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Tumour and HEalthy Tissues DOse-response and Radiosensitivity Assay (THEODORA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02797405
Recruitment Status : Terminated (Withdrawal of analysis study Partner.)
First Posted : June 13, 2016
Last Update Posted : March 25, 2020
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sarcoma Rectal Carcinoma Esophagus Cancer Radiation: Standard treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : October 2016
Actual Primary Completion Date : August 13, 2019
Actual Study Completion Date : March 13, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Calibration of the correlation between the clinical tumor response and the results of A/MS bioassays using tumor samples [ Time Frame: 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.

  2. Validation of the correlation between the clinical tumor response and the results of A/MS bioassays using tumor samples [ Time Frame: 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 :
  1. 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 ) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02797405

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Centre Francois Baclesse
Caen, France
Infirmerie Protestante
Caluire-et-Cuire, France, 69641
Centre Georges-François Leclerc
Dijon, France, 21079
Centre Léon Bérard
Lyon, France, 69008
Hôpital Privé Jean Mermoz
Lyon, France, 69008
ICL - Institut de Cancérologie de la Lorraine
Vandœuvre-lès-Nancy, France, 54519
Hopital Nord Ouest Villefranche Sur Saone
Villefranche-sur-Saône, France
Sponsors and Collaborators
Centre Leon Berard
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Principal Investigator: Marie-Pierre SUNYACH, MD Centre Leon Berard
COPERNIC project investigators, Granzotto A, Benadjaoud MA, Vogin G, Devic C, Ferlazzo ML, Bodgi L, Pereira S, Sonzogni L, Forcheron F, Viau M, Etaix A, Malek K, Mengue-Bindjeme L, Escoffier C, Rouvet I, Zabot MT, Joubert A, Vincent A, Dalla Venezia N, Bourguignon M, Canat EP, d'Hombres A, Thébaud E, Orbach D, Stoppa-Lyonnet D, Radji A, Doré E, Pointreau Y, Bourgier C, Leblond P, Defachelles AS, Lervat C, Guey S, Feuvret L, Gilsoul F, Berger C, Moncharmont C, de Laroche G, Moreau-Claeys MV, Chavaudra N, Combemale P, Biston MC, Malet C, Martel-Lafay I, Laude C, Hau-Desbat NH, Ziouéche A, Tanguy R, Sunyach MP, Racadot S, Pommier P, Claude L, Baleydier F, Fleury B, de Crevoisier R, Simon JM, Verrelle P, Peiffert D, Belkacemi Y, Bourhis J, Lartigau E, Carrie C, De Vathaire F, Eschwege F, Puisieux A, Lagrange JL, Balosso J, Foray N. Influence of Nucleoshuttling of the ATM Protein in the Healthy Tissues Response to Radiation Therapy: Toward a Molecular Classification of Human Radiosensitivity. Int J Radiat Oncol Biol Phys. 2016 Mar 1;94(3):450-60. doi: 10.1016/j.ijrobp.2015.11.013. Epub 2015 Nov 14.

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Responsible Party: Centre Leon Berard Identifier: NCT02797405    
Other Study ID Numbers: ET15-003
2015-A00931-48 ( Other Identifier: ID-RCB )
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Leon Berard:
radiation therapy
in vitro diagnostic medical devices
Adverse Event post radiotherapy
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases