Optimized 2D-RT for Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
2D radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring 2D, prostate neoplasms, radiotherapy, simulation
Eligibility Criteria
Inclusion Criteria:
- > 18 years
- clinical T stage: cT2b, cT2c, cT3a, cT3b
- informed consent
- MRI of the pelvis
Exclusion Criteria:
- > 79 years
- prior surgery treatment for prostate cancer
- prior pelvic radiotherapy
- genetic syndromes of hyper-radio-sensitivity
- chronic infiammatory bowel disease
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
2D radiotherapy
Arm Description
Patients with prostate cancer were treated with 2D-radiotherapy
Outcomes
Primary Outcome Measures
new indications for 2D fields definition
Twenty patients with prostate cancer (CAP) were identified. Pelvic MRI images were fused with CT-simulation images to delineate prostate and seminal vesicles on MRI images. Clinical Target Volume definition (CTV) was performed according to EORTC guidelines simulating 4 different categories: low-risk CAP, intermediate-risk CAP, high-risk CAP with or without involvement of the seminal vesicles. The Planning Target Volume (PTV) was defined by adding a margin of 10 mm to the CTV. For each patient, 8 treatment plans were calculated using box tecnhique: 2 treatment plans for each risk category were calculated by using a cobalt source or 10 MV photons. Progressive optimization was realized with an iterative procedure by evaluating the three-dimensional dose distribution. Once the final plan was achieved (respecting the PTV constraint: D98 > 95%), distances of the fields edges from a set of reference points were measured.
Secondary Outcome Measures
Full Information
NCT ID
NCT03339531
First Posted
November 3, 2017
Last Updated
March 12, 2018
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1. Study Identification
Unique Protocol Identification Number
NCT03339531
Brief Title
Optimized 2D-RT for Prostate Cancer
Official Title
Definition of Fields Margins for Optimized 2D Radiotherapy of Prostate Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
February 2, 2015 (Actual)
Primary Completion Date
December 18, 2015 (Actual)
Study Completion Date
December 18, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Prostate cancer (CAP) is one of the most common malignancies in men, both in Western countries and developing countries. Radiation therapy (RT) is an important therapeutic option. New technologies (3D, IMRT, IGRT, VMAT) have been introduced in the last decades, with a progressive improvement of clinical outcome. However, in many countries the only treatment option is the traditional 2D technique based on standard simulation. The indications for field definition in this treatment are still based on expert's opinions. The aim of this analysis is to propose new indications for 2D fields definition based on three-dimensional simulation in a population of patients with CAP. Twenty patients with CAP consecutively treated with RT in our center were identified. Patients underwent CT-simulation in supine position. Pelvic MRI images were fused with CT-simulation images. In this way, delineation of the prostate and seminal vesicles was performed on MRI images. Clinical Target Volume definition (CTV) was performed according to EORTC guidelines simulating 4 different categories: low-risk CAP, intermediate-risk CAP, high-risk CAP without involvement of the seminal vesicles, and high-risk CAP with involvement of seminal vesicles. The Planning Target Volume (PTV) was defined by adding a margin of 10 mm to the CTV in all directions. For each patient, 8 treatment plans were calculated. In particular, for each of the 4 categories of risk, 2 treatment plans were calculated by using a cobalt source or 10 MV photons. Treatment plans were calculated using the box technique. Progressive optimization was realized with an iterative procedure by evaluating the three-dimensional dose distribution. Once the final plan was achieved (respecting the PTV constraint: D98 > 95%), distances of the fields edges from a set of reference points were measured.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
2D, prostate neoplasms, radiotherapy, simulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2D radiotherapy
Arm Type
Experimental
Arm Description
Patients with prostate cancer were treated with 2D-radiotherapy
Intervention Type
Radiation
Intervention Name(s)
2D radiotherapy
Primary Outcome Measure Information:
Title
new indications for 2D fields definition
Description
Twenty patients with prostate cancer (CAP) were identified. Pelvic MRI images were fused with CT-simulation images to delineate prostate and seminal vesicles on MRI images. Clinical Target Volume definition (CTV) was performed according to EORTC guidelines simulating 4 different categories: low-risk CAP, intermediate-risk CAP, high-risk CAP with or without involvement of the seminal vesicles. The Planning Target Volume (PTV) was defined by adding a margin of 10 mm to the CTV. For each patient, 8 treatment plans were calculated using box tecnhique: 2 treatment plans for each risk category were calculated by using a cobalt source or 10 MV photons. Progressive optimization was realized with an iterative procedure by evaluating the three-dimensional dose distribution. Once the final plan was achieved (respecting the PTV constraint: D98 > 95%), distances of the fields edges from a set of reference points were measured.
Time Frame
through study completion, up to 10 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
> 18 years
clinical T stage: cT2b, cT2c, cT3a, cT3b
informed consent
MRI of the pelvis
Exclusion Criteria:
> 79 years
prior surgery treatment for prostate cancer
prior pelvic radiotherapy
genetic syndromes of hyper-radio-sensitivity
chronic infiammatory bowel disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessio G Morganti, MD
Organizational Affiliation
Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, Unversity of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
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Optimized 2D-RT for Prostate Cancer
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