Hypofractionated Radiotherapy for Nonmelanoma Skin Cancer
- Conditions
- Non-melanoma Skin Cancer
- Interventions
- Radiation: 30 Gy in 5 fractionsRadiation: 40 Gy in 10 fractions
- Registration Number
- NCT02080962
- Lead Sponsor
- Barretos Cancer Hospital
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
- 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
- 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..
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 30 Gy in 5 fractions of 6 Gy 30 Gy in 5 fractions tumors ≤ 2 cm in diameter: 5 fractions of 600 cGy, once a day, five times a week - TDF: 89 40 Gy in 10 fractions of 4 Gy 40 Gy in 10 fractions tumors \> 2-5 cm in diameter: 10 fractions of 400 cGy, once a day, five times a week - TDF: 96
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Barretos Cancer Hospital - Fundacao Pio XII
🇧🇷Barretos, Sao Paulo, Brazil