Hypofractionated Radiotherapy for Nonmelanoma Skin Cancer
Primary Purpose
Non-melanoma Skin Cancer
Status
Terminated
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
30 Gy in 5 fractions
40 Gy in 10 fractions
Sponsored by
About this trial
This is an interventional treatment trial for Non-melanoma Skin Cancer focused on measuring non-melanoma skin cancer, radiotherapy, orthovoltage
Eligibility 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..
Sites / Locations
- Barretos Cancer Hospital - Fundacao Pio XII
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
30 Gy in 5 fractions of 6 Gy
40 Gy in 10 fractions of 4 Gy
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Quality of Life
EORTC QLQ-C30
Toxicity
Late Effects of Normal Tissue (LENT) SOMA Toxicity Grading and Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Full Information
NCT ID
NCT02080962
First Posted
February 3, 2014
Last Updated
March 5, 2014
Sponsor
Barretos Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02080962
Brief Title
Hypofractionated Radiotherapy for Nonmelanoma Skin Cancer
Official Title
Hypofractionated Radiotherapy for Nonmelanoma Skin Cancer: Study Phase II Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Terminated
Why Stopped
Low rate of recruitment.
Study Start Date
January 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barretos Cancer Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-melanoma Skin Cancer
Keywords
non-melanoma skin cancer, radiotherapy, orthovoltage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
30 Gy in 5 fractions of 6 Gy
Arm Type
Experimental
Arm Description
tumors ≤ 2 cm in diameter: 5 fractions of 600 cGy, once a day, five times a week - TDF: 89
Arm Title
40 Gy in 10 fractions of 4 Gy
Arm Type
Experimental
Arm Description
tumors > 2-5 cm in diameter: 10 fractions of 400 cGy, once a day, five times a week - TDF: 96
Intervention Type
Radiation
Intervention Name(s)
30 Gy in 5 fractions
Other Intervention Name(s)
hypofractionated orthovoltage
Intervention Description
5 fractions of 600 cGy, once a day, five times a week - TDF: 89
Intervention Type
Radiation
Intervention Name(s)
40 Gy in 10 fractions
Other Intervention Name(s)
hypofractionated orthovoltage
Intervention Description
tumors > 2-5 cm in diameter: 10 fractions of 400 cGy, once a day, five times a week - TDF: 96
Primary Outcome Measure Information:
Title
Rate of complete remission with hypofractionated RT schemes for NMSC.
Description
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.
Time Frame
Second week and twelfth week after initiation of radiotherapy
Secondary Outcome Measure Information:
Title
Quality of Life
Description
EORTC QLQ-C30
Time Frame
Second week and twelfth week after initiation of radiotherapy
Title
Toxicity
Description
Late Effects of Normal Tissue (LENT) SOMA Toxicity Grading and Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Time Frame
Second week and twelfth week after initiation of radiotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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..
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo A Nakamura, MD
Organizational Affiliation
Barretos Cancer Hospital - Fundação Pio XII
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barretos Cancer Hospital - Fundacao Pio XII
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14784400
Country
Brazil
12. IPD Sharing Statement
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Hypofractionated Radiotherapy for Nonmelanoma Skin Cancer
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