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Patients Overexposed for a Prostate Adenocarcinoma

Surveillance of the Cohort of Patients Overexposed in a Course of Conformational Radiotherapy for a Prostate Adenocarcinoma in Jean MONNET Hospital, Epinal, France. Epinal: Patients Overexposed for a Prostate Adenocarcinoma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00773656
Acronym
EPOPA
Enrollment
249
Registered
2008-10-16
Start date
2008-10-31
Completion date
2013-05-31
Last updated
2014-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Adenocarcinoma

Keywords

Radiotherapy, Biologically effective dose, Radiation injury

Brief summary

Background: Between 2000 and 2006, 433 patients were overexposed (8% to 10%) during a course of conformal radiotherapy for a prostate adenocarcinoma in Jean MONNET hospital, Epinal, France. Among them, twenty four patients received an additional mean dose about 20%, due to an inappropriate use of the treatment planning system. Severe adverse events (proctitis, cystitis, and tissue necrosis) have occurred among most of these overexposed patients. We propose to develop several research programs in order to increase the scientific knowledge on iatrogenic effects related to overexposure of ionizing radiation, by studying their relationship with dosimetric, clinical, biologic and genetic characteristics. Aim of the study: To correlate the received doses, the volume of irradiated normal tissues, the events, with biologic, phenotypic and genetic data. Primary study endpoint: Incidence and severity of adverse events related to radiotherapy (according to SOMA - LENT and CTCAE scales).

Detailed description

Secondary study endpoint: * Correlation between adverse events and radiation doses with biologic, phenotypic and genetic data. * Evaluation of T-lymphocyte apoptosis to predict radiation-induced late toxicity * Gene associations with risks for adverse events related to radiotherapy * Levels of circulating microparticles and bystander effect after irradiation Inclusion criteria: Consecutive patients treated for a prostate adenocarcinoma in the radiation department of the Jean MONNET Hospital between 2000 and 2006. Potential. Better identification of patients at high risk of adverse events related to radiotherapy.

Interventions

70 ml per patient for collection of biological sample

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* provision of informed consent * patient treated for prostate adenocarcinoma and overexposed during radiotherapy in a prostate adenocarcinoma in the radiation department of the a prostate adenocarcinoma in the radiation department of the Jean MONNET hospital/ service de radiotherapies between 2000 and 2006

Exclusion criteria

* No provision of informed consent * Patient with disease worsening and in incapacity to move about to CHJM

Design outcomes

Primary

MeasureTime frame
To correlate the received doses, the volume of irradiated normal tissues, the events, with biologic, phenotypic and genetic data.At the inclusion visit

Secondary

MeasureTime frame
Correlation between adverse events and radiation doses with biologic, phenotypic and genetic data.At the inclusion visit
Evaluation of T-lymphocyte apoptosis to predict radiation-induced late toxicityAt the inclusion visit
Gene associations with risks for adverse events related to radiotherapyAt the inclusion visit
Levels of circulating microparticles and bystander effect after irradiationAt the inclusion visit

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026