A Randomized Phase II/III Trial of De-Intensified Radiation Therapy for Patients with Early-Stage, P16-Positive, Non-Smoking Associated Oropharyngeal Cancer

Investigation of Reduced-Dose Radiation Therapy for Oropharyngeal Cancer

Recruiting
18 years - 100 years
All
Phase 2/3
5 participants needed
1 Location

Brief description of study.

The purpose of this study is to compare concurrent reduced-dose radiation therapy (RT) with cisplatin or concurrent reduced-dose radiation therapy with nivolumab to the current standard of care (standard-dose RT with cisplatin).

Detailed description of study

Participants will be randomly assigned to receive radiation plus either cisplatin or nivolumab.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Oropharyngeal Cancer
  • Age: 18 years - 100 years
  • Gender: All

Individuals at least 18 years of age with squamous cell carcinoma of the oropharynx.

Individuals with lifetime cumulative smoking history exceeding 10 pack-years will not be eligible.

Individuals with severe, active co-morbidity will not be eligible.

Women who are pregnant will not be eligible.

Updated on 19 Feb 2024. Study ID: 1912360365

This study investigates treatments for squamous cell carcinoma of the oropharynx, a type of throat cancer. The purpose is to compare different therapies using reduced-dose radiation. Participants will receive either radiation with cisplatin, a chemotherapy drug, or radiation with nivolumab, an immunotherapy drug.

Participants will be randomly assigned to one of the study arms. This means they will either receive radiation with cisplatin or radiation with nivolumab. The study aims to evaluate the effectiveness and safety of these treatments compared to the standard therapy.

  • Who can participate: Adults aged 18 and older with squamous cell carcinoma of the oropharynx can participate. Those with a smoking history over 10 pack-years, severe co-morbidities, or who are pregnant are not eligible.
  • Study details: Participants will be randomly assigned to receive radiation therapy with either cisplatin or nivolumab. A placebo is not used in this study.

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