Back to results5-Fluorouracil and Calcipotriene for Treatment of Low Grade Skin Cancer
Primary Purpose
Superficial Basal Cell Carcinoma, Squamous Cell Carcinoma in Situ
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Combination cream of 5-fluorouracil and calcipotriene
5-fluorouracil cream
Sponsored by
About this trial
This is an interventional treatment trial for Superficial Basal Cell Carcinoma focused on measuring 5-fluorouracil cream, fluorouracil with calcipotriene
Eligibility Criteria
Inclusion Criteria:
- English-speaking
- Having a previously untreated, biopsy-proven Superficial Basal Cell Carcinoma (sBCC) or Squamous Cell Carcinoma in Situ (SCCis) of the skin <2 cm on the scalp, trunk, neck, or extremities, excluding hands, feet, and genitalia
- Having a previously untreated, biopsy-proven sBCC or SCCis on the face, hands, feet, and genitalia who decline surgery or are otherwise not surgical candidates
- Willing to undergo all protocol requirements and attend study-specific follow up clinic visits in addition to routine follow up visits
- Participants may have multiple lesions enrolled in the study so long as the individual lesions are greater than 2 cm from each other
- If a woman is of childbearing potential, the participant must be willing to take a pregnancy test before starting treatment and be on some form of birth control while receiving treatment. Birth control can include abstinence, oral contraceptive pill, intrauterine device, implanted birth control device, birth control patch, or the vaginal ring. The patient does not need to be on any form of birth control after they end therapy.
Exclusion Criteria:
- Current or prior field treatment within 2 cm of the target BCC or SCCis
- Periorbital lesions
- Lesions that have been previously treated
- Known allergy to any of the study medication ingredients
- History of solid organ transplant or current immunosuppression
- Genetic disorders associated with high skin cancer risk
- Arsenic exposure
- Cutaneous T-cell lymphoma
- Current or prior radiation therapy at the site of the sBCC or SCCis
- Women who are pregnant or currently breastfeeding
- Prior psoralen plus Ultraviolet light (UVA) treatment at the site
- Very high mortality risk at the start of the study
- Dihydropyrimidine dehydrogenase (DPD) enzyme deficiency
- Demonstrated hypercalcemia or evidence of vitamin D toxicity
- Lesions that extend into the oral, nasal or genital mucosa
Sites / Locations
- Boston Medical Center Dermatology ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Combination cream of 5-fluorouracil and calcipotriene
5-fluorouracil cream
Arm Description
Participants randomized to this group will receive treatment with the combination cream consisting of 5-fluorouracil and calcipotriene twice a day for 7 days and the treatment can be extended to 14 days based on evaluation at 7 days.
Participants randomized to this group will receive treatment with 5-fluorouracil cream twice a day for 28 days.
Outcomes
Primary Outcome Measures
Clearance rate of cancer lesions at 3 months
Clearance rate is defined as the percentage of lesions that are free of cancer based on clinical assessments which will be performed by the patient's dermatologist and via photos from a standardized full frontal angle.
Clearance rate of cancer lesions at 3 years
Clearance rate is defined as the percentage of lesions that are free of cancer based on clinical assessments which will be performed by the patient's dermatologist and via photos from a standardized full frontal angle.
Secondary Outcome Measures
Percent of participants that experience pain during treatment
Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will rate their pain from 1 to 5 where 1=no pain, 2= very mild, 3=mild, 4=moderate (requiring pain medication), 5=severe (requiring pain medication or physician contact). The number of participants with scores of 2 or higher will be divided by all participants.
Severity of pain during treatment
Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will rate their pain from 1 to 5 where 1=no pain, 2= very mild, 3=mild, 4=moderate (requiring pain medication), 5=severe (requiring pain medication or physician contact). Mean pain ratings will be calculated with higher mean scores suggesting more severe pain.
Percent of participants that experience redness during treatment
Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will rate their overall redness from 1 to 5 where 1=no redness, 2= very minimal, 3=minimal, 4=moderate, 5=severe. The number of participants with scores of 2 or higher will be divided by all participants.
Severity of redness during treatment
Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will rate their overall redness from 1 to 5 where 1=no redness, 2= very minimal, 3=minimal, 4=moderate, 5=severe. Mean redness ratings will be calculated with higher mean scores suggesting more severe redness.
Day of worst redness
For participants who experienced any redness, the mean day after treatment when the redness was worst will be calculated.
Percent of participants who experienced scaling/flaking
Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will be asked if they experienced any scaling/flaking. The number of participants who responded 'yes' will be divided by all participants.
Percent of participants who experienced skin itching
Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will be asked if they experienced any skin itching. The number of participants who responded 'yes' will be divided by all participants.
Percent of participants who experienced skin burning
Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will be asked if they experienced any skin burning. The number of participants who responded 'yes' will be divided by all participants.
