Non-melanoma Skin Cancer
Conditions
Keywords
non-melanoma skin cancer, radiotherapy, orthovoltage
Brief summary
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
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.
Interventions
RADIATION30 Gy in 5 fractions
5 fractions of 600 cGy, once a day, five times a week - TDF: 89
RADIATION40 Gy in 10 fractions
tumors \> 2-5 cm in diameter: 10 fractions of 400 cGy, once a day, five times a week - TDF: 96
Sponsors
Barretos Cancer Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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..
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of complete remission with hypofractionated RT schemes for NMSC. | Second week and twelfth week after initiation of radiotherapy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | Second week and twelfth week after initiation of radiotherapy | EORTC QLQ-C30 |
| Toxicity | Second week and twelfth week after initiation of radiotherapy | Late Effects of Normal Tissue (LENT) SOMA Toxicity Grading and Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. |
Countries
Brazil
Outcome results
None listed