Human cutaneous squamous cell carcinoma in situ (actinic keratosis and Bowen?s disease) Cancer Carcinoma in situ of other and unspecified sites
Conditions
Interventions
Only one lesion will be selected for treatment and assessment in each patient. SR-T100® gel will be applied once daily on the targeted lesion and covered with an occlusive dressing. Patients will be i
Sponsors
G&E Herbal Biotech (Taiwan)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet ALL of the inclusion criteria for the entry of this study: 1. Male or female; aged greater than or equal to 20 years old 2. Patients must have histologically confirmed squamous cell carcinoma in situ (actinic keratosis or Bowen's Disease) for the target lesion 3. Patients must have a measureable lesion 5 mm or larger for actinic keratosis of 10 mm or larger for Bowen's disease 4. Patients must have a performance of less than or equal to 2 (Eastern Cooperative Oncology Group [ECOG]) 5. Patients who have signed an approved written informed consent
Exclusion criteria
Exclusion criteria: Patients will be excluded from this study for ANY of the following reasons: 1. Patients with histologic subtypes other than squamous cell carcinoma in situ (actinic keratosis or Bowen's disease) 2. Patients with tumour extending into the oral cavity, nostrils, eyelids, urethra, anus, vagina or rectum 3. Patients who have grossly suspicious or inflamed nodes on physical examination 4. Patients with grossly infected tumours 5. Patients with recurrent invasive squamous cell carcinoma 6. Patients with a history of other invasive malignancies, if there is any evidence of the other malignancy being present within the past 5 years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy. 7. Use of any investigational drug in the 30 days before screening 8. Pregnant or lactating women or women of childbearing potential using inadequate contraceptive methods
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the response rate of SR-T100® in patients with cutaneous squamous cell carcinoma in situ (actinic keratosis and Bowen's disease), defined as the proportion of patients whose lesion size (length x width x height) is reduced greater than 75%. Measured until tumour is clinically cleared or until 16 weeks of treatment completed. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Complete clearance rate, defined as the proportion of patients with no clinically visible actinic keratosis and Bowen's disease lesions in the treatment area 2. Partial clearance rate, defined as the proportion of patients with at least a 75% reduction of actinic keratosis and Bowen's disease lesion size (length x width x height) in the treatment area 3. Histological response rate: proportion of patients with biopsy proven clearance of cutaneous squamous cell carcinoma in situ (actinic keratosis and Bowen's disease) 4. The safety profile of SR-T100® gel Measured until tumour is clinically cleared or until 16 weeks of treatment completed. | — |
Countries
Taiwan
Outcome results
None listed