Photodynamic Therapy With HPPH Compared to Standard of Care Surgery in Treating Patients With Oral Cavity Cancer
NCT03090412 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2
Last updated 2022-06-02
Summary
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.
Conditions
- Stage I Oral Cavity Squamous Cell Carcinoma
- Stage II Oral Cavity Squamous Cell Carcinoma
Interventions
- DRUG
-
HPPH
Given IV
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- DRUG
-
Photodynamic Therapy
Undergo PDT
- OTHER
-
Quality-of-Life Assessment
Ancillary studies
- PROCEDURE
-
Therapeutic Conventional Surgery
Undergo standard of care surgery
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Roswell Park Cancer Institute
lead OTHER
Principal Investigators
-
Jon Chan · Roswell Park Cancer Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-03-07
- Primary Completion
- 2021-08-01
- Completion
- 2021-08-06
- FDA Drug
- Yes
Countries
- United States
Study Locations
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