Tumour and HEalthy Tissues DOse-response and Radiosensitivity Assay (THEODORA)
|ClinicalTrials.gov Identifier: NCT02797405|
Recruitment Status : Terminated (Withdrawal of analysis study Partner.)
First Posted : June 13, 2016
Last Update Posted : March 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma Rectal Carcinoma Esophagus Cancer||Radiation: Standard treatment||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||97 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Individual Radiosensitivity of Cancer Patients to be Treated by Radiotherapy or Radiochemotherapy Per-operative|
|Study Start Date :||October 2016|
|Actual Primary Completion Date :||August 13, 2019|
|Actual Study Completion Date :||March 13, 2020|
The patients will receive standard treatment according to international recommendations depending on their type of cancer.
Radiation: Standard treatment
Sarcoma patients will undergo radiotherapy followed by surgery Rectum cancer patients will undergo radio-chemotherapy followed by surgery Esophagus cancer patients will undergo radio-chemotherapy followed by surgery
- Calibration of the correlation between the clinical tumor response and the results of A/MS bioassays using tumor samples [ Time Frame: 2.5 years (after 100 patients enrolled ) ]The calibration stage will be performed using data from the first 40 patients enrolled. All the potential correlations between the clinical and radiobiological parameters will be tested. The links between clinical tumor response parameters and radiobiological parameters derived from MS/A bioassays using tumor samples.
- Validation of the correlation between the clinical tumor response and the results of A/MS bioassays using tumor samples [ Time Frame: 2.5 years (after 100 patients enrolled ) ]The validation stage will be performed using data from the remaining 60 patients enrolled. This stage will assess whether or not the prediction of tumor response derived from the A/MS bioassays fits with the observed tumor response after RT.
- Validation of the correlation between the healthy tissue response (i.e. AE reported as per CTCAE v4) and the results of MS/A bioassays using skin biopsies [ Time Frame: 2.5 years (after 100 patients enrolled ) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797405
|Centre Francois Baclesse|
|Caluire-et-Cuire, France, 69641|
|Centre Georges-François Leclerc|
|Dijon, France, 21079|
|Centre Léon Bérard|
|Lyon, France, 69008|
|Hôpital Privé Jean Mermoz|
|Lyon, France, 69008|
|ICL - Institut de Cancérologie de la Lorraine|
|Vandœuvre-lès-Nancy, France, 54519|
|Hopital Nord Ouest Villefranche Sur Saone|
|Principal Investigator:||Marie-Pierre SUNYACH, MD||Centre Leon Berard|