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Trial record 35 of 7081 for:    Oral Cancer | ( Map: United States )

Photodynamic Therapy With HPPH Compared to Standard of Care Surgery in Treating Patients With Oral Cavity Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03090412
Recruitment Status : Recruiting
First Posted : March 24, 2017
Last Update Posted : November 8, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Tracking Information
First Submitted Date  ICMJE March 20, 2017
First Posted Date  ICMJE March 24, 2017
Last Update Posted Date November 8, 2018
Actual Study Start Date  ICMJE March 30, 2017
Estimated Primary Completion Date November 2, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03090412 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Photodynamic Therapy With HPPH Compared to Standard of Care Surgery in Treating Patients With Oral Cavity Cancer
Official Title  ICMJE 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
Brief 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.
Detailed Description


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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stage I Oral Cavity Squamous Cell Carcinoma
  • Stage II Oral Cavity Squamous Cell Carcinoma
Intervention  ICMJE
  • Drug: HPPH
    Given IV
    Other Name: Photochlor
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Drug: Photodynamic Therapy
    Undergo PDT
    Other Names:
    • PDT
    • Photoradiation Therapy
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Name: Quality of Life Assessment
  • Procedure: Therapeutic Conventional Surgery
    Undergo standard of care surgery
Study Arms  ICMJE
  • Experimental: Arm I (surgery)
    Patients undergo standard of care surgery on day 1.
    • Other: Quality-of-Life Assessment
    • Procedure: Therapeutic Conventional Surgery
  • Experimental: Arm II (HPPH, PDT)
    Patients receive HPPH IV over 1 hour on day 0 and undergo PDT on day 1.
    • Drug: HPPH
    • Other: Laboratory Biomarker Analysis
    • Drug: Photodynamic Therapy
    • Other: Quality-of-Life Assessment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 20, 2017)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2, 2021
Estimated Primary Completion Date November 2, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
  • Participants with previously untreated T1/T2 N0 squamous cell carcinoma of the oral cavity with or without extension to the oropharynx
  • Histologically confirmed squamous cell carcinoma of the target tumor(s)
  • Tumor thickness is 4 mm or less (measured clinically and/or by computed tomography [CT] or magnetic resonance imaging [MRI] scan)
  • CT or MRI of the neck to confirm staging
  • Tumor accessible for unrestricted illumination for photodynamic therapy (PDT) (accessibility as determined by the physician)
  • Life expectancy of at least 12 months in the judgment of the physician
  • Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately
  • Participant or legal representative must understand the investigational nature of this study and sign an Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

  • Those who have had chemotherapy or radiotherapy or targeted agents within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Those with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
  • Those with porphyria or with known hypersensitivity to porphyrins or porphyrin-like compounds
  • White blood cells (WBC) < 4,000
  • Total serum bilirubin > 2 mg/dL
  • Serum creatinine > 2 mg/dL
  • Alkaline phosphatase (hepatic) or serum glutamic-oxaloacetic transaminase (SGOT) > 3 times the upper normal limit
  • Diagnostic biopsy reveals perineural invasion (PNI) and/or lymphovascular invasion (LVI)
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Nodal disease as detected by clinical exam or CT
  • Pregnant or nursing females
  • Unwilling or unable to follow protocol requirements
  • Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
  • Received an investigational agent within 30 days prior to enrollment
  • Trismus or compromised airway
  • Previous treatment in the target tumor area
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03090412
Other Study ID Numbers  ICMJE I 33616
NCI-2017-00441 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 33616 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roswell Park Cancer Institute
Study Sponsor  ICMJE Roswell Park Cancer Institute
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Hassan Arshad Roswell Park Cancer Institute
PRS Account Roswell Park Cancer Institute
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP