Study on Cisplatin and Radiation Therapy for Head and Neck Cancer and Its Link to Oxidative Stress

Sponsor: Susanne Arnold

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02994069

Provider View

This clinical trial is exploring the effects of combining cisplatin chemotherapy with radiation therapy for patients with advanced head and neck cancer. The study aims to understand how cisplatin affects oxidative stress levels in these patients.

Patient Parameters

Program Overview

The study is investigating how combining cisplatin chemotherapy with radiation therapy can help treat advanced head and neck cancer. Researchers are particularly interested in how cisplatin, a chemotherapy drug, affects oxidative stress levels in patients. Participants will receive radiation therapy to the primary tumor and affected lymph nodes, along with cisplatin either weekly or every three weeks. The study will monitor the relationship between cisplatin's side effects and the levels of reactive oxygen species it generates in the body.

Description

Participants in this study will be divided into two groups based on their cancer status:

  • Cohort 1: Patients with advanced head and neck cancer that cannot be surgically removed.
  • Cohort 2: Patients who have had surgery but are at high risk of cancer returning due to certain factors like cancer spread to lymph nodes or invasive cancer at the surgery site.

Patients will be randomly assigned to receive one of two cisplatin treatment schedules during their radiation therapy:

  • Arm 1: Cisplatin every three weeks.
  • Arm 2: Cisplatin once a week.

Radiation therapy will be given daily over 6-7 weeks, and both treatments will start on the same day. The study will continue for up to 7 weeks unless there are treatment delays due to side effects or other health issues. Participants will be monitored for two years after treatment to track side effects and progression-free survival (PFS).

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with squamous cell carcinoma of the head and neck, affecting areas like the oral cavity, throat, or larynx.
  • For Cohort 1: Cancer that cannot be surgically removed and no distant spread.
  • For Cohort 2: Had surgery but at high risk of cancer returning, with specific high-risk features.
  • Must be 18 years or older.
  • Good overall health with a performance status of 0, 1, or 2.
  • Life expectancy of more than 12 weeks.
  • Normal organ and bone marrow function based on recent tests.
  • No prior chemotherapy for the current cancer, but previous treatment for other head and neck cancers is allowed if in remission.
  • Agree to use effective birth control during and after treatment.
  • Able to understand and sign a consent form.

Exclusion Criteria

  • Recent chemotherapy or radiation within the last 4-6 weeks.
  • Currently taking other experimental drugs.
  • Allergic to cisplatin or similar drugs.
  • Significant hearing loss.
  • Other cancers, except for certain types in remission or treated early-stage cancers.
  • Cancer in the nasopharynx or salivary glands.
  • Cancer that has spread to distant parts of the body, including the brain.
  • Uncontrolled health issues like severe infections, heart problems, or mental health conditions.
  • Pregnant or breastfeeding women.
  • Uncontrolled HIV infection.

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