Hypofractionated Radiotherapy for Nonmelanoma Skin Cancer

Study Overview
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Brief Summary
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Radiotherapy is a treatment considered standard for non melanoma skin cancer. This institution uses schemes of 4 to 6 weeks of treatment. The objective of the study is to perform radiation therapy in 1 to 2 weeks, depending on the size of the lesion.

Detailed Description
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Delineation of radiation field Gross tumor volume (GTV): disease clinically visible / palpable clinical target volume (CTV): equal to GTV planned treatment volume (PTV): tumors ≤ 2 cm in diameter, with 5-10 mm CTV margin tumors> 2-5 cm in diameter, with 15-20 mm CTV margin Marking the GTV and PTV pen back projection photograph of the treatment area protections of the normal structures with blocks of lead, if necessary Technical Distance focus-skin Tube: 35 cm Locator: 30 and 40 cm Sizes Tube: 2, 3 and 4 cm in diameter Finder: 6x8 cm, 8x10 cm Energy: 80 kV 140 kv Filter 80 kV, 2 mm Al 140 kv, 0.5 mm Copper Current Draw: 20 mA Dose tumors ≤ 2 cm in diameter: 5 fractions of 600 cGy, once a day, five times a week - TDF: 89 tumors > 2-5 cm in diameter: 10 fractions of 400 cGy, once a day, five times a week - TDF: 96 Clinical revisions every 5 weekly sessions, or a weekly and at the end of treatment.

Official Title
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Hypofractionated Radiotherapy for Nonmelanoma Skin Cancer: Study Phase II Clinical Trial

Conditions
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Non-melanoma Skin Cancer

Intervention / Treatment
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* Radiation: 30 Gy in 5 fractions
* Radiation: 40 Gy in 10 fractions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cosmesis not important Basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of any differentiation Clinical stage I and II Location on the thorax, abdomen, pelvis (except perineum), arm, thigh, cheek Patient with up to 3 injuries eligible for the study Karnofsky Performance Status (KPS) ≥ 70% Age > 18 years Informed Consent signed by the patient consenting to undergo the study Exclusion Criteria: Indian Race Prior treatment for their skin cancer More than three synchronous lesions to treatment with RT Basal syndrome, xeroderma, vitiligo and albinism Immunosuppression Prior burn at the tumor site Tumor > 5 cm Age <18 years Carrier mental incapacity People in a relationship of dependence as prisoners, soldiers, students, staff, etc..

Ages Eligible for Study
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Minimum Age: 18 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 30 Gy in 5 fractions of 6 Gy<br>tumors ≤ 2 cm in diameter: 5 fractions of 600 cGy, once a day, five times a week - TDF: 89 | Radiation: 30 Gy in 5 fractions<br>* 5 fractions of 600 cGy, once a day, five times a week - TDF: 89<br>* Other names: hypofractionated orthovoltage;|
| Experimental: 40 Gy in 10 fractions of 4 Gy<br>tumors > 2-5 cm in diameter: 10 fractions of 400 cGy, once a day, five times a week - TDF: 96 | Radiation: 40 Gy in 10 fractions<br>* tumors > 2-5 cm in diameter: 10 fractions of 400 cGy, once a day, five times a week - TDF: 96<br>* Other names: hypofractionated orthovoltage;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of complete remission with hypofractionated RT schemes for NMSC. | RECIST criteria Complete Response: disappearance of the lesion Partial Response: Reduction ≥ 30% of the larger initial diameter of the lesion Progressive Disease: ≥ 20% increase in the largest initial diameter of the lesion Stable disease: not increase enough to consider disease progression or reduction sufficient to consider a partial response. | Second week and twelfth week after initiation of radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | EORTC QLQ-C30 | Second week and twelfth week after initiation of radiotherapy | 
| Toxicity | Late Effects of Normal Tissue (LENT) SOMA Toxicity Grading and Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. | Second week and twelfth week after initiation of radiotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-melanoma skin cancer, radiotherapy, orthovoltage