Participant compliance with treatment
Compliance with treatment will be assessed by weighing the medicine tubes after treatment completion and comparing the weight, estimated in grams from fingertip units (FTU), with the expected weight based on the how much medicine should have been used given the treatment regimen. The closer this difference is to zero, the greater the compliance.
Participant satisfaction with treatment
Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will rate their satisfaction with the treatment from 1 to 5 where 1=very dissatisfied, 2= dissatisfied, 3=neutral, 4=satisfied, 5=very satisfied. Mean satisfaction ratings will be calculated with higher mean scores suggesting more treatment satisfaction.
Recurrence rate of cancer lesions at 1 year
The recurrence rate is the percentage of cancer lesions that recur which is the number that recur out of the number cleared.
Recurrence rate of cancer lesions at 3 years
The recurrence rate is the percentage of cancer lesions that recur which is the number that recur out of the number cleared.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05381597
Brief Title
5-Fluorouracil and Calcipotriene for Treatment of Low Grade Skin Cancer
Official Title
Combination of 5-Fluorouracil and Calcipotriene in the Treatment of Superficial Basal Cell Carcinomas and Squamous Cell Carcinomas in Situ
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2022 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators will compare the application of two different creams for the treatment of low-risk skin cancers-superficial basal cell carcinoma (sBCC) and squamous cell carcinoma in situ (SCCis). 5-Fluorouracil cream is currently FDA approved for the treatment of superficial basal cell carcinoma and is routinely used by dermatologists across the country and at Boston Medical Center (BMC) for SCCis. The normal treatment regimen is 4 weeks of the 5-fluorouracil cream for both skin cancers.
The application of a compounded cream consisting of 1:1 ratio 5-fluorouracil with calcipotriene will be tested. This combination cream has been shown to clear pre-skin cancers called actinic keratoses and prevent future skin cancers from developing. This combination cream for 7-14 days to see if this shorter treatment course provides clearance of the 2 types of skin cancer. This combination cream is successfully used in this manner to treat other subtypes of related skin cancers. This will be a pilot study with
The primary endpoint for this pilot randomized single blinded clinical trial will be the response to treatment (yes versus no). The lesions will be assessed clinically for clearance of cancer, as would normally be done and is consistent with how comparable studies have assessed clearance. Participants will be followed closely afterwards for three years with visits at 6 months, which does not vary from standard practice. If the lesions are not clear of cancer or equivocal clinically, the lesions will be re-biopsied and normal standard of care procedure will take place.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Superficial Basal Cell Carcinoma, Squamous Cell Carcinoma in Situ
Keywords
5-fluorouracil cream, fluorouracil with calcipotriene
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Combination cream of 5-fluorouracil and calcipotriene
Arm Type
Experimental
Arm Description
Participants randomized to this group will receive treatment with the combination cream consisting of 5-fluorouracil and calcipotriene twice a day for 7 days and the treatment can be extended to 14 days based on evaluation at 7 days.
Arm Title
5-fluorouracil cream
Arm Type
Active Comparator
Arm Description
Participants randomized to this group will receive treatment with 5-fluorouracil cream twice a day for 28 days.
Intervention Type
Drug
Intervention Name(s)
Combination cream of 5-fluorouracil and calcipotriene
Other Intervention Name(s)
compounded cream
Intervention Description
Apply the cream to the size of the lesion extending to the 0.5 cm area of skin surrounding the lesion.twice a day for 7 days and the treatment can be extended to 14 days based on evaluation at 7 days.
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil cream
Other Intervention Name(s)
usual treatment
Intervention Description
Apply the cream to the size of their lesion extending to the 0.5 cm area of skin surrounding the lesion twice daily for 28 days.
Primary Outcome Measure Information:
Title
Clearance rate of cancer lesions at 3 months
Description
Clearance rate is defined as the percentage of lesions that are free of cancer based on clinical assessments which will be performed by the patient's dermatologist and via photos from a standardized full frontal angle.
Time Frame
3 months
Title
Clearance rate of cancer lesions at 3 years
Description
Clearance rate is defined as the percentage of lesions that are free of cancer based on clinical assessments which will be performed by the patient's dermatologist and via photos from a standardized full frontal angle.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Percent of participants that experience pain during treatment
Description
Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will rate their pain from 1 to 5 where 1=no pain, 2= very mild, 3=mild, 4=moderate (requiring pain medication), 5=severe (requiring pain medication or physician contact). The number of participants with scores of 2 or higher will be divided by all participants.
Time Frame
3 months
Title
Severity of pain during treatment
Description
Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will rate their pain from 1 to 5 where 1=no pain, 2= very mild, 3=mild, 4=moderate (requiring pain medication), 5=severe (requiring pain medication or physician contact). Mean pain ratings will be calculated with higher mean scores suggesting more severe pain.
