Hypofractionated Radiotherapy for Nonmelanoma Skin Cancer

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

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.

Study Overview

• Status: Terminated
• Conditions: Non-melanoma Skin Cancer
• Intervention / Treatment: Radiation: 30 Gy in 5 fractions; Radiation: 40 Gy in 10 fractions

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • Barretos, Sao Paulo, Brazil, 14784400
      • Barretos Cancer Hospital - Fundação Pio XII

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 30 Gy in 5 fractions of 6 Gy; 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; 5 fractions of 600 cGy, once a day, five times a week - TDF: 89; Other Names: hypofractionated orthovoltage
Experimental: 40 Gy in 10 fractions of 4 Gy; 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; tumors > 2-5 cm in diameter: 10 fractions of 400 cGy, once a day, five times a week - TDF: 96; Other Names: hypofractionated orthovoltage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	EORTC QLQ-C30	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.	Second week and twelfth week after initiation of radiotherapy

Collaborators and Investigators

• Sponsor: Barretos Cancer Hospital
• Investigators: Principal Investigator: Ricardo A Nakamura, MD, Barretos Cancer Hospital - Fundação Pio XII

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: February 3, 2014
• First Submitted That Met QC Criteria: March 5, 2014
• First Posted (Estimate): March 7, 2014

Study Record Updates

• Last Update Posted (Estimate): March 7, 2014
• Last Update Submitted That Met QC Criteria: March 5, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: non-melanoma skin cancer, radiotherapy, orthovoltage
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Skin Neoplasms
• Other Study ID Numbers: 399/2010