Photodynamic Therapy With HPPH Compared to Standard of Care Surgery in Treating Patients With Oral Cavity Cancer
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|ClinicalTrials.gov Identifier: NCT03090412|
Recruitment Status : Recruiting
First Posted : March 24, 2017
Last Update Posted : February 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Stage I Oral Cavity Squamous Cell Carcinoma Stage II Oral Cavity Squamous Cell Carcinoma||Drug: HPPH Other: Laboratory Biomarker Analysis Drug: Photodynamic Therapy Other: Quality-of-Life Assessment Procedure: Therapeutic Conventional Surgery||Phase 2|
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.
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).
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 (Clinical Trial)|
|Estimated Enrollment :||114 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||March 30, 2017|
|Estimated Primary Completion Date :||November 2, 2020|
|Estimated Study Completion Date :||November 2, 2021|
Experimental: Arm I (surgery)
Patients undergo standard of care surgery on day 1.
Other: Quality-of-Life Assessment
Other Name: Quality of Life AssessmentProcedure: Therapeutic Conventional Surgery
Undergo standard of care surgery
Experimental: Arm II (HPPH, PDT)
Patients receive HPPH IV over 1 hour on day 0 and undergo PDT on day 1.
Other Name: PhotochlorOther: Laboratory Biomarker Analysis
Correlative studiesDrug: Photodynamic Therapy
Other Names:Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
- Rate of tumor response as evaluated by Response Evaluation Criteria in Solid Tumors version 1.1 [ Time Frame: At 24 months ]Objective tumor response will be tabulated overall.
- Change in quality of life as measured by the University of Washington Quality of Life questionnaire version 4 [ Time Frame: Baseline up to 24 months ]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
- Incidence of adverse events as graded by CTCAE version 4.0 [ Time Frame: Up to 30 days after administration of HPPH ]The frequency of toxicities will be tabulated by grade.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090412
|United States, New York|
|Roswell Park Cancer Institute||Recruiting|
|Buffalo, New York, United States, 14263|
|Contact: Roswell Park 877-275-7724 AskRPCI@RoswellPark.org|
|Principal Investigator: Hassan Arshad|
|University of Rocherster||Recruiting|
|Rochester, New York, United States, 14642|
|Contact: Paul Allen 585-275-1186 Paul_Allen@URMC.Rochester.edu|
|Principal Investigator:||Hassan Arshad||Roswell Park Cancer Institute|