- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02974231
Intensity-modulated Radiation Therapy From 70Gy to 80Gy in Localized Prostate Cancer
November 25, 2016 updated by: Institut de Cancérologie de Lorraine
The objective is to report outcomes,including grade ≥2 overall late rectal and urinary toxicity and biochemical control rates in patients treated with IMRT (70 gy, 74 Gy and 80 Gy)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
240
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Patients records would be extracted from the electronic health record system of Institut de Cancérologie de Lorraine
Description
Inclusion Criteria:
Consecutive patients from June 2000 to December 2010 with
- untreated histologically confirmed adenocarcinoma of the prostate
- stage T1c-T4 N0 M0 according to the 1992 American Joint Committee on Cancer staging system
Exclusion Criteria:
- Patients with positive pelvic lymphadenectomy or radiological positives nodes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
grade≥ 2 overall late rectal 5 years after the end of radiotherapy
Time Frame: 60 months
|
60 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
October 10, 2016
First Submitted That Met QC Criteria
November 25, 2016
First Posted (Estimate)
November 28, 2016
Study Record Updates
Last Update Posted (Estimate)
November 28, 2016
Last Update Submitted That Met QC Criteria
November 25, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICL_2014_0002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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