Tumour and HEalthy Tissues DOse-response and Radiosensitivity Assay

Study Overview
=================
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.

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

Conditions
-----------------
Sarcoma, Rectal Carcinoma, Esophagus Cancer

Intervention / Treatment
-----------------
* Radiation: Standard treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: I1. Patients (male or female) ≥ 18 years of age. I2. Adult patients with a suspected, non-treated, non-metastatic retroperitoneal or limb soft tissue sarcoma, esophagus cancer or rectum cancer to be treated by pre-operative radiotherapy or radio-chemotherapy I3. At least one measurable lesion as per RECIST 1.1 I4. Documented negative serology tests (HVB, HIV, HVC) I5. PS ECOG 0 to 1 I6. Patient able and willing to provide informed consent. I7. Ability to understand and willingness for follow-up visits. I8. Covered by a medical insurance. Exclusion Criteria: E1. Contra-indication to radiotherapy E2. Contra-indication to skin biopsy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard treatment<br>The patients will receive standard treatment according to international recommendations depending on their type of cancer. | Radiation: Standard treatment<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calibration of the correlation between the clinical tumor response and the results of A/MS bioassays using tumor samples | 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. | 2.5 years (after 100 patients enrolled ) | 
| Validation of the correlation between the clinical tumor response and the results of A/MS 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. | 2.5 years (after 100 patients enrolled ) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 2.5 years (after 100 patients enrolled ) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radiation therapy, radiosensitivity, in vitro diagnostic medical devices, Adverse Event post radiotherapy