Basal Cell CarcinomaPhase 3NCT06150144
The Efficacy and Safety of Using Intralesional 5-fluorouracil for Basal Cell Carcinoma
A Phase 3 study testing 5-Fluorouracil and SURGERY in people with Basal Cell Carcinoma and BCC, run by University of Aleppo at 1 site in Syria.
Trial summary
The investigators want to assess the safety and efficacy of using intralesional 5-FU for the management of different types of BCC (including all the types EXCEPT the infiltrative one), by estimating different outcomes after the intralesional administration of 5-FU to BCC patient. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Basal Cell Carcinoma, BCC
- What is being tested?
- 5-Fluorouracil and SURGERY
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSyria
- Study dates
- 25 May 2023to 25 May 2025
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 5 Years to 90 Years (Child, Adult, Older Adult).
- Volunteer to participate in study
- Superficial lesion
- Nodular lesion (x ≤ 1.5 cm) patients are seen at the outpatient Department or in the dermatology wards at Aleppo University Hospital (AUH) over 12 months' period.
Who cannot join
- Ulcerative.
- Nodular lesion (x ≥ 1.5 cm)
Trial locations and contacts
1 site in 1 country.
Syria1 site, 1 recruiting
- Recruiting
Ibrahim Arnaout
Aleppo
Ibrahim Arnaout, M.D., +963993279977, ibrahim.arnaout25@gmail.com
George Zakhour, M.D.
About this study
Official title: The Efficacy and Safety of Using Intralesional 5-fluorouracil for Basal Cell Carcinoma: Clinical Trail
The investigators want to assess the safety and efficacy of using intralesional 5-FU for the management of different types of BCC (including all the types EXCEPT the infiltrative one), by estimating different outcomes after the intralesional administration of 5-FU to BCC patient. Patients are randomly selected from the outpatient dermatologic clinic in the Aleppo University Hospital (AUH) over a period of 12 months and then these patients are followed up over another 12 months.
Read the detailed description
Brief Description: The investigatorswant to assess the safety and efficacy of using intralesional 5-FU for the management of different types of BCC (including all the types EXCEPT the infiltrative one), by estimating different outcomes after the intralesional administration of 5-FU to BCC patient. Patients are randomly selected from the outpatient dermatologic clinic in the Aleppo University Hospital (AUH) over a period of 12 months and then these patients are followed up over another 12 months.
Detailed Description: Clinicians routinely consider surgical removal as the best and sometimes the only cost-effective treatment of Basal cell carcinoma, but several studies have discussed other promising treatment approaches for BCC including 5% 5-FU cream which is indicated for the treatment of superficial BCC, in addition many studies have investigated the efficacy of the combination of 5-FU with Imiquimode or cryoablation presenting promising results, however when searching the medical literature there was only few studies dealing with types other than superficial BCC, in addition intralesional administration of 5-FU alone was not thoroughly assessed so far even though there are some studies showing positive results suggesting 5-FU to be a cost-effective alternative to surgical excision, but as these papers are asking for further studies and stronger evidence the invistigators decided to conduct this study in accordance with the best recommendations reached by latest medical literature.
- Conditions
- Basal Cell Carcinoma, BCC
- Being tested
- 5-Fluorouracil, SURGERY
- Keywords
- Surgical excision, Basal cell carcinoma, clinical Trail, intralesional 5-fluorouracil
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-FluorouracilDrug
Also called 5-FU
The invistigators want to assess the safety and efficacy of using intralesional 5-FU for the management of different types of BCC (including all the types EXCEPT the infiltrative one), by estimating different outcomes after the intralesional administration of 5-FU to BCC patient. Patients are randomly selected from the outpatient dermatologic clinic in the Aleppo University Hospital (AUH) over a period of 12 months and then these patients are followed up over another 12 months.
SURGERYOther
Total excision of the lesion
| Study group | Role | What they receive |
|---|---|---|
| Patients with intralesional 5-fluorouracil. | Experimental | Not described Receives: Drug: 5-Fluorouracil |
| Patients with Surgery | Active comparator | Not described Receives: Other: SURGERY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histologic complete response rate
defined by absence of any tumor on the basis of histologic analysis of the excised specimen.
Measured: 1 - 2 months
Secondary outcomes (1)
Sides effect
The patient will be monitored and followed up for 365 days after the injection.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start25 May 2023
- Primary completion25 May 2025 (estimated)
- Study completion25 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aleppo
- Sponsor type
- University, hospital or other
- Collaborators
- Aleppo University Hospital
- Responsible party
- Principal investigator, Ibrahim Arnaout, University of Aleppo
- Investigators
- Noura Abdulrahman, M.D., Principal investigator, Department of Dermatology and Venereology, Faculty of Medicine, University of Aleppo, Aleppo, SyriaRama Haj mharram, M.D., Study director, Department of Dermatology and Venereology, Faculty of Medicine, University of Aleppo, Aleppo, SyriaAhmad Yamen Arnaout, M.D., Study director, Faculty of Medicine, University of Aleppo, Aleppo, Syria.Silva Ishkhanian, PhD, Study director, Department of Dermatology and Venereology, Faculty of Medicine, University of Aleppo, Aleppo, Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150144
- Sponsor's protocol ID
- intralesional 5-FU for BCC
- Status last verified
- Dec 2023
- First submitted
- 17 Nov 2023
- Last updated
- 2 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not available to other researcher