Radiation Therapy for Cutaneous Squamous Cell Carcinoma of the Head and Neck

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of California Davis Comprehensive Cancer Center, Sacramento, CACutaneous Squamous Cell Carcinoma of the Head and Neck+2 MoreRadiation Therapy - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial tests whether atezolizumab can shrink tumors before surgery in patients with head and neck squamous cell cancer that has spread to the lymph nodes.

Eligible Conditions
  • Cutaneous Squamous Cell Carcinoma of the Head and Neck
  • Cutaneous Squamous Cell Carcinoma of the Head and Neck (Stage III)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Radiation Therapy
1
Stereotactic Body Radiation Therapy
1
Radiation Therapy

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Up to 3 years

Week 10
Major pathologic response (mPR)
Pathologic complete response (pCR)
Year 2
Event free survival (EFS)
Month 3
Fludeoxyglucose F-18 (FDG) avidity and response to neoadjuvant immunotherapy
Up to 3 years
Incidence of adverse events
Overall response rate
Plasma exosome levels

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Radiation Therapy
1
Stereotactic Body Radiation Therapy
1
Radiation Therapy

Trial Design

1 Treatment Group

Treatment (atezolizumab, surgery, radiation therapy)
1 of 1

Experimental Treatment

18 Total Participants · 1 Treatment Group

Primary Treatment: Radiation Therapy · No Placebo Group · Phase 2

Treatment (atezolizumab, surgery, radiation therapy)Experimental Group · 3 Interventions: Radiation Therapy, Atezolizumab, Therapeutic Conventional Surgery · Intervention Types: Radiation, Biological, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7130
Atezolizumab
FDA approved
Therapeutic Conventional Surgery
2005
Completed Phase 3
~8410

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor
1,499 Previous Clinical Trials
565,050 Total Patients Enrolled
Arnaud BewleyLead Sponsor
National Cancer Institute (NCI)NIH
13,151 Previous Clinical Trials
41,162,762 Total Patients Enrolled
1 Trials studying Cutaneous Squamous Cell Carcinoma of the Head and Neck
100 Patients Enrolled for Cutaneous Squamous Cell Carcinoma of the Head and Neck

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be 18 years or older.
There is enough tumor tissue available for testing biomarkers and PD-L1 levels.
You are capable of making your own decisions and have given your consent in writing.
Your cancer can be measured using a specific type of imaging test called iRECIST.
You have a type of skin cancer called cutaneous squamous cell carcinoma that has spread to lymph nodes in your head and/or neck, but the original source of the cancer is not clear. You are eligible if the cancer can be surgically removed.
You have head and neck cancer that has spread to nearby areas but not to distant parts of the body, and the original location of the cancer is unknown or in the past.
You are able to perform daily activities without getting very tired or needing much help.
Your cancer can be removed through surgery according to the usual treatment standards.
If you are a woman who is able to become pregnant, you must agree to use highly effective birth control methods during the study and for 5 months after the last dose of atezolizumab. Highly effective methods include getting your tubes tied, using a hormone-releasing IUD, using a copper IUD, or your partner getting a vasectomy. Simple methods like tracking your period or withdrawal are not enough.
If you are a man, you must either not have sex or use birth control to prevent pregnancy during the trial.
References

Frequently Asked Questions

What safety protocols are being implemented to ensure the efficacy of Radiation Therapy?

"We assigned Radiation Therapy a score of 2, as there is existing evidence for its safety but no data to confirm its efficacy." - Anonymous Online Contributor

Unverified Answer

Is enrollment still possible for this trial?

"Affirmative. Per the information published on clinicaltrials.gov, this medical investigation is currently enlisting participants; it was posted in December 2021 and revised in January 2022. The trial requires 18 individuals from 1 site to join." - Anonymous Online Contributor

Unverified Answer

Is this investigation a pioneering effort?

"Since 2008, Radiation Therapy has been the focus of numerous studies. The initial research was sponsored by Hoffmann-La Roche and involved 720 patients, eventually leading to Phase 2 approval for this medication. Currently, 351 trials are active in 1646 cities within 74 countries worldwide." - Anonymous Online Contributor

Unverified Answer

How many participants have signed up to take part in the clinical trial so far?

"That is correct. Clinicaltrials.gov reveals that this medical trial, which was first published on December 7th 2021, is actively recruiting participants now. 18 patients are needed from a single clinical site for the study's completion." - Anonymous Online Contributor

Unverified Answer

What maladies can be remedied with Radiation Therapy?

"Through the use of Radiation Therapy, small cell lung cancer (SCLC), malignant neoplasms and non-small cell lung carcinoma can be addressed." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top