Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT04284969
Status:
RECRUITING
Last Update Posted:
2025-12-04
First Post:
2020-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PROADAPT-ovary/EWOC-2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 292}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-03-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-27', 'studyFirstSubmitDate': '2020-02-24', 'studyFirstSubmitQcDate': '2020-02-24', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Superiority for post-treatment complication grade≥3', 'timeFrame': 'At 30 days post-treatment', 'description': '• Superiority for post-treatment complication grade≥3 according the NCI-CTC-v4 (Common Terminology Criteria : CTC) at 30 days'}, {'measure': 'Superiority of HRQOL on the dimensions', 'timeFrame': 'At 3 months', 'description': 'Superiority of HRQOL on the dimensions: Mobility, burden of illness, emotional and physical functioning, fatigue, at 3 months'}], 'secondaryOutcomes': [{'measure': 'Post-operative morbidity according Clavien-Dindo classification at 30 and 90 days', 'timeFrame': 'At 30 and 90 days', 'description': 'Clavien Dindo classification consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The introduction of the subclasses a and b allows a contraction of the classification into 5 grades (I, II, III, IV and V) depending on the size of the population observed or the of the focus of a study.\n\nComplications that have the potential for long-lasting disability after patient\'s discharge (e.g.: paralysis of a voice cord after thyroid surgery) are highlighted in the present classification by a suffix ("d" for disability). This suffix indicates that a follow-up is required to comprehensively evaluate the outcome and related long-term quality of life.'}, {'measure': 'Therapeutic strategy (treatment plan completion rate)', 'timeFrame': '2 years', 'description': 'A complete therapeutic strategy consists of a complete cytoreductive surgery (CC0) 6 courses of chemotherapy at least in total, either in neo-adjuvant or in adjuvant setting, with at least 2 courses after surgery.'}, {'measure': 'Progression free survival', 'timeFrame': '2 years', 'description': 'Progression-free survival (PFS) is defined as the time from random assignment to disease progression or death from any cause.'}, {'measure': 'Overall survival', 'timeFrame': '2 years', 'description': 'Overall survival is defined as the time from randomization to death from any cause'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cytoreductive surgery', 'Older', 'Senior adult', 'Prehabilitation'], 'conditions': ['Ovarian Cancer', 'Surgery']}, 'descriptionModule': {'briefSummary': 'PROADAPT is a standardized geriatric intervention that is currently being co-constructed during an exploratory phase on a multi-professional and multi-disciplinary basis after a systematic analysis of published data (Figure).\n\nIt consists in: 1) before surgery: a prehabilitation of the patients including a nutritional, physical and educational preparation; 2) during the hospitalization for surgery: an optimisation of their treatments through a pharmaceutical conciliation, educational interventions, standardization of surgical procedures and enhanced rehabilitation after surgery; 3) bridging and post-discharge interventions for hospital-to-home transition.\n\nThis intervention is based on a logic change model, constructed with literature data and validated by an expert group through a DELPHI method : the rehabilitation model.\n\nThis intervention was designed to be implemented pragmatically in the centers according local habits and is currently being evaluated in several distinct hospital contexts under the name of "PROADAPT pilot study" in different tumor contexts thanks to a grant from the Regional Health Agency of Rhône-Alpes Auvergne region.\n\nPROADAPT intervention is planned to be evaluated in 4 tumor models inducing complex medico-surgical procedures considered at high risk of geriatric deconditioning. They have the same primary objectives in order to be evaluated into a meta-analysis. Results will be used to test the validity of the rehabilitation model. Therefore, it is a study reaching the goal of the population health intervention research.\n\nThe purpose of the PROADAPT-ovary/EWOC-2 study is to evaluate the impact of PROADAPT on patient\'s post-surgical outcomes in patients ≥ 70 years old with an advanced ovarian cancer (AOC).', 'detailedDescription': "With the conjunction of increased life expectancy and the increasing incidence of cancer with aging, older patient represent an increasing proportion of cancer patients. Increasing age is also associated with increased risk of co-morbidities as well as a decline of functional reserve of multiple organ systems, eventually leading in the context of the disease-and/or the treatment-related stress to functional deconditioning or organ failure.\n\nSurgery or complex medico-surgical procedures can be considered as one proof-of principle of such risks, since major cancer surgery the older population is at higher risk of morbi-mortality and unplanned hospitalization for geriatric events1.\n\nIn order to reduce complications after surgery, prehabilitation has often been considered, and 71% of the surgeons would accept a 4 weeks delay before surgery to improve patients' outcomes if shown to be beneficial2. However, the actual level of evidence depends on the interventions: high for pre-operative nutrition3, but low for physical exercise, due to heterogeneous programs with often bad adherence4. In addition, geriatric validated interventions, in order to prevent iatrogenic event, may be added in a multi-interventional model of intervention."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Woman ≥70 year old OR Woman ≥60 years with significant comorbid condition (modified Charlson index≥3) or disability (ADL score\\<6/6);\n* Histologically or cytologically proven FIGO (International Federation of Gynecology and Obstetrics) stage III to IV epithelial ovarian cancer or peritoneal primary or fallopian tube. A cytological proof is accepted if associated with a ratio of CA125/CEA \\>25 and a radiological pelvic mass.