Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2026-03-01 @ 9:54 PM
Study NCT ID:
NCT01850303
Status:
COMPLETED
Last Update Posted:
2023-03-14
First Post:
2013-04-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maintenance After Induction Chemotherapy in Elderly Patients With Advanced Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D060828', 'term': 'Induction Chemotherapy'}], 'ancestors': [{'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012074', 'term': 'Remission Induction'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-11-20', 'size': 1231831, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-07-22T06:20', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 632}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-10', 'studyFirstSubmitDate': '2013-04-29', 'studyFirstSubmitQcDate': '2013-05-08', 'lastUpdatePostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Up to 15 months'}], 'secondaryOutcomes': [{'measure': 'Feasibility of treatment (number of cycles of maintenance)', 'timeFrame': '84 days on average', 'description': 'Number of cycles of maintenance (median)'}, {'measure': 'Progression free survival', 'timeFrame': 'up to 7 months'}, {'measure': 'response and stabilisation duration', 'timeFrame': 'up to 7 months'}, {'measure': 'Number of patient with at least one adverse event', 'timeFrame': 'up to 7 months'}, {'measure': 'Treatment duration', 'timeFrame': 'Up to 7 months'}, {'measure': '2nd line response rate', 'timeFrame': 'Up to 4 months'}, {'measure': 'Number of adverse events', 'timeFrame': 'Up to 7 months'}, {'measure': '2nd line overall survival', 'timeFrame': 'Up to 7 months'}, {'measure': '2nd line progression free survival', 'timeFrame': 'Up to 4 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Elderly', 'lung cancer', 'switch', 'maintenance', 'Elderly patients (between 70 and 89 years)', 'NSCLC', 'IFCT'], 'conditions': ['Non Small Cell Lung Cancer (Squamous or Non Squamous)']}, 'referencesModule': {'references': [{'pmid': '21831418', 'type': 'BACKGROUND', 'citation': 'Quoix E, Zalcman G, Oster JP, Westeel V, Pichon E, Lavole A, Dauba J, Debieuvre D, Souquet PJ, Bigay-Game L, Dansin E, Poudenx M, Molinier O, Vaylet F, Moro-Sibilot D, Herman D, Bennouna J, Tredaniel J, Ducolone A, Lebitasy MP, Baudrin L, Laporte S, Milleron B; Intergroupe Francophone de Cancerologie Thoracique. Carboplatin and weekly paclitaxel doublet chemotherapy compared with monotherapy in elderly patients with advanced non-small-cell lung cancer: IFCT-0501 randomised, phase 3 trial. Lancet. 2011 Sep 17;378(9796):1079-88. doi: 10.1016/S0140-6736(11)60780-0. Epub 2011 Aug 8.'}, {'pmid': '32898792', 'type': 'RESULT', 'citation': 'Quoix E, Audigier-Valette C, Lavole A, Molinier O, Westeel V, Barlesi F, Le Treut J, Pichon E, Dauba J, Otto J, Moreau L, Madelaine J, Dumont P, Margery J, Debieuvre D, Renault PA, Pujol JL, Langlais A, Morin F, Moro-Sibilot D, Souquet PJ. Switch maintenance chemotherapy versus observation after carboplatin and weekly paclitaxel doublet chemotherapy in elderly patients with advanced non-small cell lung cancer: IFCT-1201 MODEL trial. Eur J Cancer. 2020 Oct;138:193-201. doi: 10.1016/j.ejca.2020.07.034. Epub 2020 Sep 6.'}], 'seeAlsoLinks': [{'url': 'http://www.ifct.fr', 'label': 'IFCT official website'}]}, 'descriptionModule': {'briefSummary': 'For elderly patient, the treatment of Non Small Cell Lung Cancer was based on monotherapy but IFCT-0501 trial begun in 2006, demonstrated that a bitherapy (carboplatin and paclitaxel) is better than monotherapy in term of overall survival and progression free survival. The current recommendations are now to administer a carboplatin based bitherapy (4 or 6 cycles). After the treatment is stopped until progression and initiation of a second line treatment. The risk of this strategy is to be confronted to a rapid disease progression during the free interval. Indeed, about 1/3 of the patients whose disease was controlled after the chemotherapy do not receive 2nd line. The concept of maintenance is based on a continuous therapeutic pressure in order to preserve the therapeutic profit obtained by the treatment of 1st line (induction chemotherapy).\n\nThere is two types of maintenance :\n\n* continuous maintenance therapy which consists in continuing the treatment initially associated with platinum until disease progression.\n* switch maintenance which consists in introducing a new treatment after the end of induction chemotherapy The two types are validated by several trials. The marketing authorization of pemetrexed was enlarged to maintenance for non squamous carcinoma.\n\nGemcitabine has a good tolerance profile which make possible the use in a maintenance strategy. Several trials evaluated maintenance with this product and some show benefits in term of progression free survival.\n\nThe objective of this trial is to evaluate the switch maintenance in elderly patient with a controlled disease after 4 cycles of chemotherapy carboplatin-paclitaxel.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically documented Non Small Cell Lung Cancer non resectable or non irradiable stage III or stage IV\n* EGFR wild type or non feasible EGFR\n* 90 \\>Age ≥ 70\n* ECOG Performance status : 0, 1 or 2\n* Mini-Mental Test Status (MMS) \\> 23\n\nExclusion Criteria:\n\n* Mixed non-small cell and small cell tumors\n* Patients with EGFR mutated tumor\n* Patient with EML4-ALK translocation\n* Evolutive or symptomatic metastasis of central nervous system\n* Superior vena cava syndrome\n* Calcemia \\> 2,70 mmol/L'}, 'identificationModule': {'nctId': 'NCT01850303', 'acronym': 'MODEL', 'briefTitle': 'Maintenance After Induction Chemotherapy in Elderly Patients With Advanced Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Intergroupe Francophone de Cancerologie Thoracique'}, 'officialTitle': 'Phase III Study Comparing Maintenance With Pemetrexed or Gemcitabine to a Surveillance in Elderly Patients (70 Years Old and More) With a Advanced Non Small Cell Lung Cancer Controlled by Induction Chemotherapy.', 'orgStudyIdInfo': {'id': 'IFCT-1201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Surveillance', 'interventionNames': ['Drug: Induction chemotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Maintenance', 'description': 'Pemetrexed for non squamous NSCLC Gemcitabine for squamous NSCLC', 'interventionNames': ['Drug: Pemetrexed', 'Drug: Gemcitabine', 'Drug: Induction chemotherapy']}], 'interventions': [{'name': 'Pemetrexed', 'type': 'DRUG', 'armGroupLabels': ['Maintenance']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'armGroupLabels': ['Maintenance']}, {'name': 'Induction chemotherapy', 'type': 'DRUG', 'description': '4 cycles of carboplatin-paclitaxel', 'armGroupLabels': ['Maintenance', 'Surveillance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80142', 'city': 'Abbeville', 'country': 'France', 'facility': 'Abbeville - 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