Stage I Oral Cavity Squamous Cell Carcinoma Clinical Trial
Official title:
A Randomized Multicenter Phase II Study Using (2-1[Heyloxyethyl]-2-Devinylpyropheophorbide-a) (HPPH) With PDT Versus Standard of Care Surgery for Patients With T1/T2 N0 Squamous Cell Carcinoma of the Oral Cavity
This randomized phase II clinical trial studies how well photodynamic therapy with HPPH works compared to standard of care surgery in treating patients with oral cavity cancer. Photodynamic therapy can destroy or control disease by using a combination of drug, such as HPPH, and light and may be as effective as surgery in treating patients with oral cavity cancer.
PRIMARY OBJECTIVES: I. To test the non-inferiority of photodynamic therapy (PDT) to standard of care surgery by comparing the rate of tumor response after PDT to those observed after surgery, at 24 months post treatment. SECONDARY OBJECTIVES: I. To determine quality of life (QoL) at 6, 12, 18 and 24 months post PDT or surgery. II. To assess the toxicity using the Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE Version 4.0). TERTIARY OBJECTIVES: I. Immune markers (T cells). II. To investigate the correlation of the diffuse reflectance optical spectroscopy with tumor response to PDT. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo standard of care surgery on day 1. ARM II: Patients receive HPPH intravenously (IV) over 1 hour on day 0 and undergo PDT on day 1. After completion of study treatment, patients are followed up every 3-4 months in year 1 and every 3-6 months in year 2. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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Phase 2 | |
| Terminated |
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Phase 1 |