Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-26 @ 1:33 AM
Study NCT ID:
NCT01023633
Status:
UNKNOWN
Last Update Posted:
2009-12-02
First Post:
2009-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
OPTIMOX1 in Chinese mCRC Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D005472', 'term': 'Fluorouracil'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-12-01', 'studyFirstSubmitDate': '2009-12-01', 'studyFirstSubmitQcDate': '2009-12-01', 'lastUpdatePostDateStruct': {'date': '2009-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DDC: Duration of Disease Control', 'timeFrame': 'Oct2012'}], 'secondaryOutcomes': [{'measure': 'OS, RR, PFS, DCR, safety,', 'timeFrame': 'Oct 2015'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['to investigate the efficacy and feasibility of this novel treatment strategy in Chinese mCRC patients', 'Primary Endpoint:DDC', 'Secondary Endpoint:OS, RR,DCR, PFS,safety'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '16421419', 'type': 'RESULT', 'citation': 'Tournigand C, Cervantes A, Figer A, Lledo G, Flesch M, Buyse M, Mineur L, Carola E, Etienne PL, Rivera F, Chirivella I, Perez-Staub N, Louvet C, Andre T, Tabah-Fisch I, de Gramont A. OPTIMOX1: a randomized study of FOLFOX4 or FOLFOX7 with oxaliplatin in a stop-and-Go fashion in advanced colorectal cancer--a GERCOR study. J Clin Oncol. 2006 Jan 20;24(3):394-400. doi: 10.1200/JCO.2005.03.0106.'}]}, 'descriptionModule': {'briefSummary': 'Previous OPTIMOX1 study investigated the use of oxaliplatin discontinuation and reintroduction in a novel stop-and-go strategy. Previously untreated patients were randomly assigned to either FOLFOX4 administered every 2 weeks until progression (arm A) or FOLFOX7 for 6 cycles, maintenance without oxaliplatin for 12 cycles, and reintroduction of FOLFOX7 for another 6 cycles (arm B). Data showed that there was no significant difference in median progression-free survival (PFS) and overall survival (OS) between two arms. Furthermore, this study showed lower Grade 3 neurotoxicity rate in arm B (17.9% vs 13.3%, P = 0.12).In order to investigate the efficacy and feasibility of the novel "Stop and go" strategy in Chinese mCRC patients, Prof. Shu Yongqian in JiangShu Province Hospital plans to conduct a randomized controlled study to compare continuous FOLFOX4 vs. FOLFOX4 in a Stop-and-Go Fashion in 1st Line mCRC patients. To avoid the high oxaliplatin dosage related neurotoxicity, FOLFOX4 regimen is chosen in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with histologically confirmed adenocarcinoma of the colon or rectum\n* Unresectable metastases\n* At least one bidimensionally measurable lesion of ≥ 1 cm\n* No previous chemotherapy for metastatic disease; Completed at least more than 1 year oxaliplatin therapy for adjuvant treatment\n* 18-75 years old\n* ECOG 0-2\n* Life expectancy greater than 3 months\n* Hemogram: WBC≥4.0 X109/L, ANC ≥2 X109/L, PLT ≥100 X109/L, Hb ≥90g/L,\n* Adequate Renal Function\n* Adequate Liver Function\n* Signed informed consent before the treatment\n\nExclusion Criteria:\n\n* Patients with previous oxaliplatin based adjuvant chemotherapy within 1 Year\n* Completely or partially bowel obstruction\n* Presence of peripheral neuropathy (CTC\\>grade I)\n* Severe mental disorder\n* CNS metastasis\n* With other severe disease: uncontrolled active infectious disease, uncontrolled hypertension, heart infarction within 1 year, uncontrolled high-risk arrhythmia, unstable angina\n* With other malignant disease previously or concurrently\n* Receive other anti-tumor treatment\n* Pregnant or lactating women, or women of child bearing potential without contraceptive method.'}, 'identificationModule': {'nctId': 'NCT01023633', 'briefTitle': 'OPTIMOX1 in Chinese mCRC Patients', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing Medical University'}, 'officialTitle': 'A Randomized Study Of Continuous FOLFOX4 vs. FOLFOX4 in a Stop-and-Go Fashion in 1st Line Advanced Colorectal Cancer', 'orgStudyIdInfo': {'id': 'Oxali04882'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm A: FOLFOX 4 continuous (Oxaliplatin, LV, 5-FU)', 'description': 'The arm A (FOLFOX4 continuous arm):receive FOLFOX4 every 2 weeks until progression or for maximum 24 cycles.', 'interventionNames': ['Drug: Oxaliplatin, LV, 5-FU']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B: FOLFOX4 Stop and go (Oxaliplatin, LV, 5-FU)', 'description': 'The arm B will receive FOLFOX4 for 6 cycles, maintenance with 5FU/LV for 12 cycles, and reintroduction of FOLFOX4 for 6 cycles', 'interventionNames': ['Drug: Oxaliplatin, LV, 5-FU']}], 'interventions': [{'name': 'Oxaliplatin, LV, 5-FU', 'type': 'DRUG', 'otherNames': ['Eloxatin'], 'description': 'Arm B(Intervention arm) will receive FOLFOX4 for 6 cycles, maintenance with 5FU/LV for 12 cycles, and reintroduction of FOLFOX4 for 6 cycles.\n\nFOLFOX4 regimen:\n\nOXA 85mg/m2 , 2 hour infusion, d1 , Leucovorin 200 mg/m2 plus 5-FU 400mg IV bolus, then continuous 22 hour 600 mg/m2 infusion on day 1 and 2 Q2W', 'armGroupLabels': ['Arm A: FOLFOX 4 continuous (Oxaliplatin, LV, 5-FU)', 'Arm B: FOLFOX4 Stop and go (Oxaliplatin, LV, 5-FU)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaofeng Chen, MD', 'role': 'CONTACT', 'email': 'xiaofengch198019@126.com', 'phone': '86 25 83718836', 'phoneExt': '6428'}, {'name': 'Yongqian Shu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The 1st Affiliated Hospital Of NanJing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '310016', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongming Pan, MD', 'role': 'CONTACT', 'email': 'panhongming@tom.com', 'phone': '0571-86090073'}, {'name': 'Hongming Pan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhejiang University affiliated sir run run shaw hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Yongqian Shu, MD', 'role': 'CONTACT', 'email': 'shuyongqian@csco.org.cn', 'phone': '86 25 83718836', 'phoneExt': '6428'}, {'name': 'Xiaofeng Chen, MD', 'role': 'CONTACT', 'email': 'xiaofengch198019@126.com', 'phone': '86 25 83718836', 'phoneExt': '6428'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Nanjing Medical University.', 'oldOrganization': 'Nanjing Medical University'}}}}