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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Roswell Park Cancer Institute
Buffalo, New York, United States
University of Rocherster
Rochester, New York, United States
Rate of Tumor Response as Evaluated by Response Evaluation Criteria in Solid Tumors Version 1.1
Objective tumor response will be tabulated overall.
Time frame: At 24 months
Change in Quality of Life as Measured by the University of Washington Quality of Life Questionnaire Version 4
In the analysis of QoL simple data analyses will initially take place including individual participant-level profile plots and overall mean plots used to examining the mean structure. Formal statistical examination of longitudinal patterns will be done through the use of a mixed model. Once the model is fit, specific linear contrasts based on the estimated model parameters will be constructed and used to test hypotheses concerning between time points and between group comparisons
Time frame: Baseline up to 24 months
Adverse Events as Graded by CTCAE Version 4.0 Are Reported
The frequency of toxicities will be tabulated by grade.
Time frame: Up to 30 days after administration of HPPH
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Ancillary studies
Undergo standard of care surgery