THEODORA: Tumour and HEalthy Tissues DOse-response and Radiosensitivity Assay

Sponsor

Centre Leon Berard (Other)

Overall Status

Terminated

CT.gov ID

NCT02797405

Collaborator

(none)

Enrollment

Locations

Arm

41.4

Duration (Months)

13.9

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma Rectal Carcinoma Esophagus Cancer	Radiation: Standard treatment	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

97 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Oct 1, 2016

Actual Primary Completion Date :

Aug 13, 2019

Actual Study Completion Date :

Mar 13, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Standard treatment The patients will receive standard treatment according to international recommendations depending on their type of cancer.	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

Arm

Intervention/Treatment

Other: Standard treatment

The patients will receive standard treatment according to international recommendations depending on their type of cancer.

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

Outcome Measures

Primary Outcome Measures

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

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 )]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Centre Francois Baclesse	Caen	France
2	Infirmerie Protestante	Caluire-et-Cuire	France	69641
3	Centre Georges-François Leclerc	Dijon	France	21079
4	Centre Léon Bérard	Lyon	France	69008
5	Hôpital Privé Jean Mermoz	Lyon	France	69008
6	ICL - Institut de Cancérologie de la Lorraine	Vandœuvre-lès-Nancy	France	54519
7	Hopital Nord Ouest Villefranche Sur Saone	Villefranche-sur-Saône	France