Hypofractionated Radiotherapy for Nonmelanoma Skin Cancer: Study Phase II Clinical Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Non-melanoma Skin Cancer
- Sponsor
- Barretos Cancer Hospital
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Rate of complete remission with hypofractionated RT schemes for NMSC.
- Status
- Terminated
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
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..
Outcomes
Primary Outcomes
Rate of complete remission with hypofractionated RT schemes for NMSC.
Time Frame: 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 Outcomes
- Quality of Life(Second week and twelfth week after initiation of radiotherapy)
- Toxicity(Second week and twelfth week after initiation of radiotherapy)