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

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ClinicalTrials.gov Identifier: NCT02797405
Recruitment Status : Recruiting
First Posted : June 13, 2016
Last Update Posted : February 6, 2019
Sponsor:
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)
Estimated Enrollment : 100 participants
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
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 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 ) ]


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


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 ClinicalTrials.gov identifier (NCT number): NCT02797405


Contacts
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Contact: Séverine METZGER 0478782786 ext +33 severine.metzger@lyon.unicancer.fr

Locations
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France
Infirmerie Protestante Recruiting
Caluire-et-Cuire, France, 69641
Contact: TAVAN David, MD    04 72 00 71 98    davidtavan@gmail.com   
Centre Georges-François Leclerc Recruiting
Dijon, France, 21079
Contact: CREHANGE Gilles, MD    03 80 73 75 17    gcrehange@cgfl.fr   
Centre Léon Bérard Recruiting
Lyon, France, 69008
Contact: Marie-Pierre SUNYACH, MD    04 78 78 26 47 ext +33    mariepierre.sunyach@lyon.unicancer.fr   
Sub-Investigator: Charles Mastier, MD         
Principal Investigator: Marie-Pierre SUNYACH, MD         
Hôpital Privé Jean Mermoz Recruiting
Lyon, France, 69008
Contact: CLAVEL Léa, MD    04 37 53 87 26    leaclavel1@gmail.com   
ICL - Institut de Cancérologie de la Lorraine Recruiting
Vandœuvre-lès-Nancy, France, 54519
Contact: VOGIN Guillaume, MD    03 83 59 84 27    g.vogin@nancy.unicancer.fr   
Sponsors and Collaborators
Centre Leon Berard
Investigators
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Principal Investigator: Marie-Pierre SUNYACH, MD Centre Leon Berard

Publications:
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
ClinicalTrials.gov Identifier: NCT02797405     History of Changes
Other Study ID Numbers: ET15-003
2015-A00931-48 ( Other Identifier: ID-RCB )
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centre Leon Berard:
radiation therapy
radiosensitivity
in vitro diagnostic medical devices
Adverse Event post radiotherapy

Additional relevant MeSH terms:
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Esophageal Neoplasms
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases