Prostate CancerNCT02974231
Intensity-modulated Radiation Therapy From 70Gy to 80Gy in Localized Prostate Cancer
An observational study of Prostate Cancer, run by Institut de Cancérologie de Lorraine.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Intensity-modulated radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients records would be extracted from the electronic health record system of Institut de Cancérologie de Lorraine
Who may be able to join
- 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
Who cannot join
- Patients with positive pelvic lymphadenectomy or radiological positives nodes
About this study
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)
- Conditions
- Prostate Cancer
- Being tested
- Intensity-modulated radiation therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity-modulated radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
grade≥ 2 overall late rectal 5 years after the end of radiotherapy
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2016 (estimated)
- Study startDec 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974231
- Sponsor's protocol ID
- ICL_2014_0002
- Status last verified
- Oct 2016
- First submitted
- 10 Oct 2016
- Last updated
- 28 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensity-modulated Radiation Therapy From 70Gy to 80Gy in Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT02974231
- Acronym / sponsor ID
- ICL_2014_0002
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 28 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients records would be extracted from the electronic health record system of Institut de Cancérologie de Lorraine
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with positive pelvic lymphadenectomy or radiological positives nodes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensity-modulated radiation therapy | Radiation | – |
Primary outcome
grade≥ 2 overall late rectal 5 years after the end of radiotherapy
Time frame: 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Institut de Cancérologie de Lorraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
grade≥ 2 overall late rectal 5 years after the end of radiotherapy (time frame: 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2016; AzTrials last refreshed its copy on 8 Nov 2026.