Hypofractionated Radiotherapy for Nonmelanoma Skin Cancer

This study has been terminated.
(Low rate of recruitment.)
Sponsor:
Information provided by (Responsible Party):
Barretos Cancer Hospital
ClinicalTrials.gov Identifier:
NCT02080962
First received: February 3, 2014
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Non-melanoma Skin Cancer
Radiation: 30 Gy in 5 fractions
Radiation: 40 Gy in 10 fractions
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hypofractionated Radiotherapy for Nonmelanoma Skin Cancer: Study Phase II Clinical Trial

Resource links provided by NLM:


Further study details as provided by Barretos Cancer Hospital:

Primary Outcome Measures:
  • Rate of complete remission with hypofractionated RT schemes for NMSC. [ Time Frame: Second week and twelfth week after initiation of radiotherapy ] [ Designated as safety issue: Yes ]

    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 Outcome Measures:
  • Quality of Life [ Time Frame: Second week and twelfth week after initiation of radiotherapy ] [ Designated as safety issue: No ]
    EORTC QLQ-C30

  • Toxicity [ Time Frame: Second week and twelfth week after initiation of radiotherapy ] [ Designated as safety issue: Yes ]
    Late Effects of Normal Tissue (LENT) SOMA Toxicity Grading and Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.


Enrollment: 10
Study Start Date: January 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: hypofractionated orthovoltage

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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..
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02080962

Locations
Brazil
Barretos Cancer Hospital - Fundacao Pio XII
Barretos, Sao Paulo, Brazil, 14784400
Sponsors and Collaborators
Barretos Cancer Hospital
Investigators
Principal Investigator: Ricardo A Nakamura, MD Barretos Cancer Hospital - Fundação Pio XII
  More Information

No publications provided

Responsible Party: Barretos Cancer Hospital
ClinicalTrials.gov Identifier: NCT02080962     History of Changes
Other Study ID Numbers: 399/2010
Study First Received: February 3, 2014
Last Updated: March 5, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Barretos Cancer Hospital:
non-melanoma skin cancer, radiotherapy, orthovoltage

Additional relevant MeSH terms:
Skin Neoplasms
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 21, 2014