Study on Radiotherapy with Cisplatin vs. Docetaxel-Cetuximab for Head and Neck Cancer: Exploring ERCC1 Biomarker Effects

Sponsor: Christopher Wilke

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02128906

Provider View

This clinical trial is comparing two chemotherapy combinations to find out which is more effective for treating advanced head and neck cancer. The study also looks at the side effects of these treatments and how a specific biomarker, ERCC1, affects the results.

Patient Parameters

Program Overview

The purpose of this study is to determine which chemotherapy combination works better for treating locally advanced head and neck squamous cell carcinoma (HNSCC). Patients will receive radiation therapy along with either cisplatin or a combination of docetaxel and cetuximab. The study will also explore how the presence of a biomarker called ERCC1 in the tumor affects treatment outcomes.

Description

In this study, patients will be randomly assigned to receive one of two chemotherapy treatments along with radiation therapy.

  • Cisplatin Group: Patients will receive cisplatin through an IV once a week for 7 weeks. If radiation treatment extends beyond 7 weeks due to technical reasons, an additional dose of cisplatin may be given. If a dose is missed, it will not be made up later.

  • Docetaxel-Cetuximab Group: Patients will receive cetuximab through an IV once a week for 7 weeks, along with docetaxel. Cetuximab can be given before or after the radiation session on the same day. If a dose is missed, it will not be made up later.

The study will monitor the effectiveness and side effects of these treatments, and how they relate to the ERCC1 biomarker in the tumor.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with specific types of head and neck cancer, such as squamous cell carcinoma, with no spread to distant parts of the body.
  • Cancer must be at stage III, IVa, or IVb, as determined by imaging and exams.
  • For oropharyngeal cancer, the p16 status must be known before starting the study.
  • No previous surgery intended to cure the current cancer diagnosis.
  • No previous chemotherapy or radiation for head and neck cancer.
  • Must have measurable cancer according to specific criteria.
  • Must be 18 years or older.
  • Must have good overall health with an ECOG performance status of 0 or 1.
  • Must have specific blood test results within normal ranges.
  • Women must not be pregnant or breastfeeding and must agree to use contraception.
  • Must not have had severe allergic reactions to similar treatments in the past.
  • Must not have serious heart conditions or uncontrolled illnesses.
  • Must provide a tumor sample for ERCC1 testing.
  • Must sign an informed consent form agreeing to participate in the study.

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