A Phase 2 interventional study of 30 Gy in 5 fractions and 40 Gy in 10 fractions in Non-melanoma Skin Cancer, sponsored by Barretos Cancer Hospital. Terminated at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-03-07.
Sponsored by Barretos Cancer Hospital · Phase 2, Interventional, and Treatment
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.
Delineation of radiation field
Technical
Energy:
80 kV 140 kv
Dose
Clinical revisions every 5 weekly sessions, or a weekly and at the end of treatment.
582 studies on the registry are indexed under Skin Neoplasms; 114 are open to participants now.
This study's enrollment of 10 is below the median of 53 across 416 interventional studies indexed under Skin Neoplasms.
Browse Skin Neoplasms studies →Barretos Cancer Hospital is the lead sponsor of 48 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
5 fractions of 600 cGy, once a day, five times a week - TDF: 89
Also known as: hypofractionated orthovoltage
tumors \> 2-5 cm in diameter: 10 fractions of 400 cGy, once a day, five times a week - TDF: 96
Also known as: hypofractionated orthovoltage
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.
Time frame: Second week and twelfth week after initiation of radiotherapy
Quality of Life
EORTC QLQ-C30
Time frame: 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.
Time frame: Second week and twelfth week after initiation of radiotherapy
This study is terminated, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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Barretos Cancer Hospital