Trial Comparing Intensity Modulated Radiotherapy Versus Conformal Radiotherapy to Treat Prostate Cancer With Hypofractionated Schedule
NCT ID: NCT02257827
Last Updated: 2014-10-06
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
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COMPLETED
PHASE3
220 participants
INTERVENTIONAL
2009-01-31
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IMRT- Hypofractionated schedule 70 Gy/25 fx
The IMRT plan consisted of five - seven fields to deliver the same dose prescribed at the isodose line covering 95% of PTV.By the linear-quadratic formula, considering an α/β ratio of 1.5 Gy for prostate cancer, 70 Gy/25 fractions is equivalent to 86 Gy in 43 fractions of 2 Gy. All patients were simulated on CT simulator.
IMRT
The IMRT plan consisted of five - seven fields to deliver the same dose prescribed at the isodose line covering 95% of PTV.
The 3DCRT plan consisted of six fields to deliver a total dose of 70 Gy/ 25 fractions of a single daily dose of 2.8 Gy.
3DCRT-Hypofractionated schedule 70 Gy/25 fx
The 3DCRT plan consisted of six fields to deliver a total dose of 70 Gy/ 25 fractions of a single daily dose of 2.8 Gy. By the linear-quadratic formula, considering an α/β ratio of 1.5 Gy for prostate cancer, 70 Gy/25 fractions is equivalent to 86 Gy in 43 fractions of 2 Gy. All patients were simulated on CT simulator.
IMRT
The IMRT plan consisted of five - seven fields to deliver the same dose prescribed at the isodose line covering 95% of PTV.
The 3DCRT plan consisted of six fields to deliver a total dose of 70 Gy/ 25 fractions of a single daily dose of 2.8 Gy.
Interventions
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IMRT
The IMRT plan consisted of five - seven fields to deliver the same dose prescribed at the isodose line covering 95% of PTV.
The 3DCRT plan consisted of six fields to deliver a total dose of 70 Gy/ 25 fractions of a single daily dose of 2.8 Gy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* With age between 18-75 years classified in low
* Intermediate and high-risk group according to their Gleason score
* T stage and initial PSA (iPSA).
* Low risk group included patients with Gleason score \<7 / stage T1-T2a, and iPSA \<10 ng/mL.
* Intermediate risk included Gleason score \< 7, or Stage T1-T2b, or iPSA level of 10-20 ng/mL
* High-risk patients with Gleason score \>7, or Stage \> T2b, or iPSA \>20 ng/mL.
* All patients classified as high risk was submitted to the bone scans.
Exclusion Criteria
* Prior history of prostatectomy
* Pelvic radiotherapy treatment
* Chemotherapy treatment were excluded of this trial.
18 Years
75 Years
MALE
No
Sponsors
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Gustavo Viani Arruda
OTHER
Responsible Party
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Gustavo Viani Arruda
Gustavo Arruda Viani, M.D, Phd.
Principal Investigators
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Gustavo Viani, PhD
Role: PRINCIPAL_INVESTIGATOR
FAMEMA
Locations
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Faculty of Medicine of Marilia
Marília, São Paulo, Brazil
Countries
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Other Identifiers
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FAMEMA-0913
Identifier Type: -
Identifier Source: org_study_id
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