Tumour and HEalthy Tissues DOse-response and Radiosensitivity Assay
- Conditions
- SarcomaRectal CarcinomaEsophagus Cancer
- Interventions
- Radiation: Standard treatment
- Registration Number
- NCT02797405
- Lead Sponsor
- Centre Leon Berard
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 97
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.
E1. Contra-indication to radiotherapy E2. Contra-indication to skin biopsy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Standard treatment Standard treatment The patients will receive standard treatment according to international recommendations depending on their type of cancer.
- Primary Outcome Measures
Name Time Method Calibration of the correlation between the clinical tumor response and the results of A/MS bioassays using tumor samples 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 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.
- Secondary Outcome Measures
Name Time Method 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 )
Trial Locations
- Locations (7)
Centre Georges-François Leclerc
🇫🇷Dijon, France
Centre Léon Bérard
🇫🇷Lyon, France
Infirmerie Protestante
🇫🇷Caluire-et-Cuire, France
Centre Francois Baclesse
🇫🇷Caen, France
Hôpital Privé Jean Mermoz
🇫🇷Lyon, France
ICL - Institut de Cancérologie de la Lorraine
🇫🇷Vandœuvre-lès-Nancy, France
Hopital Nord Ouest Villefranche Sur Saone
🇫🇷Villefranche-sur-Saône, France