Spots Global Cancer Trial Database for Multicenter Study of Hypofractionated Postoperative Radiotherapy in Patients Diagnosed With Prostate Carcinoma
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Trial Identification
Brief Title: Multicenter Study of Hypofractionated Postoperative Radiotherapy in Patients Diagnosed With Prostate Carcinoma
Official Title: Multicenter Study of Hypofractionated Postoperative Radiotherapy in Patients Diagnosed With Prostate Carcinoma
Study ID: NCT04484038
Conditions
Interventions
Study Description
Brief Summary: The objective of this study is to evaluate, in patients diagnosed with prostate cancer who undergo radical prostatectomy and who require postoperative radiotherapy, tolerance in terms of acute and chronic GU and GI toxicity and efficacy in terms of biochemical control and survival, as well as of quality of life, from a hypofractional external radiotherapy scheme, increasing the dose per fraction in a shorter period of time.
Detailed Description: What the investigators present in this study is a hypofractionation scheme of 62.5 Gy in 25 daily fractions of 2.5 Gy / day, which was chosen to provide a biological equivalent dose (BED) of 166.67 Gy, comparable to the 163 Gy administered with a scheme Normally divided up to 70 Gy in daily fractions of 2 Gy / day Version 2.0, March 27, 2019 (assuming an α / β ratio of 1.5 Gy for prostate cancer). The BED in risk organs (mainly rectum and bladder) will be governed by the ratio used and will differ depending on whether acute or late toxicity is calculated. If selected an acute α / β of 10 Gy and a conservative α / β for late toxicity of 3 Gy, the standard fractionation will result in an acute BED of 84 Gy versus 78 Gy in the hypofractionation scheme and a BED of 116.67 vs. 114.5 Gy for late toxicity. Therefore, what the investigators expect is a toxicity profile that is at least similar, if not slightly better, compared to the norm-fractionated scheme of 70 Gy in 35 fractions and similar rates of biochemical control and survival. To all this is added the use of intensity modulated radiotherapy and image-guided radiotherapy techniques (IGRT) that will allow the investigators to significantly reduce the dose administered to risk organs.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Hospital General Gregorio Marañón, Madrid, Adrid, Spain
Hospital Universitario de San Juan, San Juan, Alicante, Spain
ICO Badalona, Badalona, Barcelona, Spain
Hospital Dr. Negrin, Las Palmas de Gran Canaria, Gran Canaria, Spain
Hospital Universitario de Santiago, Santiago de Compostela, La Coruña, Spain
Hospital de Fuenlabrada, Fuenlabrada, Madrid, Spain
Hospital Universitario Torrecárdenas, Almería, , Spain
Hospital Universitario de Badajoz, Badajoz, , Spain
H. Sta. Cruz y San Pablo, Barcelona, , Spain
Instituto Oncológico IMQ, Bilbao, , Spain
Hospital Universitario San Cecilio, Granada, , Spain
Hospital Universitario Ramón Y Cajal, Madrid, , Spain
Fundación Jimenez Díaz 1, Madrid, , Spain
Fundación Jiménez Díaz 2, Madrid, , Spain
Hospital de La Princesa, Madrid, , Spain
Hospital La Luz, Madrid, , Spain
Hospital Quirón, Madrid, , Spain
Hospital Ruber Internacional, Madrid, , Spain
Complejo Hospitalario de Navarra, Pamplona, , Spain
Contact Details
Name: ASUNCION R HERVAS, I
Affiliation: Ramon y Cajal University Hospital
Role: PRINCIPAL_INVESTIGATOR
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