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

Study results available
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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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03090412 on ClinicalTrials.gov