\n* Patient oriented towards a complex medical procedure defined by pelvic surgery preceded or not by antineoplastic treatment (neoadjuvant chemotherapy).\n* Therapeutic decision validated in a multidisciplinary consultation meeting\n* Life expectancy \\> 3 months.\n* Written informed consent obtained.\n* Covered by a Health System where applicable.\n\nExclusion Criteria:\n\n* Any other progressive malignant tumor interfering with the patient's prognosis.\n* Patient whose validated therapeutic management does not include cytoreductive surgery.\n* Patient unable to be regularly followed up for any reason (geographic, family, social, psychological).\n* Patient unable to understand the questionnaires.\n* Patient unable to follow and adhere to test procedures for geographic, social or psychological reasons.\n* Patient placed under guardianship or curatorship.\n* Patient deprived of liberty.\n* Concurrent participation in another interventional drug trial.\n* Patient already included in this study"}, 'identificationModule': {'nctId': 'NCT04284969', 'briefTitle': 'PROADAPT-ovary/EWOC-2', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': "Prehabilitation & Rehabilitation in Oncogeriatrics: Adaptation to Deconditioning Risk and Accompaniment of Patients' Trajectories-ovary/Elderly Women With Ovarian Cancer-2, a GINECO Multicenter Randomized Study (PROADAPT-ovary/EWOC-2)", 'orgStudyIdInfo': {'id': '69HCL18_0359'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': 'Patients treated according current practice of the inclusion center. If interventions are implemented locally (geriatric assessment, nutrition, physical activity) they may be proposed to the patient.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention arm : PROADAPT program', 'description': 'Patients benefiting from the PROADAPT (interventional arm) program.', 'interventionNames': ['Behavioral: PROADAPT program']}], 'interventions': [{'name': 'PROADAPT program', 'type': 'BEHAVIORAL', 'description': "* A pre-intervention activity by telephone follow-ups every week for 12 weeks and then every month.\n* Pre-operative physical training including strength, endurance and breathing exercises.\n* A nutrition activity.\n* An activity to educate patients (on nutrition, exercise).\n* The implementation of standardised intervention procedures, established in agreement with the surgeons' representatives.\n* A pharmaceutical drug conciliation activity: optimization of the patient's different treatments with pharmaceutical expertise.\n* A transition activity from the hospital to the home, and a telephone follow-up up to 12 weeks after the surgery.", 'armGroupLabels': ['Intervention arm : PROADAPT program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33000', 'city': 'Bordeaux', 'status': 'COMPLETED', 'country': 'France', 'facility': 'Chu Bordeaux Pellegrin', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '73000', 'city': 'Chambéry', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nathalie MARQUES', 'role': 'CONTACT', 'email': 'caroline.deyrolle@ch-chambery.fr'}], 'facility': 'CH Métropole Savoie', 'geoPoint': {'lat': 45.56628, 'lon': 5.92079}}, {'zip': '21079', 'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Leïla BENGRINE-LEFEVRE', 'role': 'CONTACT', 'email': 'lbengrine@cgfl.fr'}], 'facility': 'Centre Georges François Leclerc', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '69004', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emilie NGUYEN-BA', 'role': 'CONTACT', 'email': 'emilie.nguyen-ba@chu-lyon.fr'}], 'facility': 'Hôpital Croix Rousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Claire FALANDRY, PR', 'role': 'CONTACT', 'email': 'claire.falandry@chu-lyon.fr', 'phone': '4.78.86.32.87', 'phoneExt': '+33'}, {'name': 'Noual BAKRIN, MD', 'role': 'CONTACT', 'email': 'naoual.bakrin@chu-lyon.fr'}, {'name': 'Claire FALANDRY, PR', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Service de Gériatrie, Centre Hospitalier Lyon Sud, 165 chemin du Grand Revoyet', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '74374', 'city': 'Pringy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laetitia STEFANI', 'role': 'CONTACT', 'email': 'lstefani@ch-annecygenevois.fr'}], 'facility': 'Centre hospitalier Annecy Genevois', 'geoPoint': {'lat': 45.94622, 'lon': 6.12608}}, {'zip': '42270', 'city': 'Saint-Priest-en-Jarez', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'CHAULEUR, Céline', 'role': 'CONTACT', 'email': 'celine.chauleur@chu-st-etienne.fr'}], 'facility': 'CHU de St Etienne - Service gynécologie', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}, {'zip': '42270', 'city': 'Saint-Priest-en-Jarez', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CHU Nord Saint Etienne - Service oncologie médicale', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}, {'zip': '94805', 'city': 'Villejuif', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'FRELAUT, Maxime', 'role': 'CONTACT', 'email': 'maxime.frelaut@gustaveroussy.fr'}], 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '69616', 'city': 'Villeurbanne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marie BEGUINOT', 'role': 'CONTACT', 'email': 'm.beguinot@resamut.fr'}], 'facility': 'Médipôle Hôpital Mutualiste', 'geoPoint': {'lat': 45.76601, 'lon': 4.8795}}, {'zip': '69616', 'city': 'Villeurbanne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Sébastien KRAUTH', 'role': 'CONTACT', 'email': 'Jskrauth@hyneco-lyonvilleurbanne.fr'}], 'facility': 'Villeurbanne Médipole MHP', 'geoPoint': {'lat': 45.76601, 'lon': 4.8795}}], 'centralContacts': [{'name': 'Claire FALANDRY, PR', 'role': 'CONTACT', 'email': 'claire.falandry@chu-lyon.fr', 'phone': '4.78.86.32.87', 'phoneExt': '+33'}, {'name': 'Noual BAKRIN, MD', 'role': 'CONTACT', 'email': 'naoual.bakrin@chu-lyon.fr'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}