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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02080962
Other study ID # 399/2010
Secondary ID
Status Terminated
Phase Phase 2
First received February 3, 2014
Last updated March 5, 2014
Start date January 2011
Est. completion date February 2014

Study information

Verified date March 2014
Source Barretos Cancer Hospital
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Terminated
Enrollment 10
Est. completion date February 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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..

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Radiation:
30 Gy in 5 fractions
5 fractions of 600 cGy, once a day, five times a week - TDF: 89
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

Locations

Country Name City State
Brazil Barretos Cancer Hospital - Fundacao Pio XII Barretos Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
Barretos Cancer Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Second week and twelfth week after initiation of radiotherapy Yes
Secondary Quality of Life EORTC QLQ-C30 Second week and twelfth week after initiation of radiotherapy No
Secondary Toxicity Late Effects of Normal Tissue (LENT) SOMA Toxicity Grading and Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Second week and twelfth week after initiation of radiotherapy Yes
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