Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity Clinical Trial
Official title:
A Randomized Multicenter Phase II Study Using HPPH With PDT Versus Standard of Care Surgery for Patients With T1/T2 Squamous Cell Carcinoma of the Oral Cavity
This randomized phase II trial studies how well photodynamic therapy with HPPH works in treating patients with squamous cell carcinoma of the oral cavity. Photodynamic therapy uses HPPH that becomes active when it is exposed to a certain kind of light. When the drug is active, cancer cells are killed. This may be effective against squamous cell carcinoma of the oral cavity.
PRIMARY OBJECTIVES:
I. To test the non-inferiority of photodynamic therapy (PDT) to standard of care surgery.
SECONDARY OBJECTIVES:
I. To determine improvement in quality of life (QoL) using the University of Washington
Quality of life questionnaire version 4.
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).
III. To explore progression-free survival in this patient population treated with HPPH
mediated PDT.
TERTIARY OBJECTIVES:
I. Immune markers (T cells). II. To investigate the correlation of the tri-modal optical
spectroscopy with tumor response to PDT.
OUTLINE: Patients are randomized to 1 of 2 treatments 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. Approximately 24
hours later, patients undergo photodynamic therapy on day 1.
After completion of study treatment, patients are followed up 3-4 months for 1 year, 3-6
months for 1 year, 4-8 months for 1 year, and once a year for 2 years.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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