Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-01-06 @ 6:43 PM
Study NCT ID:
NCT00863460
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2019-02-05
First Post:
2009-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cranial Radiotherapy or Intensive Chemotherapy With Hematopoietic Stem Cell Rescue for Primary Central Nervous System Lymphoma in Young Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-04', 'studyFirstSubmitDate': '2009-03-16', 'studyFirstSubmitQcDate': '2009-03-17', 'lastUpdatePostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2-years progression-free survival in each arm', 'timeFrame': '2 years after inclusion'}], 'secondaryOutcomes': [{'measure': 'Overall response rate at the end of the procedure', 'timeFrame': 'at the end of procedure at 1 and 2 years'}, {'measure': 'Overall survival', 'timeFrame': '2 years after inclusion'}, {'measure': 'Event-free survival', 'timeFrame': '2 years after inclusion'}, {'measure': 'Neurotoxicity', 'timeFrame': 'each years during ten years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Central Nervous System Lymphoma']}, 'referencesModule': {'references': [{'pmid': '35834762', 'type': 'DERIVED', 'citation': 'Houillier C, Dureau S, Taillandier L, Houot R, Chinot O, Molucon-Chabrot C, Schmitt A, Gressin R, Choquet S, Damaj G, Peyrade F, Abraham J, Delwail V, Gyan E, Sanhes L, Cornillon J, Garidi R, Delmer A, Al Jijakli A, Morel P, Waultier A, Paillassa J, Chauchet A, Gastinne T, Laadhari M, Plissonnier AS, Feuvret L, Cassoux N, Touitou V, Ricard D, Hoang-Xuan K, Soussain C; LOC Network for CNS Lymphoma. Radiotherapy or Autologous Stem-Cell Transplantation for Primary CNS Lymphoma in Patients Age 60 Years and Younger: Long-Term Results of the Randomized Phase II PRECIS Study. J Clin Oncol. 2022 Nov 10;40(32):3692-3698. doi: 10.1200/JCO.22.00491. Epub 2022 Jul 14.'}, {'pmid': '30785830', 'type': 'DERIVED', 'citation': 'Houillier C, Taillandier L, Dureau S, Lamy T, Laadhari M, Chinot O, Molucon-Chabrot C, Soubeyran P, Gressin R, Choquet S, Damaj G, Thyss A, Abraham J, Delwail V, Gyan E, Sanhes L, Cornillon J, Garidi R, Delmer A, Tanguy ML, Al Jijakli A, Morel P, Bourquard P, Moles MP, Chauchet A, Gastinne T, Constans JM, Langer A, Martin A, Moisson P, Lacomblez L, Martin-Duverneuil N, Delgadillo D, Turbiez I, Feuvret L, Cassoux N, Touitou V, Ricard D, Hoang-Xuan K, Soussain C; Intergroupe GOELAMS-ANOCEF and the LOC Network for CNS Lymphoma. Radiotherapy or Autologous Stem-Cell Transplantation for Primary CNS Lymphoma in Patients 60 Years of Age and Younger: Results of the Intergroup ANOCEF-GOELAMS Randomized Phase II PRECIS Study. J Clin Oncol. 2019 Apr 1;37(10):823-833. doi: 10.1200/JCO.18.00306. Epub 2019 Feb 20.'}]}, 'descriptionModule': {'briefSummary': 'Purpose of the study :\n\nTo evaluate the antitumoral effect of two therapeutic procedures and to evaluate their respective toxicity on the CNS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histopathologically or cytologically proven diagnostic of Primary CNS lymphoma\n* All histological types of non-Hodgkin's lymphoma, except MALT\n* Age \\> 18 and \\< 60 ans.\n* Negative for HIV, HCV and HBV\n* Written informed consent -\n\nExclusion Criteria:\n\n* Age \\< 18 or \\> 60 ans\n* Isolated intra-ocular lymphoma\n* Previous history of indolent lymphoma\n* Previous chemotherapy or radiotherapy for PCNSL\n* Isolated CNS relapse of systemic NHL\n* Previous history of cancer in the last 5 years, except basocellular carcinoma and non invasive cervix cancer\n* Renal insufficiency or creatinin clearance \\< 60 ml/min\n* Liver enzymes \\> 3N.\n* Platelets \\< 100 000/mm3 or neutrophils \\< 1500/mm3)\n* Previous history of organ transplantation or other cause of severe immunodeficiency\n* Pregnancy or active sexual women with no contraception\n* Unable to follow the protocol for any reason"}, 'identificationModule': {'nctId': 'NCT00863460', 'acronym': 'PRECIS', 'briefTitle': 'Cranial Radiotherapy or Intensive Chemotherapy With Hematopoietic Stem Cell Rescue for Primary Central Nervous System Lymphoma in Young Patients', 'organization': {'class': 'OTHER', 'fullName': 'Institut Curie'}, 'officialTitle': 'Prospective , Multicentric, Randomized Phase II Study, Evaluating the Role of Cranial Radiotherapy or Intensive Chemotherapy With Hematopoietic Stem Cell Rescue After Conventional Chemotherapy for Primary Central Nervous System in Young Patients (< 60 y)', 