Patients Overexposed for a Prostate Adenocarcinoma (EPOPA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00773656
First received: October 15, 2008
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

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).


Condition Intervention
Prostate Adenocarcinoma
Other: Whole blood sample

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official 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

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation between adverse events and radiation doses with biologic, phenotypic and genetic data. [ Time Frame: At the inclusion visit ] [ Designated as safety issue: No ]
  • Evaluation of T-lymphocyte apoptosis to predict radiation-induced late toxicity [ Time Frame: At the inclusion visit ] [ Designated as safety issue: No ]
  • Gene associations with risks for adverse events related to radiotherapy [ Time Frame: At the inclusion visit ] [ Designated as safety issue: No ]
  • Levels of circulating microparticles and bystander effect after irradiation [ Time Frame: At the inclusion visit ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

White cells, serum and DNA


Enrollment: 249
Study Start Date: October 2008
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
patients treated for a prostate adenocarcinoma
Other: Whole blood sample
70 ml per patient for collection of biological sample
Other Name: Whole blood sample

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Consecutive patients treated for a prostate adenocarcinoma in the radiation department of the Jean MONNET Hospital between 2000 and 2006.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00773656

Locations
France
Groupe Hospitalier Pitié-Salpêtrière
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Jean Marc SIMON, PH Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00773656     History of Changes
Other Study ID Numbers: AOM 08234
Study First Received: October 15, 2008
Last Updated: February 26, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Radiotherapy
Biologically effective dose
Radiation injury

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 16, 2014