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Spots Global Cancer Trial Database for Tumour and HEalthy Tissues DOse-response and Radiosensitivity Assay

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Trial Identification

Brief Title: Tumour and HEalthy Tissues DOse-response and Radiosensitivity Assay

Official Title: Evaluation of Individual Radiosensitivity of Cancer Patients to be Treated by Radiotherapy or Radiochemotherapy Per-operative

Study ID: NCT02797405

Interventions

Standard treatment

Study Description

Brief Summary: THEODORA is a prospective pilot clinical trial aiming at first to evaluate and validate the predictive value of the A \& MS bioassays on tumor control by radiotherapy.

Detailed Description: For that purpose, this project is composed of 3 stages: * A Calibration stage that will allow to evaluate the correlation between the clinical tumor response parameters (i.e. TV/AP features) and the radiobiological parameters issued from the A/MS bioassays in order to develop a mathematic model defining the UTCR parameter * A Validation stage in order to assess the validity of A/MS bioassays towards clinical tumour response parameters (i.e. both TV/AP features and UTCR). * A Precision stage will be performed either to improve the precision of the predictive performance of the A and MS bioassays or to establish a new mathematical model describing the correlation between clinical and radiobiological parameters. The objective of this precision stage will depend of the results of the calibration stage (see below). This prospective clinical study will be conducted in a population of patients with different tumor types in order to explore a large range of tumor radiosensitivity including sarcomas, rectal carcinoma and esophagus tumor.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Centre Francois Baclesse, Caen, , France

Infirmerie Protestante, Caluire-et-Cuire, , France

Centre Georges-François Leclerc, Dijon, , France

Centre Léon Bérard, Lyon, , France

Hôpital Privé Jean Mermoz, Lyon, , France

ICL - Institut de Cancérologie de la Lorraine, Vandœuvre-lès-Nancy, , France

Hopital Nord Ouest Villefranche Sur Saone, Villefranche-sur-Saône, , France

Contact Details

Name: Marie-Pierre SUNYACH, MD

Affiliation: Centre Leon Berard

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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