Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2026-01-02 @ 11:26 AM
Study NCT ID:
NCT00291850
Status:
TERMINATED
Last Update Posted:
2012-05-01
First Post:
2006-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Trial of Dose-dense Paclitaxel and Cisplatin as Neo-adjuvant Chemotherapy for Operable Stage II and IIA NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung 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': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'C455861', 'term': 'pegfilgrastim'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'whyStopped': 'no patient recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'lastUpdateSubmitDate': '2012-04-30', 'studyFirstSubmitDate': '2006-02-14', 'studyFirstSubmitQcDate': '2006-02-14', 'lastUpdatePostDateStruct': {'date': '2012-05-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the evaluation of the clinical response rate of neo-adjuvant chemotherapy with dose-dense therapy of paclitaxel and cisplatin(PC) with peg-filgrastim in patients with operable NSCLC'}], 'secondaryOutcomes': [{'measure': '>To evaluate the safety of neo-adjuvant chemotherapy with PC'}, {'measure': '- to characterize the toxicity of PC, include febrile neutropenia.'}, {'measure': '- to evaluate peri- and post-operative mortality'}, {'measure': '> to determine the pathological complete response rate'}, {'measure': '> to determine the complete tumor resection rate'}, {'measure': '> to evaluate proportion of cycle 2 and all cycles chemotherapy given with planned dose-on-time and proportion of patients receiving planned dose-on-time in cycle 2 and over all cycles.'}, {'measure': '> To evaluate the following time-to-event efficacy variables:'}, {'measure': '- disease free survival'}, {'measure': '- overall survival'}, {'measure': '> to evaluate Quality of life (EORTC QLQ-C30 and QLQ-LC13)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['NSCLC'], 'conditions': ['Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'A single arm, open-label phase II is appropriate to evaluate the efficacy and safety of dose - dense combination of paclitaxel with cisplatin supported by pegfilgrastim for neo-adjuvant chemotherapy in this patient population.', 'detailedDescription': 'This is an open-label, single-arm Phase II study of dose-dense regimen with paclitaxel and cisplatin supported by pegfilgrastim as neo-adjuvant chemotherapy in patients with operable stage II, IIA NSCLC.\n\nPaclitaxel will be administered via intravenous infusion over approximately 3 hours at dose of 175mg/m2 on Day 1 of each 14-day cycle. Cisplatin 75mg/m2 will be given via intravenous infusion on day 1 (after paclitaxel) according to institutional guidelines.\n\nPegfilgrastim (Neulasta) fixed dose of 6mg (0.6mL of a 10mg/mL solution) as a single subcutaneous injection on Day 2 of each study cycle.\n\nAll drugs will be given in 2-weekly cycle. Three cycles of pre-operative chemotherapy are planned.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* histologic or cytologic diagnosis of NSCLC\n* Presence of clinical Stage IIA,IIB or IIA disease\n* tumor amenable to curative surgical resection\n* Patients with clinically measurable lesions will be enrolled in this study.\n* No prior tumor therapy\n* Performance status of 0-1 on ECOG Scale\n* Patients compliance and geographic proximity that allow adequate follow-up.\n* Medical fitness of patient, including respiratory function, adequate for radical NSCLC surgery.\n\nExclusion Criteria:\n\n* Presence of clinical Stage IIIA disease, according to the revision by Mountain CF of American Joint Committee on Cancer.\n* Treatment within the last 30 days with any investigational drug.\n* Cocurrent administration of any other tumor therapy, including radiotherapy, cytotoxic chemotherapy, immunotherapy, molecular target therapy.\n* Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.\n* pregnancy/breast feeding\n* Serious concomitant disorders that would compromise the safety of the patient or compromise the patients ability to complete the study, at the discretion of the investigator.\n* poorly controlled diabetes mellitus\n* Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.\n* History of significant neurological or mental disorder, including seizures or dementia."}, 'identificationModule': {'nctId': 'NCT00291850', 'briefTitle': 'Phase II Trial of Dose-dense Paclitaxel and Cisplatin as Neo-adjuvant Chemotherapy for Operable Stage II and IIA NSCLC', 'organization': {'class': 'OTHER', 'fullName': 'Central European Cooperative Oncology Group'}, 'officialTitle': 'Phase II Trial of Dose-dense Paclitaxel and Cisplatin as Neo-adjuvant Chemotherapy for Operable Stage II and IIA Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'CECOG/NSCLC.3.2.002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Paclitaxel, Cisplatin, Pegfilgrastim', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'AKH, Universitätsklinik für Innere Medizin 1', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Mosdós', 'country': 'Hungary', 'facility': 'Somogy Country Pulmo and Cardio Hospital,', 'geoPoint': {'lat': 46.35379, 'lon': 17.98853}}, {'city': 'Szombathely', 'country': 'Hungary', 'facility': 'Markusovszky Hospital', 'geoPoint': {'lat': 47.23088, 'lon': 16.62155}}, {'zip': '02-781', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'M. Sklodowska-Curie Memorial Dep. Of Lung and Thoracic Tumours,', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Klinika Chirurgii Instytutu Gruzlicy i Chorob Pluc', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Maciej Krzakowski, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.Sklodowska-Curie Memorial, Dep of Lung and Thoracic Tumours, Warsaw'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central European Cooperative Oncology Group', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}