Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Sarcoma

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Soft Tissue Sarcoma

The patients will receive standard treatment according to international recommendations depending on their type of cancer.

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

Standard treatment

Marie-Pierre SUNYACH, MD

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.

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.

Tumour and HEalthy Tissues DOse-response and Radiosensitivity Assay

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

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Tumour and HEalthy Tissues DOse-response and Radiosensitivity Assay	NCT02797405	Sarcoma Rectal Carcinom... Esophagus Cance...	Standard treatm...	18 Years -	Centre Leon Berard
Tumour and HEalthy Tissues DOse-response and Radiosensitivity Assay	NCT02797405	Sarcoma Rectal Carcinom... Esophagus Cance...	Standard treatm...	18 Years -	Centre Leon Berard

Spots Global Cancer Trial Database for adverse event post radiotherapy