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Clinical Trials/NCT02080962
NCT02080962TerminatedPhase 2

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

Barretos Cancer Hospital2 sites in 1 country10 target enrollmentStarted: January 1, 2011Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Terminated
Sponsor
Enrollment
10
Locations
2
Primary Endpoint
Rate of complete remission with hypofractionated RT schemes for NMSC.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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..

Outcomes

Primary Outcomes

Rate of complete remission with hypofractionated RT schemes for NMSC.

Time Frame: Second week and twelfth week after initiation of radiotherapy

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.

Secondary Outcomes

  • Quality of Life(Second week and twelfth week after initiation of radiotherapy)
  • Toxicity(Second week and twelfth week after initiation of radiotherapy)

Investigators

Sponsor
Barretos Cancer Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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