Patients Overexposed for a Prostate Adenocarcinoma - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00773656

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

Drug Information available for: Epinephrine Epinephrine bitartrate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, 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

Biospecimen Description:

White cells, serum and DNA

Estimated Enrollment:	433
Study Start Date:	October 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 patients treated for a prostate adenocarcinoma	Other: Whole blood sample 80ml per patient for collection of biological 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

Contacts

Contact: Jean-Marc SIMON, MD

33 (0) 1 42 17 81 74

jean-marc.simon@psl.aphp.fr

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:

Alsbeih G, El-Sebaie M, Al-Harbi N, Al-Buhairi M, Al-Hadyan K, Al-Rajhi N. Radiosensitivity of human fibroblasts is associated with amino acid substitution variants in susceptible genes and correlates with the number of risk alleles. Int J Radiat Oncol Biol Phys. 2007 May 1;68(1):229-35. Epub 2007 Feb 27.

Responsible Party:	Department Clinical Research of Developpemnt ( Valerie Millul )
Study ID Numbers:	AOM 08234
Study First Received:	October 15, 2008
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00773656
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Radiotherapy
Biologically effective dose
Radiation injury

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Epinephrine
Genital Diseases, Male

Adenocarcinoma
Prostatic Neoplasms
Radiation Injuries
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 14, 2009