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OpenTrials
Completed

NCT Number: NCT00773656

Patients Overexposed for a Prostate Adenocarcinoma

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).

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Key information

Conditions

Prostate Adenocarcinoma Radiation Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Groupe Hospitalier Pitié-Salpêtrière

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

whole blood sample

Other

70 ml per patient for collection of biological sample

Primary outcomes

  1. To correlate the received doses, the volume of irradiated normal tissues, the events, with biologic, phenotypic and genetic data.

    Time frame: At the inclusion visit

Secondary outcomes

  1. Correlation between adverse events and radiation doses with biologic, phenotypic and genetic data.

    Time frame: At the inclusion visit

  2. Evaluation of T-lymphocyte apoptosis to predict radiation-induced late toxicity

    Time frame: At the inclusion visit

  3. Gene associations with risks for adverse events related to radiotherapy

    Time frame: At the inclusion visit

  4. Levels of circulating microparticles and bystander effect after irradiation

    Time frame: At the inclusion visit

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: EPOPA

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Oct 16, 2008
Registry last updated
Feb 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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