Tumour and HEalthy Tissues DOse-response and Radiosensitivity Assay

Centre Leon Berard97 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Sarcoma Rectal Carcinoma Esophagus Cancer

Interventions

Standard treatmentRADIATION

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Centre Francois Baclesse

Caen, France

Infirmerie Protestante

Caluire-et-Cuire, France

Centre Georges-François Leclerc

Dijon, France

Centre Léon Bérard

Lyon, France

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 2.5 years (after 100 patients enrolled )

Secondary Outcomes

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 )

Data from ClinicalTrials.gov

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