NCT02797405

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Centre Leon Berard · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sarcoma
• Rectal Carcinoma
• Esophagus Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-10-01
• Primary completion: 2019-08-13
• Completion: 2020-03-13
• First posted: 2016-06-13
• Last updated: 2020-03-25

Locations

7 sites across 1 country: France