Intralesional Versus Intramuscular Methotrexate for Non-melanoma Skin Cancers

Study Overview
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Brief Summary
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to compare the effectiveness and safety of intralesional vs. systemic MTX in NMSC management

Detailed Description
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Intralesional methotrexate (MTX) could to be promising conservative alternative for non-melanoma skin cancer (NMSC). Systemic MTX was attempted as adjuvant for locally-advanced NMSC.

Official Title
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Intralesional Methotrexate Versus Intramuscular Methotrexate in the Treatment of Non-melanoma Skin Cancers

Conditions
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Non-melanoma Skin Cancers

Intervention / Treatment
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* Drug: Methotrexate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Adult patients of both sexes with histologically-confirmed primary or recurrent non- metastatic NMSCs of different types (BCC,SCC, and/or KA), sites, number, sizes and duration were included in the study. Exclusion Criteria: • Hypersensitivity reactions to methotrexate, liver or kidney disease, immunosuppressive conditions, HIV, HBV, and HCV infection, hematological abnormalities and metastasis. Pregnant or lactating women, females in their child-bearing period not using or refusing contraceptive methods, and those who had any other form of NMSC management in the month preceding enrollment.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intralesional methotrexate<br>Group A 30 patients received intralesional injection of MTX with an insulin syringe into the tumor at a dose ranging between 12.5 mg to 25 mg according to the tumor size every week until complete improvement or for a maximum of 8 sessions. | Drug: Methotrexate<br>* A randomized comparative effectiveness clinical trial<br>|
| Active Comparator: Intramuscular methotrexate<br>Group B 30 patients received systemic MTX (SC, or IM) was injected at a dose of 25 mg every week until clearance or for a maximum of 8 sessions. | Drug: Methotrexate<br>* A randomized comparative effectiveness clinical trial<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in size and number of tumors | Patients were divided into 3 groups: responders (if the tumor has regressed by > 50%), partial responders (tumor regression < 50%), and non- responders (no improvement at all or worsening). | up to 1 month after the last session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects |  | Starting from the first session and up to 6-months after the last session | 
| Recurrence | after achieving response greater than 50% of the tumor | till the end of follow up duration (6 months) | 
| New NMSC lesions elsewhere |  | from the start of the study and till the end of follow up period (6 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-melanoma skin cancer, Intralesional methotrexate, Systemic methotrexate, Intramuscular methotrexate, Keratoacanthoma, Basal cell carcinoma, Squamous cell carcinoma