Patients Overexposed for a Prostate Adenocarcinoma

Prostate Adenocarcinoma Clinical Trial

— EPOPA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00773656
• Other study ID #: AOM 08234
• Status: Completed
• Phase: N/A
• First received: October 15, 2008
• Last updated: February 26, 2014
• Start date: October 2008
• Est. completion date: May 2013

Study information

• Verified date: February 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Adenocarcinoma
• Prostatic Neoplasms

Intervention

Other:
• Whole blood sample
70 ml per patient for collection of biological sample

Locations

Country	Name	City	State
France	Groupe Hospitalier Pitié-Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To correlate the received doses, the volume of irradiated normal tissues, the events, with biologic, phenotypic and genetic data.		At the inclusion visit	No
Secondary	Correlation between adverse events and radiation doses with biologic, phenotypic and genetic data.		At the inclusion visit	No
Secondary	Evaluation of T-lymphocyte apoptosis to predict radiation-induced late toxicity		At the inclusion visit	No
Secondary	Gene associations with risks for adverse events related to radiotherapy		At the inclusion visit	No
Secondary	Levels of circulating microparticles and bystander effect after irradiation		At the inclusion visit	No