Time Frame
3 months
Title
Percent of participants that experience redness during treatment
Description
Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will rate their overall redness from 1 to 5 where 1=no redness, 2= very minimal, 3=minimal, 4=moderate, 5=severe. The number of participants with scores of 2 or higher will be divided by all participants.
Time Frame
3 months
Title
Severity of redness during treatment
Description
Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will rate their overall redness from 1 to 5 where 1=no redness, 2= very minimal, 3=minimal, 4=moderate, 5=severe. Mean redness ratings will be calculated with higher mean scores suggesting more severe redness.
Time Frame
3 months
Title
Day of worst redness
Description
For participants who experienced any redness, the mean day after treatment when the redness was worst will be calculated.
Time Frame
3 months
Title
Percent of participants who experienced scaling/flaking
Description
Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will be asked if they experienced any scaling/flaking. The number of participants who responded 'yes' will be divided by all participants.
Time Frame
3 months
Title
Percent of participants who experienced skin itching
Description
Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will be asked if they experienced any skin itching. The number of participants who responded 'yes' will be divided by all participants.
Time Frame
3 months
Title
Percent of participants who experienced skin burning
Description
Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will be asked if they experienced any skin burning. The number of participants who responded 'yes' will be divided by all participants.
Time Frame
3 months
Title
Participant compliance with treatment
Description
Compliance with treatment will be assessed by weighing the medicine tubes after treatment completion and comparing the weight, estimated in grams from fingertip units (FTU), with the expected weight based on the how much medicine should have been used given the treatment regimen. The closer this difference is to zero, the greater the compliance.
Time Frame
3 months
Title
Participant satisfaction with treatment
Description
Based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, participants will rate their satisfaction with the treatment from 1 to 5 where 1=very dissatisfied, 2= dissatisfied, 3=neutral, 4=satisfied, 5=very satisfied. Mean satisfaction ratings will be calculated with higher mean scores suggesting more treatment satisfaction.
Time Frame
3 months
Title
Recurrence rate of cancer lesions at 1 year
Description
The recurrence rate is the percentage of cancer lesions that recur which is the number that recur out of the number cleared.
Time Frame
1 year
Title
Recurrence rate of cancer lesions at 3 years
Description
The recurrence rate is the percentage of cancer lesions that recur which is the number that recur out of the number cleared.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
English-speaking
Having a previously untreated, biopsy-proven Superficial Basal Cell Carcinoma (sBCC) or Squamous Cell Carcinoma in Situ (SCCis) of the skin <2 cm on the scalp, trunk, neck, or extremities, excluding hands, feet, and genitalia
Having a previously untreated, biopsy-proven sBCC or SCCis on the face, hands, feet, and genitalia who decline surgery or are otherwise not surgical candidates
Willing to undergo all protocol requirements and attend study-specific follow up clinic visits in addition to routine follow up visits
Participants may have multiple lesions enrolled in the study so long as the individual lesions are greater than 2 cm from each other
If a woman is of childbearing potential, the participant must be willing to take a pregnancy test before starting treatment and be on some form of birth control while receiving treatment. Birth control can include abstinence, oral contraceptive pill, intrauterine device, implanted birth control device, birth control patch, or the vaginal ring. The patient does not need to be on any form of birth control after they end therapy.
Exclusion Criteria:
Current or prior field treatment within 2 cm of the target BCC or SCCis
Periorbital lesions
Lesions that have been previously treated
Known allergy to any of the study medication ingredients
History of solid organ transplant or current immunosuppression
Genetic disorders associated with high skin cancer risk
Arsenic exposure
Cutaneous T-cell lymphoma
Current or prior radiation therapy at the site of the sBCC or SCCis
Women who are pregnant or currently breastfeeding
Prior psoralen plus Ultraviolet light (UVA) treatment at the site
Very high mortality risk at the start of the study
Dihydropyrimidine dehydrogenase (DPD) enzyme deficiency
Demonstrated hypercalcemia or evidence of vitamin D toxicity
Lesions that extend into the oral, nasal or genital mucosa
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Sutherland, MD
Phone
(617) 358-9700
Email
anna.sutherland@bmc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandria Riopelle, MD
Phone
(617) 358-9700
Email
alexandria.riopelle@bmc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bilal Fawaz, MD
Organizational Affiliation
Dermatology, Boston University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center Dermatology Clinic
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bilal Fawaz, MD
Phone
617-358-9700
Email
bilal.fawaz@bmc.org
First Name & Middle Initial & Last Name & Degree
Alexandria Riopelle, MD
Phone
(617) 358-9700
Email
alexandria.riopelle@bmc.org
First Name & Middle Initial & Last Name & Degree
Anna Sutherland, MD
First Name & Middle Initial & Last Name & Degree
Alexandria Riopelle, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
5-Fluorouracil and Calcipotriene for Treatment of Low Grade Skin Cancer
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