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Monoclonal Antibodies

SBRT + Cetuximab + Docetaxel followed by Cetuximab + Docetaxel for Head and Neck Cancers

Phase 2

Waitlist Available

Led By Dwight E Heron, MD

Research Sponsored by Heath Skinner

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 will compare the overall survival of patients treated with SBRT and cetuximab alone to the overall survival of patients with the addition of docetaxel.

Eligible Conditions

Previously-Irradiated
Head and Neck Cancers

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

1-Year Locoregional Progression-free survival (PFS)

Acute toxicities

Incidence of distant disease

+1 more

Secondary outcome measures

Objective Response Rate (ORR)

Overall Survival (OS)

Progression-free Survival (PFS)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: SBRT + Cetuximab followed by CetuximabExperimental Treatment2 Interventions

Previously Treated with Cetuximab - Group B; No Previous Cetuximab - Group D

Group II: SBRT + Cetuximab + Docetaxel followed by Cetuximab + DocetaxelExperimental Treatment3 Interventions

Previously Treated With Cetuximab - Group A; No Previous Cetuximab - Group C

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Docetaxel

FDA approved

SBRT

2014

Completed Phase 2

~1060

Cetuximab

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Heath SkinnerLead Sponsor

3 Previous Clinical Trials

286 Total Patients Enrolled

David A. Clump, MD, PhDLead Sponsor

9 Previous Clinical Trials

316 Total Patients Enrolled

Dwight E Heron, MDPrincipal InvestigatorUniversity of Pittsburgh

3 Previous Clinical Trials

169 Total Patients Enrolled

Frequently Asked Questions

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

What indication does this treatment usually target?

"This proposed treatment is for patients suffering from malignant neoplasms, sarcoma, and squamous cell carcinoma."

Answered by AI

Are there any other similar treatments that have been looked at in clinical trials?

"There are currently 465 different clinical trials researching this treatment, with 159 of them in Phase 3. Many studies for this treatment are located in Pittsburgh, Pennsylvania; however, there are 28279 total locations operating trials for this treatment."

Answered by AI

What is the total sample size for this clinical trial?

"That is accurate. The listing on clinicaltrials.gov indicates that this study, which was established on May 1st 2013, is still recruiting patients. A total of 92 people are needed for the research being conducted at a single location."

Answered by AI

Has this particular drug been greenlit by the FDA?

"This treatment received a safety score of 2 because, although Phase 2 trials provide some evidence that the intervention is safe, there is no data indicating that it is effective."

Answered by AI

Are there still available positions for participants in this research?

"Correct, the clinical trial is still looking for 92 participants and is being hosted at 1 location. The listing on clinicaltrials.gov has not been updated since 8/26/2020 but the study was originally posted on 5/1/2013."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

SBRT With Cetuximab +/- Docetaxel Followed by Adjuvant Cetuximab +/- Docetaxel in Recurrent, Previously-Irradiated SCCHN

Heath Skinner 2013. "SBRT With Cetuximab +/- Docetaxel Followed by Adjuvant Cetuximab +/- Docetaxel in Recurrent, Previously-Irradiated SCCHN". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02057107.