Condition category
Cancer
Date applied
04/08/2009
Date assigned
19/08/2009
Last edited
19/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Hamm-Ming Sheu

ORCID ID

Contact details

No. 138
Sheng-Li Road
Department of Dermatology
National Cheng Kung University Hospital
Tainan
704
Taiwan
hmsheu@mail.ncku.edu.tw

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCCD06003A

Study information

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)

Acronym

Study hypothesis

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

Human Experiment and Ethics Committee of National Cheng Kung University Hospital approved on the 20th July 2007 (ref: HR-94-72).

Study design

Single centre phase II open-label study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Human cutaneous squamous cell carcinoma in situ (actinic keratosis and Bowen’s 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

Phase

Phase II

Drug names

SR-T100® gel

Primary outcome measures

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 trial start date

01/12/2007

Overall trial end date

30/06/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

15 patients for actinic keratosis and 15 patients for Bowen's disease

Participant 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

Recruitment start date

01/12/2007

Recruitment end date

30/06/2009

Locations

Countries of recruitment

Taiwan

Trial participating centre

No. 138, Sheng-Li Road
Tainan
704
Taiwan

Sponsor information

Organisation

G&E Herbal Biotech (Taiwan)

Sponsor details

No.26
Lane 31
Sec. 1
HuanDong Rd.
Tainan Science Park
ShnShih Township
Tainan County
744
Taiwan
+886 (0)6 505 2976
kwkuo@geherbs.com.tw

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

G&E Herbal Biotech (Taiwan) (ref: RDP009)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Department of Industrial Technology, Ministry of Economic Affairs (Taiwan) (ref: 97-EC-17-A-20-I1-0003)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes