Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-02-17 @ 11:07 PM
Study NCT ID:
NCT02797405
Status:
TERMINATED
Last Update Posted:
2020-03-25
First Post:
2016-06-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tumour and HEalthy Tissues DOse-response and Radiosensitivity Assay
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'whyStopped': 'Withdrawal of analysis study Partner.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-23', 'studyFirstSubmitDate': '2016-06-08', 'studyFirstSubmitQcDate': '2016-06-08', 'lastUpdatePostDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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 )', 'description': '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.'}, {'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 )', 'description': '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.'}], 'secondaryOutcomes': [{'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 )'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['radiation therapy', 'radiosensitivity', 'in vitro diagnostic medical devices', 'Adverse Event post radiotherapy'], 'conditions': ['Sarcoma', 'Rectal Carcinoma', 'Esophagus Cancer']}, 'referencesModule': {'references': [{'pmid': '16080176', 'type': 'BACKGROUND', 'citation': 'Delaney G, Jacob S, Featherstone C, Barton M. The role of radiotherapy in cancer treatment: estimating optimal utilization from a review of evidence-based clinical guidelines. Cancer. 2005 Sep 15;104(6):1129-37. doi: 10.1002/cncr.21324.'}, {'pmid': '16086915', 'type': 'BACKGROUND', 'citation': 'Bentzen SM, Heeren G, Cottier B, Slotman B, Glimelius B, Lievens Y, van den Bogaert W. Towards evidence-based guidelines for radiotherapy infrastructure and staffing needs in Europe: the ESTRO QUARTS project. Radiother Oncol. 2005 Jun;75(3):355-65. doi: 10.1016/j.radonc.2004.12.007. Epub 2005 Mar 16.'}, {'pmid': '22325993', 'type': 'BACKGROUND', 'citation': 'Lievens Y, Grau C. Health economics in radiation oncology: introducing the ESTRO HERO project. Radiother Oncol. 2012 Apr;103(1):109-12. doi: 10.1016/j.radonc.2011.12.026. Epub 2012 Feb 8.'}, {'pmid': '11730991', 'type': 'BACKGROUND', 'citation': 'Dorr W, Hendry JH. Consequential late effects in normal tissues. Radiother Oncol. 2001 Dec;61(3):223-31. doi: 10.1016/s0167-8140(01)00429-7.'}, {'pmid': '23735818', 'type': 'BACKGROUND', 'citation': 'Bodgi L, Granzotto A, Devic C, Vogin G, Lesne A, Bottollier-Depois JF, Victor JM, Maalouf M, Fares G, Foray N. A single formula to describe radiation-induced protein relocalization: towards a mathematical definition of individual radiosensitivity. J Theor Biol. 2013 Sep 21;333:135-45. doi: 10.1016/j.jtbi.2013.05.020. Epub 2013 Jun 2.'}, {'pmid': '22919036', 'type': 'BACKGROUND', 'citation': 'Foray N, Colin C, Bourguignon M. 100 years of individual radiosensitivity: how we have forgotten the evidence. Radiology. 2012 Sep;264(3):627-31. doi: 10.1148/radiol.12112560. No abstract available.'}, {'pmid': '18246480', 'type': 'BACKGROUND', 'citation': 'Joubert A, Zimmerman KM, Bencokova Z, Gastaldo J, Chavaudra N, Favaudon V, Arlett CF, Foray N. DNA double-strand break repair defects in syndromes associated with acute radiation response: at least two different assays to predict intrinsic radiosensitivity? Int J Radiat Biol. 2008 Feb;84(2):107-25. doi: 10.1080/09553000701797039.'}, {'pmid': '21333944', 'type': 'BACKGROUND', 'citation': 'Granzotto A, Joubert A, Viau M, Devic C, Maalouf M, Thomas C, Vogin G, Malek K, Colin C, Balosso J, Foray N. [Individual response to ionising radiation: What predictive assay(s) to choose?]. C R Biol. 2011 Feb;334(2):140-57. doi: 10.1016/j.crvi.2010.12.018. French.'}, {'pmid': '12679524', 'type': 'BACKGROUND', 'citation': 'Rothkamm K, Lobrich M. Evidence for a lack of DNA double-strand break repair in human cells exposed to very low x-ray doses. Proc Natl Acad Sci U S A. 2003 Apr 29;100(9):5057-62. doi: 10.1073/pnas.0830918100. Epub 2003 Apr 4.'}, {'pmid': '26867874', 'type': 'BACKGROUND', 'citation': "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, Thebaud E, Orbach D, Stoppa-Lyonnet D, Radji A, Dore 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, Zioueche 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. 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Phase II trial of preoperative chemoradiation with a hyperfractionated radiation boost in locally advanced rectal cancer. Am J Clin Oncol. 2006 Oct;29(5):435-41. doi: 10.1097/01.coc.0000227480.41414.f2.'}, {'pmid': '9747819', 'type': 'BACKGROUND', 'citation': 'Wagman R, Minsky BD, Cohen AM, Guillem JG, Paty PP. Sphincter preservation in rectal cancer with preoperative radiation therapy and coloanal anastomosis: long term follow-up. Int J Radiat Oncol Biol Phys. 1998 Aug 1;42(1):51-7. doi: 10.1016/s0360-3016(98)00180-1.'