'orgStudyIdInfo': {'id': 'CRH 07/422/H'}, 'secondaryIdInfos': [{'id': 'EudraCT N° 2007-005378-30'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'MTX-based chemotherapy followed by WBRT', 'interventionNames': ['Radiation: cranial radiotherapy', 'Drug: MTX based chemotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'MTX-based chemotherapy followed by intensive chemotherapy and hematopoietic stem cell rescue', 'interventionNames': ['Drug: intensive chemotherapy and hematopoietic stem cell rescue', 'Drug: MTX based chemotherapy']}], 'interventions': [{'name': 'cranial radiotherapy', 'type': 'RADIATION', 'description': '40 Gy', 'armGroupLabels': ['A']}, {'name': 'intensive chemotherapy and hematopoietic stem cell rescue', 'type': 'DRUG', 'otherNames': ['Thiotepa IV (250 mg/m²/day) day-9 day-8 day-7', 'Busulfan IV (0.8 mg/kg X 10) day-6 to day-4', 'Cyclophosphamide IV (60 mg/kg/day) day-3 & day-2', 'Reinjection of hematopoietic stem cells day0'], 'description': 'intensive chemotherapy and hematopoietic stem cell rescue', 'armGroupLabels': ['B']}, {'name': 'MTX based chemotherapy', 'type': 'DRUG', 'otherNames': ['R-RMVP :', 'Rituximab IV if LNH type B (375 mg/m²) day1', 'Methotrexate IV (3g/m² during 30 minutes) day1 and day15', 'Etoposide IV (100 mg/m²) day2', 'Carmustine IV (100 mg/m²) day3', 'Prednisone PO (60 mg/m²/day)day1 to day5', 'R-Aracytine :', 'Aracytine IV (3g/m²) day1 & day2'], 'description': 'R-MBVP 2 cycles day1 and day28 followed by R-Aracytine 2 cycles days58\\&59 and days79\\&80', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'Cancérologie Hôpital Sud', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Angers', 'country': 'France', 'facility': "Chu D'Angers", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '95100', 'city': 'Argenteuil', 'country': 'France', 'facility': 'CHR Argenteuil', 'geoPoint': {'lat': 48.94788, 'lon': 2.24744}}, {'city': 'Besançon', 'country': 'France', 'facility': 'CHU de Besancon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonié', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Hôtel Dieu', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU Michalon', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Lens', 'country': 'France', 'facility': 'Centre Hospitalier Lens', 'geoPoint': {'lat': 50.43302, 'lon': 2.82791}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'CHU de Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '13009', 'city': 'Marseille', 'country': 'France', 'facility': 'CHU de la Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Nantes', 'country': 'France', 'facility': 'Hôtel Dieu Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nice', 'country': 'France', 'facility': 'Centre Antoine Lacassagne', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Nîmes', 'country': 'France', 'facility': 'CHU de Nimes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'GH Pitié-Salpétrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '66046', 'city': 'Perpignan', 'country': 'France', 'facility': 'CHG Saint Jean', 'geoPoint': {'lat': 42.69764, 'lon': 2.89541}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU Hôpital Bernard', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Reims', 'country': 'France', 'facility': 'Chu Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'Hôpital Pontchaillou', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '92210', 'city': 'Saint-Cloud', 'country': 'France', 'facility': 'Centre René Huguenin', 'geoPoint': {'lat': 48.84598, 'lon': 2.20289}}, {'city': 'Saint-Priest-en-Jarez', 'country': 'France', 'facility': 'Institut de Cancérologie', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}, {'city': 'Saint-Quentin', 'country': 'France', 'facility': 'CH de Saint-Quentin', 'geoPoint': {'lat': 49.84889, 'lon': 3.28757}}, {'city': 'Tours', 'country': 'France', 'facility': 'Hôpital Bretonneau', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'CHU Nancy - Hôpital Neurologique', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'overallOfficials': [{'name': 'Carole Soussain, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Curie - Hôpital René Huguenin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Curie', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}, {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, {'name': 'Amgen', 'class': 'INDUSTRY'}, {'name': 'Pierre Fabre Laboratories', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}