A Study to Evaluate the Efficacy and Safety of Radion™-Pdt in Patients With Oral Precancerous Lesion
|ClinicalTrials.gov Identifier: NCT03279744|
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : January 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Erythroleukoplakia of Mouth Verrucous Hyperplasia of Oral Mucosa||Drug: Radion™-pdt||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||September 6, 2017|
|Actual Primary Completion Date :||September 4, 2019|
|Actual Study Completion Date :||December 20, 2019|
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279744
|National Taiwan University Hospital|
|Taipei, Zhongzheng Dist, Taiwan, 100|
|Principal Investigator:||Hsin-Ming Chen||National Taiwan University Hospital|