Study Stopped
Low rate of recruitment.
Hypofractionated Radiotherapy for Nonmelanoma Skin Cancer
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2011
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 3, 2014
CompletedFirst Posted
Study publicly available on registry
March 7, 2014
CompletedMarch 7, 2014
March 1, 2014
3.1 years
February 3, 2014
March 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Quality of Life
Second week and twelfth week after initiation of radiotherapy
Toxicity
Second week and twelfth week after initiation of radiotherapy
Study Arms (2)
30 Gy in 5 fractions of 6 Gy
EXPERIMENTALtumors ≤ 2 cm in diameter: 5 fractions of 600 cGy, once a day, five times a week - TDF: 89
40 Gy in 10 fractions of 4 Gy
EXPERIMENTALtumors \> 2-5 cm in diameter: 10 fractions of 400 cGy, once a day, five times a week - TDF: 96
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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..
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Barretos Cancer Hospital - Fundacao Pio XII
Barretos, São Paulo, 14784400, Brazil
Study Officials
- PRINCIPAL INVESTIGATOR
Ricardo A Nakamura, MD
Barretos Cancer Hospital - Fundação Pio XII
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2014
First Posted
March 7, 2014
Study Start
January 1, 2011
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
March 7, 2014
Record last verified: 2014-03