RecruitingPhase 2NCT02128906

Radiotherapy With Cisplatin vs. Docetaxel-cetuximab in HNSCC: ERCC1 Biomarker Enrichment and Interaction Design

A Randomized, Phase II Study of Definitive Radiotherapy With Concurrent Cisplatin vs. Docetaxel-cetuximab in Locally Advanced Head and Neck Squamous Cell Carcinoma: an ERCC1 Biomarker Enrichment and Interaction Design

Sponsor

Christopher Wilke

Enrollment

120 participants

Start Date

Dec 23, 2013

Study Type

INTERVENTIONAL

Conditions

Squamous Cell Carcinoma

Summary

The goal of this clinical research study is to learn which chemotherapy combination may be more effective in treating locally advanced head and neck squamous cell carcinoma (HNSCC). The side effects of these combinations will also be studied. This study treatment consists of intensity-modulated radiation therapy (IMRT) and concurrent chemotherapy. For study chemotherapy, patients will be randomized between cisplatin or the combination of docetaxel and cetuximab. Subjects will be stratified depending on HPV status and the presence of ERCC-1 \[4F9\] in the tumor prior to randomization. The study will evaluate cisplatin vs. docetaxel-cetuximab in the overall population, and test which radiation and chemotherapy combination works best in relationship to how much ERCC-1 \[4F9\] is expressed in a tumor.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two chemotherapy regimens combined with radiation therapy for patients with head and neck cancers (in the throat, voice box, or lower throat area), looking at whether a genetic marker called ERCC1 can predict which chemotherapy combination works best. **You may be eligible if...** - You have confirmed squamous cell carcinoma (a common type of cancer) in the throat (oropharynx), voice box (larynx), or lower throat (hypopharynx) - Your cancer is stage III, IVa, or IVb and has not spread to distant organs - You have not yet had surgery intended to cure the cancer - Your general health is good enough to tolerate combined chemotherapy and radiation **You may NOT be eligible if...** - Your cancer has spread to other parts of the body - You have already received chemotherapy or radiation for this diagnosis - You have serious medical conditions that prevent treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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