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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Using Intralesional 5-fluorouracil for Basal Cell Carcinoma: Clinical Trail
- ClinicalTrials.gov ID
- NCT06150144
- Acronym / sponsor ID
- intralesional 5-FU for BCC
- Conditions
- Basal Cell Carcinoma, BCC
- Keywords
- Surgical excision, Basal cell carcinoma, clinical Trail, intralesional 5-fluorouracil
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of AleppoUniversity, hospital or other
- Collaborators
- Aleppo University Hospital
- Study start
- 25 May 2023 (actual)
- Primary completion
- 25 May 2025 (estimated)
- Study completion
- 25 May 2025 (estimated)
- First posted
- 29 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with intralesional 5-fluorouracil. | Experimental | Drug: 5-Fluorouracil |
| Patients with Surgery | Active comparator | Other: SURGERY |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Ulcerative.
- Nodular lesion (x ≥ 1.5 cm)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-FluorouracilAlso: 5-FUThe 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. | Drug | Patients with intralesional 5-fluorouracil. |
| SURGERYTotal excision of the lesion | Other | Patients with Surgery |
Primary outcome
Histologic complete response rate
Time frame: 1 - 2 months
defined by absence of any tumor on the basis of histologic analysis of the excised specimen.
1 secondary outcome
Sides effect
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Individual participant dataSharing planned: No. Not available to other researcher
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noura Abdulrahman, M.D. principal investigator
Department of Dermatology and Venereology, Faculty of Medicine, University of Aleppo, Aleppo, Syria
Rama Haj mharram, M.D. study director
Department of Dermatology and Venereology, Faculty of Medicine, University of Aleppo, Aleppo, Syria
Ahmad Yamen Arnaout, M.D. study director
Faculty of Medicine, University of Aleppo, Aleppo, Syria.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ibrahim Arnaout, M.D. Candidate (+963993279977, ibrahim.arnaout25@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histologic complete response rate (time frame: 1 - 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.