Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-02-25 @ 4:59 PM
Study NCT ID:
NCT02498860
Status:
COMPLETED
Last Update Posted:
2021-08-06
First Post:
2015-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Adjuvant Pemetrexed Plus Cisplatin for Adenocarcinoma of Lung
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'D002945', 'term': 'Cisplatin'}], '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': '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-01', 'studyFirstSubmitDate': '2015-07-13', 'studyFirstSubmitQcDate': '2015-07-14', 'lastUpdatePostDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease free survival rate', 'timeFrame': '2 year', 'description': 'Disease free survival time is measured from the date of enrollment to date of tumor recurrence.'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '4 year', 'description': 'Overall survival time is measured from the date of enrollment to date of death from any cause. Participants who are alive when the data lock or is lost to follow-up will have their overall survival time censored on the last date the participant is known to be alive.'}, {'measure': 'Adverse events', 'timeFrame': '4 months', 'description': 'adverse events using common terminology criteria for adverse events 4.0'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['adenocarcinoma', 'lung', 'adjuvant chemotherapy', 'pemetrexed', 'cisplatin', 'surgery'], 'conditions': ['Adenocarcinoma', 'Lung Neoplasm']}, 'referencesModule': {'references': [{'pmid': '23161898', 'type': 'RESULT', 'citation': 'Kreuter M, Vansteenkiste J, Fischer JR, Eberhardt W, Zabeck H, Kollmeier J, Serke M, Frickhofen N, Reck M, Engel-Riedel W, Neumann S, Thomeer M, Schumann C, De Leyn P, Graeter T, Stamatis G, Zuna I, Griesinger F, Thomas M; TREAT investigators. Randomized phase 2 trial on refinement of early-stage NSCLC adjuvant chemotherapy with cisplatin and pemetrexed versus cisplatin and vinorelbine: the TREAT study. Ann Oncol. 2013 Apr;24(4):986-92. doi: 10.1093/annonc/mds578. Epub 2012 Nov 15.'}, {'pmid': '16945766', 'type': 'RESULT', 'citation': 'Douillard JY, Rosell R, De Lena M, Carpagnano F, Ramlau R, Gonzales-Larriba JL, Grodzki T, Pereira JR, Le Groumellec A, Lorusso V, Clary C, Torres AJ, Dahabreh J, Souquet PJ, Astudillo J, Fournel P, Artal-Cortes A, Jassem J, Koubkova L, His P, Riggi M, Hurteloup P. Adjuvant vinorelbine plus cisplatin versus observation in patients with completely resected stage IB-IIIA non-small-cell lung cancer (Adjuvant Navelbine International Trialist Association [ANITA]): a randomised controlled trial. Lancet Oncol. 2006 Sep;7(9):719-27. doi: 10.1016/S1470-2045(06)70804-X.'}, {'pmid': '16957145', 'type': 'RESULT', 'citation': 'Olaussen KA, Dunant A, Fouret P, Brambilla E, Andre F, Haddad V, Taranchon E, Filipits M, Pirker R, Popper HH, Stahel R, Sabatier L, Pignon JP, Tursz T, Le Chevalier T, Soria JC; IALT Bio Investigators. DNA repair by ERCC1 in non-small-cell lung cancer and cisplatin-based adjuvant chemotherapy. N Engl J Med. 2006 Sep 7;355(10):983-91. doi: 10.1056/NEJMoa060570.'}, {'pmid': '36090637', 'type': 'DERIVED', 'citation': 'Park CK, Oh HJ, Yoo SS, Lee SY, Lee SH, Kim EY, Lee SY, Choi J, Lee MK, Kim MH, Jang TW, Chung C, Oh IJ, Kim YC. Open-label, multi-center, phase II study of adjuvant pemetrexed plus cisplatin for completely resected stage IB to IIIA adenocarcinoma of the lung: APICAL trial. Transl Lung Cancer Res. 2022 Aug;11(8):1606-1618. doi: 10.21037/tlcr-22-183.'}]}, 'descriptionModule': {'briefSummary': 'Two-Year Disease Free Survival Rate of Stage IB\\~IIIA adenocarcinoma after Adjuvant Chemotherapy with Pemetrexed and Cisplatin will be assessed. A total of 106 patients will be recruited for 12 months, and followed for two years, thus the duration of study will be 36 months.', 'detailedDescription': 'Primary endpoint : 2 year disease free survival\n\nSecondary endpoints:\n\nOverall survival, Frequency and severity of adverse events'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adenocarcinoma of Lung\n* Postoperative pathologic stage IB\\~IIIA\n* Complete surgical resection (R0 resection) N1-2: R0 resection with lobectomy and mediastinal lymph nodes dissection (MLND) N0: R0 resection with lobectomy with or without MLND\n* Adjuvant treatment should start between 4 to 6 weeks after surgery\n* ECOG performance status 0-1\n* Weight loss during last 3 months should be less than 10%.