Efficacy and safety of topical SR-T100® gel in the treatment of human cutaneous squamous cell carcinoma in situ (actinic keratosis and Bowen's disease)
| ISRCTN | ISRCTN30540872 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30540872 |
| Secondary identifying numbers | MCCD06003A |
- Submission date
- 04/08/2009
- Registration date
- 19/08/2009
- Last edited
- 19/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Hamm-Ming Sheu
Scientific
Scientific
No. 138, Sheng-Li Road
Department of Dermatology
National Cheng Kung University Hospital
Tainan
704
Taiwan
| hmsheu@mail.ncku.edu.tw |
Study information
| Study design | Single centre phase II open-label study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | An open phase II study to assess the efficacy and safety of topical SR-T100® gel in the treatment of human cutaneous squamous cell carcinoma in situ (actinic keratosis and Bowen's disease) |
| Study objectives | In our preliminary animal study to evaluate the efficacy and toxicity of topical SR-T100® gel, using an approved protocol of ultraviolet B (UVB)-induced hairless mouse (HRS) cutaneous cell carcinoma, 35 of 40 squamous cell carcinomas (SCCs) disappeared within 10 weeks of treatment (once-daily). Besides the high complete response rate (87.5%) as compared with the conventional therapy, the most significant result was that no undesirable side effects were associated with the use of SR-T100® gel. We hypothesise that SR-T100® gel can be a potential alternative treatment for cutaneous squamous cell carcinoma in situ (actinic keratosis and Bowen's disease). |
| Ethics approval(s) | Human Experiment and Ethics Committee of National Cheng Kung University Hospital approved on the 20th July 2007 (ref: HR-94-72). |
| Health condition(s) or problem(s) studied | Human cutaneous squamous cell carcinoma in situ (actinic keratosis and Bowens disease) |
| Intervention | 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 instructed to apply the study gel to the entire area of target lesion including its peripheral normal skin approximately 1 cm around the tumour. Treatment will be continued until tumour is clinically cleared or until 16 weeks of treatment completed. The 16 week treatment is chosen on the basis of maximum duration treatment of topical drug on actinic keratosis and Bowen's disease previously reported. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | SR-T100® gel |
| Primary outcome measure | 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 outcome measures | 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. |
| Overall study start date | 01/12/2007 |
| Completion date | 30/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 15 patients for actinic keratosis and 15 patients for Bowen's disease |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2007 |
| Date of final enrolment | 30/06/2009 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
No. 138, Sheng-Li Road
Tainan
704
Taiwan
704
Taiwan
Sponsor information
G&E Herbal Biotech (Taiwan)
Industry
Industry
No.26, Lane 31
Sec. 1, HuanDong Rd.
Tainan Science Park
ShnShih Township
Tainan County
744
Taiwan
| Phone | +886 (0)6 505 2976 |
|---|---|
| kwkuo@geherbs.com.tw |
Funders
Funder type
Industry
G&E Herbal Biotech (Taiwan) (ref: RDP009)
No information available
Department of Industrial Technology, Ministry of Economic Affairs (Taiwan) (ref: 97-EC-17-A-20-I1-0003)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
