Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2025-12-28 @ 7:05 AM
Study NCT ID:
NCT01453257
Status:
COMPLETED
Last Update Posted:
2011-10-19
First Post:
2011-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Target-Guided Chemotherapy in Metastatic Colorectal Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-18', 'studyFirstSubmitDate': '2011-10-13', 'studyFirstSubmitQcDate': '2011-10-14', 'lastUpdatePostDateStruct': {'date': '2011-10-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Complete Response Rate', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Molecular Targets', 'Personalize Treatment', 'Colon Cancer', 'Complete Response Rate'], 'conditions': ['Progression Free Survival']}, 'descriptionModule': {'briefSummary': 'Treatment options for patients with colorectal cancer (CRC) have increased in the last years. However, there are no validated prospective molecular markers in CRC to select which agents are better to treat any individual case. The conventional first-line treatment in CRC patients in clinical studies get a proportion of patients free of progression at 12 months ranging from 35-40% with a median of 9 months of free disease progression.\n\nThe aim of this study is to demonstrate that the identification of therapeutic targets in real time and their prospectively use to customize the treatment get a proportion of colorectal metastatic patients patients free of progression disease at 12 months of 50%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Colorectal adenocarcinoma stage IV patients.\n* ECOG= 0-1\n* Age \\> 18 years.\n* Fit to receive chemotherapy treatment\n* Availability of tumor tissue or possibility of a tumor biopsy to determine therapeutic targets.\n* Adequate renal (Cr \\< 1,5 mg/d), liver (bilirubin≤1,5 mg/dl, AST and ALT ≤ 3.0 x the upper limit of normal) and normal bone marrow function ( absolute neutrophil count ≥ 1500/µl, hemoglobin ≥ 9.0g/dl and a platelet count of ≥ 100.000/µl)\n\nExclusion Criteria:\n\n* Contraindication for the administration of any of the drugs used in the study including capecitabine, irinotecan, oxaliplatin, cetuximab or bevacizumab.\n* Previous Chemotherapy treatment'}, 'identificationModule': {'nctId': 'NCT01453257', 'acronym': 'TT', 'briefTitle': 'Study of Target-Guided Chemotherapy in Metastatic Colorectal Patients', 'organization': {'class': 'OTHER', 'fullName': 'Grupo Hospital de Madrid'}, 'officialTitle': 'A Phase 2 Study of Target-Guided Personalized Chemotherapy in Metastatic Colorectal Cancer Patients', 'orgStudyIdInfo': {'id': 'C62 202-878'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chemotherapy treatment', 'description': 'Tailored chemotherapy by Therapeutic Targets', 'interventionNames': ['Drug: Tailored Chemotherapy']}], 'interventions': [{'name': 'Tailored Chemotherapy', 'type': 'DRUG', 'otherNames': ['Biomarker selection', 'Therapeutic Targets chemotherapy'], 'description': 'Patients will be treated with Folfox, Folfiri, Xelox or Xeliri and Cetuximab or Bevacizumab at usual doses tailored by:\n\nK-ras native: Cetuximab. K-ras mutated: Bevacizumab Topoisomera 1 positive ( Topo-1): Irinotecan Topo-1 positive and ERCC-1 negative: oxaliplatin Topo-1 1 negative and ERCC-1 positive: investigator option Thimidylate synthase (TS) positive: No Fluoropyrimidines (FLP) TS negative: FLP Thimidylate phosphorylasa (TP) positive: Capecitabine TP negative: 5-FU', 'armGroupLabels': ['Chemotherapy treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28050', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Centro Integral Oncológico Clara campal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Antonio Cubillo, Md PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Grupo Hospital madrid'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grupo Hospital de Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Fundación Hospital de mADRID', 'investigatorFullName': 'Sofia Perea, PharmD, PhD', 'investigatorAffiliation': 'Grupo Hospital de Madrid'}}}}