Study on Adding Chemotherapy or Chemo-Immunotherapy to Surgery for Advanced Head and Neck Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT07195734
This clinical trial is exploring whether adding chemotherapy or a combination of chemotherapy and immunotherapy to the usual surgery can improve treatment outcomes for patients with advanced head and neck cancer that has returned or is persistent.
Patient Parameters
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Program Overview
This study is testing if adding chemotherapy drugs (carboplatin and paclitaxel) or a combination of these drugs with an immunotherapy drug (cemiplimab) to the standard surgery can help treat patients with advanced head and neck cancer. The cancer must be PD-L1 positive, meaning it has a specific marker that may respond to immunotherapy. The trial aims to see if these additional treatments can kill more cancer cells than surgery alone.
Description
The main goal of this study is to compare how well patients do when they receive chemotherapy or chemo-immunotherapy before surgery, compared to those who only have the standard surgery. Researchers will look at how long patients live without the cancer coming back, overall survival rates, and any side effects or complications from the treatments.
Patients will be randomly assigned to one of three groups:
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Group 1: Patients will have the standard surgery. If they are at high risk, they will also receive radiation therapy and the chemotherapy drug cisplatin after surgery.
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Group 2: Patients will receive chemotherapy with carboplatin and paclitaxel before surgery. After surgery, high-risk patients will receive radiation therapy and cisplatin.
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Group 3: Patients will receive chemotherapy with carboplatin and paclitaxel, plus the immunotherapy drug cemiplimab before surgery. After surgery, high-risk patients will receive radiation therapy and cisplatin.
All patients will have regular scans and may have blood samples taken throughout the study. After treatment, patients will have follow-up visits to monitor their health and the effectiveness of the treatment.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with locally recurrent or persistent squamous cell carcinoma of the head and neck (SCCHN) in specific areas like the oral cavity, oropharynx, larynx, or hypopharynx.
- Cancer must be PD-L1 positive with a combined positive score (CPS) of 1 or higher.
- Must have insurance or other payment coverage for chemotherapy before surgery.
- Cancer must be measurable by standard criteria.
- Must be a candidate for surgery to remove the cancer.
- No evidence of cancer spread to distant parts of the body.
- Must be 18 years or older.
- Must have a good performance status, meaning they are fully active or able to carry out light work.
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
- Must have adequate blood cell counts and organ function as determined by specific tests.
- Must have completed any previous radiation therapy at least 6 months before joining the study.
- Must not have received certain cancer treatments within a specified time before joining the study.
- Must not have severe heart disease or active infections requiring IV treatment.
- Must not have severe nerve damage or allergies to study drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Banner University Medical Center - Tucson | 85719 | Tucson | Arizona |
| University of Arizona Cancer Center-North Campus | 85719 | Tucson | Arizona |
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| Sutter Medical Center Sacramento | 95816 | Sacramento | California |
| Emory Proton Therapy Center | 30308 | Atlanta | Georgia |
| Emory University Hospital Midtown | 30308 | Atlanta | Georgia |
| Rush MD Anderson Cancer Center | 60612 | Chicago | Illinois |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic | 50023 | Ankeny | Iowa |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic | 50325 | Clive | Iowa |
| Methodist Jennie Edmundson Hospital | 51503 | Council Bluffs | Iowa |
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