- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03279744
A Study to Evaluate the Efficacy and Safety of Radion™-Pdt in Patients With Oral Precancerous Lesion
A Prospective, Single-Arm, Open-Label, Phase II. Study to Evaluate the Efficacy and Safety of Photodynamic Therapy Using Radion™-Pdt in Patients With Oral Precancerous Lesion (Oral Verrucous Hyperplasia or Oral Erythroleukoplakia)
Study Overview
Status
Intervention / Treatment
Detailed Description
This is a single-center, single-arm, open-label study to evaluate the efficacy and safety of topical Radion™-pdt for treatment of patients with oral verrucous hyperplasia (OVH) or oral erythroleukoplakia (OEL).
Total duration of the study will be up to 40 weeks (from screening throughout study until completion) as follows:
- Screening (within 2 weeks before dosing)
- Treatment period (up to 14 weeks)
- Safety follow-up period (within 2 weeks after final treatment)
- Follow-up period (final treatment plus 4 weeks, 8 weeks, 16 weeks and 24 weeks respectively) All enrolled patients will receive up to 8 treatments (once every two weeks) during a maximum of 14-week study treatment period. The treated lesion will be clinically evaluated and documented (clinical photograph) at each treatment visit.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Zhongzheng Dist
-
Taipei, Zhongzheng Dist, Taiwan, 100
- National Taiwan University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients aged ≥20 years old;
- Patient with oral verrucous hyperplasia (OVH) or oral erythroleukoplakia (OEL) lesions with histological evidence of oral precancerous lesions. Besides, patients should have at least one lesion whose size should not exceed 4 cm in the greatest diameter and the distance between two lesions should not less than 1 cm.
- Patient who is willing and able to comply with study procedures and sign informed consent
Exclusion Criteria:
- Patients with history of hypersensitivity to any photosensitizer (including 5-aminolevulinic acid HCl or porphyrins), acute or chronic types of porphyria;
- Record of previous unsuccessful treatment with photodynamic therapy;
- Patients who have been diagnosed as having oral cancer or carcinoma in situ;
- Patients who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune, neurological, hematological, gastrointestinal or psychiatric disease as determined by the clinical judgment of the investigator;
- Patients with impaired hepatic function (defined as AST and/or ALT > 2× the upper limit of normal values), and/or impaired renal function (defined as serum creatinine > 1.5 mg/dL);
Female patient of childbearing potential who:
- is lactating; or
- has positive urine pregnancy test at visit -1; or
- refuses to adopt reliable method of contraception during the study;
- Patient has received any other investigational agent within 28 days or 5 half-lives, whichever is longer, prior to the first photodynamic therapy;
- Patient has a history of illegal substance abuse, drug addiction or alcoholism within 24 weeks prior to the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Single-Arm
Radion™-pdt
|
The Radion™-pdt will be applied topically to the lesion.
The Radion™-pdt applied dosage is about 0.1 mL/cm^2 and properly cover the entire lesion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The primary efficacy endpoints: the complete response rate is higher or equal to 70% of total
Time Frame: 2-week safety follow-up period after last treatment
|
The complete response rate at the end of treatment will be calculated by the proportion of complete response patients in total. The primary efficacy endpoints will be summarized by examining whether the complete response rate is higher or equal to 70% of total. Complete response (CR): lack of detectable lesion confirmed by visual evaluation. |
2-week safety follow-up period after last treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hsin-Ming Chen, National Taiwan University Hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRC241001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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