Hypofractionated Radiotherapy for Nonmelanoma Skin Cancer
NCT ID: NCT02080962
Last Updated: 2014-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
10 participants
INTERVENTIONAL
2011-01-31
2014-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Phase II Trial of SBRT Compared With Conventional Radiotherapy for Oligometastatic Non-Small Cell Lung Cancer
NCT02975609
Hypofractionated Radiotherapy (16/2) for the Palliation of Complicated Bone Metastases in Patients With KPS
NCT02376322
Hypofractionated Radiotherapy With Hyperthermia in Unresectable or Marginally Resectable Soft Tissue Sarcomas
NCT03989596
Radiotherapy With Hyperthermia in Recurrent and Radiation-Induced Sarcomas
NCT04398095
Phase II Trial of Carbon-ion Radiotherapy Combined With GM-CSF for the Treatment of Hepatocellular Carcinoma
NCT02946138
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
30 Gy in 5 fractions
5 fractions of 600 cGy, once a day, five times a week - TDF: 89
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
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
30 Gy in 5 fractions
5 fractions of 600 cGy, once a day, five times a week - TDF: 89
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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..
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Barretos Cancer Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ricardo A Nakamura, MD
Role: PRINCIPAL_INVESTIGATOR
Barretos Cancer Hospital - Fundação Pio XII
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Barretos Cancer Hospital - Fundacao Pio XII
Barretos, São Paulo, Brazil
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
399/2010
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.