Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-29 @ 1:32 PM
Study NCT ID:
NCT06211257
Status:
RECRUITING
Last Update Posted:
2024-11-20
First Post:
2024-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Superiority Trial Evaluating Digitalized Information Media for Patients with Advanced Sarcomas Receiving Second Line Treatment.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D019150', 'term': 'Neuroaxonal Dystrophies'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized 1:1'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 377}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-18', 'studyFirstSubmitDate': '2024-01-08', 'studyFirstSubmitQcDate': '2024-01-08', 'lastUpdatePostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severe toxicity in the first 3 months of treatment', 'timeFrame': '3 months', 'description': 'Severe toxicity will be assessed through the reporting of adverse events (AE). Will be considered as an AE all indesirable medical event regardless of the cause, occurring between randomisation and the end of treatment + 30days or the start of a new systemic anti-cancer treatment or the 24-month follow-up.\n\nAll AE grade ≥ 3 according to Common Terminology Criteria for Adverse Events v5.0 scale (NCI-CTCAE) will be considered severe.'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival (PFS)', 'timeFrame': '24 months', 'description': 'PFS will be defined as the time from randomisation to investigator-assessed disease progression (RECIST 1.1 or clinical). No progressive-patients will be censured at the 24-months follow-up.'}, {'measure': 'Overall survival (OS)', 'timeFrame': '24 months', 'description': "OS will be defined as the time from randomisation to patient's death regardless of the cause. Alive patients will be censured at the 24-month follow-up."}, {'measure': 'Severe toxicity', 'timeFrame': '24 months', 'description': 'Severe toxicity will be assessed through the reporting of adverse events (AE). Will be considered as an AE all indesirable medical event regardless of the relationship, occurring between randomization and the end of treatment + 30days or the stard of a new systemic anticancer treatment or the 24-month follow-up.\n\nAll AE grade ≥ 3 according to Common Terminology Criteria for Adverse Events v5.0 scale (NCI-CTCAE) will be considered severe.'}, {'measure': 'Nature of severe AEs', 'timeFrame': '24 months', 'description': 'Description of the nature of severe adverse events occuring between randomization and the end of treatment + 30days or the start of a new systemic anticancer treatment or the 24-month follow-up, especially:\n\n* Asthenia ;\n* Gastrointestinal disorders: vomiting, anorexia, mucositis/aphthosis, diarrhea, constipation;\n* Skin disorders: hand-foot syndrome, phototoxicity, dry skin skin dryness;\n* Hypertension;\n* Hematological toxicity ;\n* Hematuric cystitis with ifosfamide;\n* Ifosfamide encephalopathy;\n* Extravasation with trabectedine;'}, {'measure': 'AEs leading to hospitalization', 'timeFrame': '24 months', 'description': 'Description of the adverse events leading to hospitalisation occuring between randomization and the end of treatment + 30days or the start of a new systemic anticancer treatment or the 24-month follow-up.'}, {'measure': 'Survival weighted by quality of life', 'timeFrame': '24 months', 'description': 'Survival weighted by quality of life with the "Quality adjusted Time Without Symptoms and Toxicit" method (Q-Twist)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sarcoma', 'Advanced', 'Dematerialised', 'Care', 'Plan'], 'conditions': ['Sarcoma Metastatic', 'Locally Advanced Soft Tissue Sarcoma']}, 'descriptionModule': {'briefSummary': 'ePPS-2202 is a study designed to evaluate the benefits of a dematerialised personalised care plan (PCP) compared to standard information/PCP for patients with advanced sarcomas receiving second-line treatment.\n\nParticipants will be randomised to an experimental group or a control group. Patients in the experimental group will receive the dematerialised PCP in addition to the standard PCP while patients in the control group will receive the standard PCP alone.\n\nAll patients will be followed until the end of second-line treatment, the start of a new line of treatment, or until the 24-month follow-up.', 'detailedDescription': 'ePPS-2202 is a phase 3, randomised,open-label, controlled, multicentre interventional study, designed to evaluate the benefits of a dematerialised personalised care plan (PCP) compared to standard information/PCP in patients with metastatic of locally advanced sarcomas with indication of a second-line treatment with pazopanib, tracbectedine, eribuline, ifosfamide or dacarbazine after failure of a first-line anthracycline-based regimen.\n\nParticipants will be randomised to the experimental arm or the control arm. Patients in the experimental arm will receive the dematerialised PCP in addition to the standard PCP while patients in the control arm will receive the standard PCP alone.\n\nAll patients will be followed until the end of second-line treatment, the start of a new line of treatment, or until the 24-month follow-up.\n\nThe main analysis will compare the proportion of patients in each arm who experience at least one severe adverse event during the first 3 months of second-line treatment. Adverse events will be considered severe if they are graded 3 or higher according to NCI-CTCAE v5.0.