}, {'pmid': '8622034', 'type': 'BACKGROUND', 'citation': 'Pisters PW, Harrison LB, Leung DH, Woodruff JM, Casper ES, Brennan MF. Long-term results of a prospective randomized trial of adjuvant brachytherapy in soft tissue sarcoma. 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Int J Hyperthermia. 2009 Jun;25(4):289-98. doi: 10.1080/02656730902873616.'}, {'pmid': '12103287', 'type': 'BACKGROUND', 'citation': "O'Sullivan B, Davis AM, Turcotte R, Bell R, Catton C, Chabot P, Wunder J, Kandel R, Goddard K, Sadura A, Pater J, Zee B. Preoperative versus postoperative radiotherapy in soft-tissue sarcoma of the limbs: a randomised trial. Lancet. 2002 Jun 29;359(9325):2235-41. doi: 10.1016/S0140-6736(02)09292-9."}, {'pmid': '10235156', 'type': 'BACKGROUND', 'citation': 'Cooper JS, Guo MD, Herskovic A, Macdonald JS, Martenson JA Jr, Al-Sarraf M, Byhardt R, Russell AH, Beitler JJ, Spencer S, Asbell SO, Graham MV, Leichman LL. Chemoradiotherapy of locally advanced esophageal cancer: long-term follow-up of a prospective randomized trial (RTOG 85-01). Radiation Therapy Oncology Group. JAMA. 1999 May 5;281(17):1623-7. doi: 10.1001/jama.281.17.1623.'}, {'pmid': '12860946', 'type': 'BACKGROUND', 'citation': 'Ishikura S, Nihei K, Ohtsu A, Boku N, Hironaka S, Mera K, Muto M, Ogino T, Yoshida S. Long-term toxicity after definitive chemoradiotherapy for squamous cell carcinoma of the thoracic esophagus. J Clin Oncol. 2003 Jul 15;21(14):2697-702. doi: 10.1200/JCO.2003.03.055.'}, {'pmid': '19327900', 'type': 'BACKGROUND', 'citation': 'Morota M, Gomi K, Kozuka T, Chin K, Matsuura M, Oguchi M, Ito H, Yamashita T. Late toxicity after definitive concurrent chemoradiotherapy for thoracic esophageal carcinoma. Int J Radiat Oncol Biol Phys. 2009 Sep 1;75(1):122-8. doi: 10.1016/j.ijrobp.2008.10.075. Epub 2009 Mar 26.'}, {'pmid': '19403881', 'type': 'BACKGROUND', 'citation': 'Wahl RL, Jacene H, Kasamon Y, Lodge MA. From RECIST to PERCIST: Evolving Considerations for PET response criteria in solid tumors. J Nucl Med. 2009 May;50 Suppl 1(Suppl 1):122S-50S. doi: 10.2967/jnumed.108.057307.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'For that purpose, this project is composed of 3 stages:\n\n* 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\n* 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).\n* 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).\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nI1. 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.\n\nExclusion Criteria:\n\nE1. Contra-indication to radiotherapy E2. Contra-indication to skin biopsy'}, 'identificationModule': {'nctId': 'NCT02797405', 'acronym': 'THEODORA', 'briefTitle': 'Tumour and HEalthy Tissues DOse-response and Radiosensitivity Assay', 'organization': {'class': 'OTHER', 'fullName': 'Centre Leon Berard'}, 'officialTitle': 'Evaluation of Individual Radiosensitivity of Cancer Patients to be Treated by Radiotherapy or Radiochemotherapy Per-operative', 'orgStudyIdInfo': {'id': 'ET15-003'}, 'secondaryIdInfos': [{'id': '2015-A00931-48', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Standard treatment', 'description': 'The patients will receive standard treatment according to international recommendations depending on their type of cancer.', 'interventionNames': ['Radiation: Standard treatment']}], 'interventions': [{'name': 'Standard treatment', 'type': 'RADIATION', 'description': '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', 'armGroupLabels': ['Standard treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Caen', 'country': 'France', 'facility': 'Centre Francois Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '69641', 'city': 'Caluire-et-Cuire', 'country': 'France', 'facility': 'Infirmerie Protestante', 'geoPoint': {'lat': 45.79462, 'lon': 4.8464}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'Centre Georges-François Leclerc', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '69008', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Léon Bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69008', 'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital Privé Jean Mermoz', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '54519', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'ICL - Institut de Cancérologie de la Lorraine', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'city': 'Villefranche-sur-Saône', 'country': 'France', 'facility': 'Hopital Nord Ouest Villefranche Sur Saone', 'geoPoint': {'lat': 45.98967, 'lon': 4.71961}}], 'overallOfficials': [{'name': 'Marie-Pierre SUNYACH, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Leon Berard'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Leon Berard', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}