Hypofractionated Radiotherapy for Nonmelanoma Skin Cancer

Non-melanoma Skin Cancer Clinical Trial

Official title:

Hypofractionated Radiotherapy for Nonmelanoma Skin Cancer: Study Phase II Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02080962
• Other study ID #: 399/2010
• 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

• Non-melanoma Skin Cancer
• Skin Neoplasms

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