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Patients Overexposed for a Prostate Adenocarcinoma

NCT00773656 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 249

Last updated 2014-02-27

No results posted yet for this study

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).

Conditions

  • Prostate Adenocarcinoma

Interventions

OTHER

Whole blood sample

70 ml per patient for collection of biological sample

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Jean Marc SIMON, PH · Assistance Publique - Hôpitaux de Paris

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00773656 on ClinicalTrials.gov