Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2026-01-02 @ 12:39 AM
Study NCT ID:
NCT02551458
Status:
TERMINATED
Last Update Posted:
2024-03-07
First Post:
2015-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Systematic Surgery Versus Surveillance and Rescue Surgery in Operable Oesophageal Cancer With a Complete Clinical Response to Radiochemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 188}}, 'statusModule': {'whyStopped': 'sub-optimal inclusion rate, additional 9 years to finalize inclusion and follow-up of all patients.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'lastUpdateSubmitDate': '2024-03-05', 'studyFirstSubmitDate': '2015-08-20', 'studyFirstSubmitQcDate': '2015-09-14', 'lastUpdatePostDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of surviving patients', 'timeFrame': '1 year after randomisation'}, {'measure': 'Disease-free survival', 'timeFrame': 'Up to 5 years'}]}, 'conditionsModule': {'conditions': ['Epidermoid Carcinoma or', 'Adenocarcinoma of the Thoracic Oesophagus or', 'Adenocarcinoma of the Oesogastric Junction (Siewert Type I or II)', 'Stage cT2 N1-3 M0 or cT3-T4a N0 or N1-3 M0']}, 'descriptionModule': {'briefSummary': 'Step 1: Inclusion of eligible patients to carry out a translational search for prognostic and predictive markers of Complete Clinical Response and Pathologic Complete Response (using blood samples and diagnostic biopsies) and to collect data on radiochemotherapy and its toxicity.\n\nThe trial will evaluate strategies after neoadjuvant treatment and not RCT protocols. The RCT will thus be chosen by the investigator from published effective schemes in a pre-operative setting or in patients not undergoing surgery.\n\nEvaluation of the response 5 to 6 weeks after the RCT.\n\nStep 2: Randomisation in patients with a complete clinical response:\n\nArm A: Systematic surgery Arm B: Surveillance and rescue surgery in cases with resectable loco-regional recurrence\n\nPatients not eligible for randomisation will have the possibility to participate in a specific study (information can be obtained from the SAKK group (Switzerland Group Clinical Research on Cancer)).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Epidermoid carcinoma (EC) or adenocarcinoma of the thoracic oesophagus or adenocarcinoma of the oesogastric junction (Siewert type I or II) proven histologically\n* Stage cT2 N1-3 M0 or cT3-T4a N0 or N1-3 M0 after a full investigation\n* Patient considered operable with a curative intent and scheduled to undergo first-line radiochemotherapy in a multidisciplinary meeting\n* Age ≥ 18 years \\< 75 years\n* Patient with national health insurance cover and who has provided written informed consent for the clinical and biological studies.\n\nExclusion Criteria:\n\n* Cancer of the cervical oesophagus (15 to 19 cm from the dental arches)\n* Weight loss \\> 15% at the recruitment with no improvement after nutritional support\n* Serious comorbidity threatening survival in the short term\n* Contra-indication for radiochemotherapy\n* Other uncured malignant disease in the 5 previous years (except for in situ cervical carcinoma and treated non-melanotic skin cancers)\n* Absence of effective contraception in patients (men or women) able to procreate, pregnant or breast-feeding women\n* Impossibility to follow the trial\n* Legal disqualification (patients in custody or under guardianship)'}, 'identificationModule': {'nctId': 'NCT02551458', 'acronym': 'Esostrate', 'briefTitle': 'Comparison of Systematic Surgery Versus Surveillance and Rescue Surgery in Operable Oesophageal Cancer With a Complete Clinical Response to Radiochemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'SYSTEMATIC SURGERY VERSUS SURVEILLANCE AND RESCUE SURGERY IN OPERABLE CANCER OF THE OESOPHAGUS WITH A COMPLETE CLINICAL RESPONSE TO RADIOCHEMOTHERAPY', 'orgStudyIdInfo': {'id': 'Bedenne PHRC N 2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: Systematic surgery', 'interventionNames': ['Other: Systematic surgery']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B: Surveillance and rescue surgery in cases of resectable', 'interventionNames': ['Other: Surveillance and rescue surgery in cases of resectable loco-regional recurrence']}], 'interventions': [{'name': 'Systematic surgery', 'type': 'OTHER', 'armGroupLabels': ['Arm A: Systematic surgery']}, {'name': 'Surveillance and rescue surgery in cases of resectable loco-regional recurrence', 'type': 'OTHER', 'armGroupLabels': ['Arm B: Surveillance and rescue surgery in cases of resectable']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '64100', 'city': 'Bayonne', 'country': 'France', 'facility': "Centre d'oncologie et de radiothérapie du Pays Basque", 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'zip': '64109', 'city': 'Bayonne', 'country': 'France', 'facility': 'CH de la Côte Basque', 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'zip': '62200', 'city': 'Boulogne-sur-Mer', 'country': 'France', 'facility': 'Boulogne Sur Mer', 'geoPoint': {'lat': 50.72485, 'lon': 1.61373}}, {'zip': '69300', 'city': 'Caluire-et-Cuire', 'country': 'France', 'facility': 'Infirmerie protestante de Lyon', 'geoPoint': {'lat': 45.79462, 'lon': 4.8464}}, {'zip': '68024', 'city': 'Colmar', 'country': 'France', 'facility': 'Hôpitaux civils de Colmar', 'geoPoint': {'lat': 48.08078, 'lon': 7.35584}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU de DIJON', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '38700', 'city': 'La Tronche', 'country': 'France', 'facility': 'Hôpital Michallon (GRENOBLE)', 'geoPoint': {'lat': 45.20507, 'lon': 5.74629}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Claude Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '87039', 'city': 'Limoges', 'country': 'France', 'facility': 'Clinique Chenieux', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'CHU de Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '69007', 'city': 'Lyon', 'country': 'France', 'facility': 'CH Saint Joseph Saint Luc', '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': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Mutualiste MONTSOURIS', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '74374', 'city': 'Pringy', 'country': 'France', 'facility': 'Centre Hospitalier Annecy Genevois', 'geoPoint': {'lat': 45.94622, 'lon': 6.12608}}, {'zip': '35760', 'city': 'Saint-Grégoire', 'country': 'France', 'facility': 'CHP Saint Grégoire', 'geoPoint': {'lat': 48.15101, 'lon': -1.68579}}, {'zip': '94800', 'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}