Clinical trial NCT02080962: Hypofractionated Radiotherapy for Nonmelanoma Skin Cancer
Official title: Hypofractionated Radiotherapy for Nonmelanoma Skin Cancer: Study Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-melanoma Skin Cancer
Keywords: non-melanoma skin cancer, radiotherapy, orthovoltage
Lead sponsor: Barretos Cancer Hospital
Sponsor class: OTHER
First posted: 2014-03-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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..

Primary outcomes:
measure: Rate of complete remission with hypofractionated RT schemes for NMSC.
timeFrame: Second week and twelfth week after initiation of radiotherapy
Secondary outcomes:
measure: Quality of Life
timeFrame: Second week and twelfth week after initiation of radiotherapy
measure: Toxicity
timeFrame: Second week and twelfth week after initiation of radiotherapy
Other outcomes:
Locations:
city: Barretos
country: Brazil
facility: Barretos Cancer Hospital - Fundacao Pio XII
state: Sao Paulo
Study officials:
affiliation: Barretos Cancer Hospital - Fundação Pio XII
name: Ricardo A Nakamura, MD
role: PRINCIPAL_INVESTIGATOR
References: