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Tumour and HEalthy Tissues DOse-response and Radiosensitivity Assay — THEODORA  

Sarcoma Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02797405
Study type Interventional
Source Centre Leon Berard
Contact
Status Terminated
Phase N/A
Start date October 2016
Completion date March 13, 2020
View Details
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