Hypofractionated Radiotherapy for Nonmelanoma Skin Cancer

Barretos Cancer Hospital

Status and phase: Terminated; Phase 2

Conditions: Non-melanoma Skin Cancer

Treatments: Radiation: 40 Gy in 10 fractions; Radiation: 30 Gy in 5 fractions

Study type: Interventional

Funder types: Other

Identifiers

NCT02080962

399/2010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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..

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

30 Gy in 5 fractions of 6 Gy

Experimental group

Description:

tumors ≤ 2 cm in diameter: 5 fractions of 600 cGy, once a day, five times a week - TDF: 89

Treatment:

Radiation: 30 Gy in 5 fractions

40 Gy in 10 fractions of 4 Gy

Experimental group

Description:

tumors \> 2-5 cm in diameter: 10 fractions of 400 cGy, once a day, five times a week - TDF: 96

Treatment:

Radiation: 40 Gy in 10 fractions