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sarcomas of soft tissues or viscera ;\n* Inoperable metastatic or locally advanced disease ;\n* Indication for 2nd-line treatment with pazopanib, trabectedine, eribulin, ifosfamide or dacarbazine after failure of 1st-line anthracycline therapy ;\n* Patient covered by French social security ;\n* Written, signed, informed consent ;\n\nExclusion Criteria:\n\n* Poor understanding of French ;\n* Difficulty accessing a computer ;\n* Pregnant or nursing woman ;\n* Person deprived of liberty or under guardianship ;\n* Impossibility of undergoing medical follow-up for geographical, social or psychological reasons.'}, 'identificationModule': {'nctId': 'NCT06211257', 'acronym': 'ePPS-2202', 'briefTitle': 'Superiority Trial Evaluating Digitalized Information Media for Patients with Advanced Sarcomas Receiving Second Line Treatment.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Oscar Lambret'}, 'officialTitle': 'Phase 3 Superiority Trial Evaluating the Benefit of Dematerialized Information Media for Patients with Advanced Sarcomas Receiving Second Line Treatment.', 'orgStudyIdInfo': {'id': 'ePPS-2202'}, 'secondaryIdInfos': [{'id': '2023-A00984-41', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group : standard PCP', 'description': 'Patient will receive standard support PCP'}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group : demateralized PCP', 'description': 'Patient will receive standard support PCP and dematerialized PCP (ePCP)', 'interventionNames': ['Other: Dematerialized Personalized Care Plan (ePCP)']}], 'interventions': [{'name': 'Dematerialized Personalized Care Plan (ePCP)', 'type': 'OTHER', 'description': 'Post-treatment support with standard support combined with dematerialized support', 'armGroupLabels': ['Experimental group : demateralized PCP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69373', 'city': 'Lyon', 'state': 'Auvergne-Rhône-Alpes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Armelle DUFRESNE, MD', 'role': 'CONTACT', 'email': 'armelle.dufresne@lyon-unicancer.fr', 'phone': '+33 (0) 4 69 85 61 47'}, {'name': 'Armelle DUFRESNE, MD', 'role': 'CONTACT'}], 'facility': 'Centre Léon Bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '25000', 'city': 'Besançon', 'state': 'Bourgogne-Franche-Comté', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Loic CHAIGNEAU, MD', 'role': 'CONTACT', 'email': 'lchaigneau@chu-besancon.fr', 'phone': '+33 (0) 3 70 63 20 05'}, {'name': 'Loic CHAIGNEAU, MD', 'role': 'CONTACT'}], 'facility': 'CHU Jean Minjoz', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '35042', 'city': 'Rennes', 'state': 'Brittany Region', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Perrine VUAGNAT, MD', 'role': 'CONTACT', 'email': 'p.vuagnat@rennes.unicancer.fr', 'phone': '+33 (0) 2 99 25 29 69'}, {'name': 'Perrine VUAGNAT, MD', 'role': 'CONTACT'}], 'facility': 'Centre Eugène Marquis', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '67033', 'city': 'Strasbourg', 'state': 'Grand Est', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sophie MARTIN, MD', 'role': 'CONTACT', 'email': 's.martin@icans.eu', 'phone': '+33 (0) 3 68 76 72 07'}, {'name': 'Sophie MARTIN, MD', 'role': 'CONTACT'}], 'facility': 'Institut de Cancérologie Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '59020', 'city': 'Lille', 'state': 'Hauts-de-France', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Diane PANNIER, MD', 'role': 'CONTACT', 'email': 'd-pannier@o-lambret.fr', 'phone': '+33 (0) 3 20 29 59 59'}, {'name': 'Diane PANNIER, MD', 'role': 'CONTACT'}], 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '86021', 'city': 'Poitiers', 'state': 'Nouvelle-Aquitaine', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marjorie HIRSCH, MD', 'role': 'CONTACT', 'email': 'marjorie.hirsch@chu-poitiers.fr', 'phone': '+33 (0) 5 49 44 07 11'}, {'name': 'Marjorie HIRSCH, MD', 'role': 'CONTACT'}], 'facility': 'CHU de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '31059', 'city': 'Toulouse', 'state': 'Occitanie', 'status': 'WITHDRAWN', 'country': 'France', 'facility': 'Institut Claudius Regaud', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '44805', 'city': 'Saint-Herblain', 'state': 'Pays de la Loire Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emmanuelle BOMPAS, MD', 'role': 'CONTACT', 'email': 'emmanuelle.bompas@ico.unicancer.fr', 'phone': '+33 (0) 2 40 67 99 00'}, {'name': 'Emmanuelle BOMPAS, MD', 'role': 'CONTACT'}], 'facility': "Institut de Cancérologie de l'Ouest", 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'zip': '75013', 'city': 'Paris', 'state': 'Île-de-France Region', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Aurore VOZY, MD', 'role': 'CONTACT', 'email': 'aurore.vozy@aphp.fr', 'phone': '+33 (0) 1 42 16 05 08'}, {'name': 'Aurore VOZY, MD', 'role': 'CONTACT'}], 'facility': 'Hôpital Pitié-Salpêtrière AP-HP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '94800', 'city': 'Villejuif', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Benjamin VERRET, MD', 'role': 'CONTACT', 'email': 'benjamin.verret@gustaveroussy.fr', 'phone': '+33 (0) 1 42 11 42 11'}, {'name': 'Benjamin VERRET, MD', 'role': 'CONTACT'}], 'facility': 'Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'centralContacts': [{'name': 'PANNIER Diane, DR', 'role': 'CONTACT', 'email': 'd-pannier@o-lambret.fr', 'phone': '03.20.29.59.59'}, {'name': 'THERY Julien, MD', 'role': 'CONTACT', 'email': 'J-THERY@o-lambret.fr'}], 'overallOfficials': [{'name': 'Diane PANNIER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Oscar Lambret'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Oscar Lambret', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canceropôle Nord Ouest', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}