the throat area.See study design

What are the potential side effects?

Cisplatin may cause nausea, kidney damage, hearing loss, and nerve damage. Cetuximab can lead to skin reactions, low magnesium levels, and infusion-related reactions. Radiation therapy might result in skin irritation and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I am HIV positive with no AIDS-defining illness and my CD4 count is at least 350.

Select...

My cancer can be seen or measured on scans.

Select...

I have been diagnosed with squamous cell carcinoma in my throat.

Select...

My cancer is p16 positive, confirmed by a specialized test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to last follow-up. analysis was to occur after 180 deaths were reported. analysis occurred after 133 deaths were reported. maximum follow-up at time of analysis was 6.5 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to last follow-up. analysis was to occur after 180 deaths were reported. analysis occurred after 133 deaths were reported. maximum follow-up at time of analysis was 6.5 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to last follow-up. analysis was to occur after 180 deaths were reported. analysis occurred after 133 deaths were reported. maximum follow-up at time of analysis was 6.5 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

Secondary outcome measures

Behavioral Risk Assessment Survey (BRASS) at Baseline.

Distribution of First Progression Events

EORTC QLQ-C30 at Baseline, End of Treatment, 3, 6, and 12 Months From End of Treatment.

+24 more

Trial Design

2Treatment groups

Active Control

Group I: IMRT + CisplatinActive Control2 Interventions

Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin

Group II: IMRT + CetuximabActive Control2 Interventions

Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,166 Total Patients Enrolled

NRG OncologyOTHER

231 Previous Clinical Trials

99,865 Total Patients Enrolled

Radiation Therapy Oncology GroupLead Sponsor

190 Previous Clinical Trials

63,940 Total Patients Enrolled

Media Library

Cetuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT01302834 — Phase 3

Head and Neck Cancers Research Study Groups: IMRT + Cisplatin, IMRT + Cetuximab

Head and Neck Cancers Clinical Trial 2023: Cetuximab Highlights & Side Effects. Trial Name: NCT01302834 — Phase 3

Cetuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01302834 — Phase 3

Frequently Asked Questions

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

What other research has been undertaken that includes IMRT + Cisplatin?

"The original IMRT + Cisplatin study was conducted in 1997 at City of Hope Comprehensive Cancer Center. Since then, there have been 1233 completed clinical trials. There are currently 830 active clinical trials recruiting patients, many of which are located in Reading, Ohio."

Answered by AI

Does this research project welcome test subjects who are less than 75 years old?

"The age range for this study is 18 to 120. All patients that fall within this age bracket are eligible for enrollment."

Answered by AI

What are the government's thoughts on IMRT + Cisplatin?

"IMRT + Cisplatin is considered to be a safe medical intervention because it has received a score of 3. This means that there is both evidence of its efficacy and multiple rounds of data supporting its safety."

Answered by AI

How many people fit the requirements to join this trial?

"Unfortunately, this particular clinical trial is not looking for new patients at this time. The trial was first posted on 6/1/2011 and was most recently edited on 9/7/2022. However, there are 328 other clinical trials actively searching for participants with precancerous conditions and 830 studies for IMRT + Cisplatin actively enrolling patients."

Answered by AI

For what type of cancer is the IMRT + Cisplatin chemotherapy regimen most often prescribed?

"IMRT + Cisplatin is a common treatment for advanced testicular cancer, but can also be used to manage metastatic squamous cell carcinoma of the head and neck, advanced ovarian cancer, and squamous cell carcinoma."

Answered by AI

Could you please list how many hospitals are participating in this clinical trial?

"100 hospitals, including McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center in Reading, Northwest Ohio Oncology Center in Maumee, and Hillcrest Cancer Center at Hillcrest Hospital in Mayfield Heights, are currently operating for this trial."

Answered by AI

If I qualify, who can I expect to see in this research project?

"This clinical trial is looking for 987 patients with precancerous conditions. To be eligible, patients must be aged 18-120 and have a Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls). Additionally, patients must have a positive p16 test result and clinically or radiographically evident measurable disease. General history and physical examination by a radiation oncologist and medical oncologist within 8 weeks prior to registration is also required. Finally, applicants must have a CT scan of"

Answered by AI

Recent research and studies

The LancetJournal

Radiotherapy Plus Cetuximab or Cisplatin in Human Papillomavirus-positive Oropharyngeal Cancer (NRG Oncology RTOG 1016): A Randomised, Multicentre, Non-inferiority Trial

Gillison, Maura L, Andy M Trotti, Jonathan Harris, Avraham Eisbruch, Paul M Harari, David J Adelstein, Richard C K Jordan, et al.. 2019. “Radiotherapy Plus Cetuximab or Cisplatin in Human Papillomavirus-positive Oropharyngeal Cancer (NRG Oncology RTOG 1016): A Randomised, Multicentre, Non-inferiority Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(18)32779-x.

Annals of OncologyJournal

The Current and Future Impact of Human Papillomavirus on Treatment of Squamous Cell Carcinoma of the Head and Neck

Psyrri, A., T. Rampias, and J.B. Vermorken. 2014. “The Current and Future Impact of Human Papillomavirus on Treatment of Squamous Cell Carcinoma of the Head and Neck”. Annals of Oncology. Elsevier BV. doi:10.1093/annonc/mdu265.

clinicaltrials.govStudy

Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer

2011. "Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01302834.