\n* Normal hematologic, hepatic and renal function Neutrophil count \\> 1500 /microliter, Platelet \\> 100,000/microliter, Hemoglobin \\> 9 g/dL Bilirubin \\<=1.5 x upper limit normal, transaminase \\< 2.5 x upper limit normal Serum Creatinine \\<=1.5 mg/dL\n* Women in child bearing age should consent using contraceptive measures, and must have negative pregnancy test.\n\nExclusion Criteria:\n\n* Other malignant neoplastic disease within 5 years.\n* Neoadjuvant chemotherapy before surgery of lung cancer\n* Patients who will be treated with postoperative radiation.\n* Stage IIIB or IV lung cancer\n* Severe infection, or cardiorespiratory, hematologic illness\n* HIV positive cases\n* Pregnancy or lactating women\n* Autoimmune diseases or those who receiving immune suppressive treatment\n* Symptomatic neuropathy \\> CTCAE grade 1\n* Those who consented other clinical trials within 3 months\n* Other significant medical conditions contraindicated to clinical trial'}, 'identificationModule': {'nctId': 'NCT02498860', 'acronym': 'APICAL', 'briefTitle': 'Efficacy and Safety of Adjuvant Pemetrexed Plus Cisplatin for Adenocarcinoma of Lung', 'organization': {'class': 'OTHER', 'fullName': 'Chonnam National University Hospital'}, 'officialTitle': 'Efficacy and Safety of Pemetrexed Plus Cisplatin as Combination Chemotherapy for Post-operative Adenocarcinoma : Multi-center, Single Arm, Open-label, Phase Ⅱ Trial', 'orgStudyIdInfo': {'id': 'CNUHH-2015-7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pemebit plus Cisplatin', 'description': 'Pemetrexed (Pemebit 500 mg/m2) plus cisplatin (75 mg/m2) every 3 weeks up to 4 cycles', 'interventionNames': ['Drug: Pemebit', 'Drug: Cisplatin']}], 'interventions': [{'name': 'Pemebit', 'type': 'DRUG', 'otherNames': ['Pemetrexed'], 'description': '500mg/m2 on day 1 of every 3-week cycle, for a maximum of 4 cycles', 'armGroupLabels': ['Pemebit plus Cisplatin']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': '75mg/m2 on day 1 of every 3-week cycle, for a maximum of 4 cycles', 'armGroupLabels': ['Pemebit plus Cisplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '519-763', 'city': 'Hwasun', 'state': 'Jeollanam-do', 'country': 'South Korea', 'facility': 'Chonnam National University Hwasun Hospital', 'geoPoint': {'lat': 35.06125, 'lon': 126.98746}}, {'city': 'Daegu', 'state': 'Kyungpook', 'country': 'South Korea', 'facility': 'Kyungpook National University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '602-739', 'city': 'Pusan', 'country': 'South Korea', 'facility': 'Pusan National University Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Pusan', 'country': 'South Korea', 'facility': 'Kosin University Gospel Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea university Guro hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Young-Chul Kim, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Chonnam National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chonnam National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kosin University Gospel Hospital', 'class': 'OTHER'}, {'name': 'Korea University Guro Hospital', 'class': 'OTHER'}, {'name': 'Severance Hospital', 'class': 'OTHER'}, {'name': 'Chungnam National University Hospital', 'class': 'OTHER'}, {'name': 'Kyungpook National University Hospital', 'class': 'OTHER'}, {'name': 'Pusan National University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Young-Chul Kim', 'investigatorAffiliation': 'Chonnam National University Hospital'}}}}