Clinical trial NCT02797405: Tumour and HEalthy Tissues DOse-response and Radiosensitivity Assay
Official title: Evaluation of Individual Radiosensitivity of Cancer Patients to be Treated by Radiotherapy or Radiochemotherapy Per-operative
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sarcoma
Rectal Carcinoma
Esophagus Cancer
Keywords: radiation therapy
radiosensitivity
in vitro diagnostic medical devices
Adverse Event post radiotherapy
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2016-06-13
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Calibration of the correlation between the clinical tumor response and the results of A/MS bioassays using tumor samples
timeFrame: 2.5 years (after 100 patients enrolled )
measure: Validation of the correlation between the clinical tumor response and the results of A/MS bioassays using tumor samples
timeFrame: 2.5 years (after 100 patients enrolled )
Secondary outcomes:
measure: 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
timeFrame: 2.5 years (after 100 patients enrolled )
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre Francois Baclesse
city: Caluire-et-Cuire
country: France
facility: Infirmerie Protestante
city: Dijon
country: France
facility: Centre Georges-François Leclerc
city: Lyon
country: France
facility: Centre Léon Bérard
city: Lyon
country: France
facility: Hôpital Privé Jean Mermoz
city: Vandœuvre-lès-Nancy
country: France
facility: ICL - Institut de Cancérologie de la Lorraine
city: Villefranche-sur-Saône
country: France
facility: Hopital Nord Ouest Villefranche Sur Saone
Study officials:
affiliation: Centre Leon Berard
name: Marie-Pierre SUNYACH, MD
role: PRINCIPAL_INVESTIGATOR
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