Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-01 @ 9:51 PM
Study NCT ID:
NCT04513457
Status:
COMPLETED
Last Update Posted:
2021-03-29
First Post:
2020-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chemotherapy for Resectable Colorectal Liver Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D008113', 'term': 'Liver 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'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006498', 'term': 'Hepatectomy'}, {'id': 'D020360', 'term': 'Neoadjuvant Therapy'}, {'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 967}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-26', 'studyFirstSubmitDate': '2020-08-11', 'studyFirstSubmitQcDate': '2020-08-13', 'lastUpdatePostDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival based on perioperative treatment', 'timeFrame': '5 years of follow-up', 'description': 'Overall survival based on perioperative treatment'}, {'measure': 'Cancer survival based on perioperative treatment', 'timeFrame': '5 years of follow-up', 'description': 'Cancer survival based on perioperative treatment'}, {'measure': 'Disease-free survival based on perioperative treatment', 'timeFrame': '5 years of follow-up', 'description': 'Disease-free survival based on perioperative treatment'}, {'measure': 'Peri-operative morbidity', 'timeFrame': '5 years of follow-up', 'description': 'Peri-operative morbidity'}, {'measure': 'Peri-operative mortality', 'timeFrame': '5 years of follow-up', 'description': 'Peri-operative mortality'}], 'secondaryOutcomes': [{'measure': 'Overall survival, cancer survival and disease-free survival related with biological markers', 'timeFrame': '5 years of follow-up', 'description': 'Overall survival, cancer survival and disease-free survival related with biological markers'}, {'measure': 'Overall survival, cancer survival and disease-free survival related with hidden no resected liver lesions.', 'timeFrame': '5 years of follow-up', 'description': 'Overall survival, cancer survival and disease-free survival related with hidden no resected liver lesions.'}, {'measure': 'Overall survival, cancer survival and disease-free survival based related with simultaneous thermal ablation performed at the same time of the surgical excision.', 'timeFrame': '5 years of follow-up', 'description': 'Overall survival, cancer survival and disease-free survival based related with simultaneous thermal ablation performed at the same time of the surgical excision.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colorectal liver metastases', 'Liver resection', 'Hepatectomy'], 'conditions': ['Metastatic Colorectal Cancer', 'Metastatic Liver Cancer']}, 'descriptionModule': {'briefSummary': 'There is a degree of uncertainty regarding the role of perioperative chemotherapy (CTx) in the treatment of resectable colorectal liver metastases (CRLM). In the clinical practice, the combination of surgery and CTx is increasingly accepted as treatment for CRLM, especially in the context of patients with synchronous disease or metachronous disease with a high risk of recurrence. However, controversy exists whether all patients with resectable CRLM benefit from perioperative CTx.\n\nThere is paucity of good quality studies on this topic. A pooled analysis of two phase III randomized clinical trial, closed prematurely because of slow accrual, showed a marginal statistical significance in favor of adjuvant CTx. Nevertheless, long term results of the EPOC trial founded benefit in disease free survival (DFS) with no difference in overall survival (OS) when perioperative CTx with FOLFOX4 was compared with surgery alone for resectable CRLM. Furthermore, a retrospective series from Ayez et al showed that patients with a high CRS benefit from neo-adjuvant CTx while in patients with a low risk profile did not. On the other side, another retrospective series from the MSKCC showed the timing of additional CTx for resectable CRLM was not associated with improved outcomes. The ongoing CHARISMA trial is currently comparing the outcomes of neo-adjuvant CTx followed by surgery versus surgery alone in high-risk patients with resectable CRLM.\n\nThis uncertainty regarding CRLM management may partly be due to the fact that these studies are not well powered to detect minor differences in long term outcomes and they often involved a very heterogenous group of patients with both synchronous and metachronous CRLM, not stratified by clinical risk score (CRS) as described by Fong et al.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients undergoing liver resection for colorectal metastases between January 1, 2010 and December 31, 2014, inclusive', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 18 years with resectable liver metastases of histologically confirmed primary colorectal carcinoma.\n* Minimum follow-up of five years.\n\nExclusion Criteria:\n\n* Patients with extrahepatic disease'}, 'identificationModule': {'nctId': 'NCT04513457', 'briefTitle': 'Chemotherapy for Resectable Colorectal Liver Metastases', 'organization': {'class': 'OTHER', 'fullName': 'Fundación de Investigación Biomédica - Hospital Universitario de La Princesa'}, 'officialTitle': 'Perioperative Chemotherapy Versus Surgery for Resectable Colorectal Liver Metastases: a Multicenter Propensity Score Matched Analysis on Long-term Outcomes', 'orgStudyIdInfo': {'id': 'Chemotherapy-liver-metastases'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Liver resection and Neoadjuvant chemotherapy', 'description': 'Liver resection and Neoadjuvant chemotherapy', 'interventionNames': ['Other: Liver resection and Neoadjuvant chemotherapy']}, {'label': 'Liver resection and Adjuvant chemotherapy', 'description': 'Liver resection and Adjuvant chemotherapy', 'interventionNames': ['Other: Liver resection and Adjuvant chemotherapy']}, {'label': 'Liver resection, Neoadjuvant and Adjuvant chemotherapy', 'description': 'Liver resection, Neoadjuvant chemotherapy and Adjuvant chemotherapy', 'interventionNames': ['Other: Liver resection, Neoadjuvant chemotherapy and Adjuvant chemotherapy']}, {'label': 'Liver resection', 'description': 'Liver resection', 'interventionNames': ['Procedure: Liver resection']}], 'interventions': [{'name': 'Liver resection and Neoadjuvant chemotherapy', 'type': 'OTHER', 'armGroupLabels': ['Liver resection and Neoadjuvant chemotherapy']}, {'name': 'Liver resection and Adjuvant chemotherapy', 'type': 'OTHER', 'armGroupLabels': ['Liver resection and Adjuvant chemotherapy']}, {'name': 'Liver resection, Neoadjuvant chemotherapy and Adjuvant chemotherapy', 'type': 'OTHER', 'armGroupLabels': ['Liver resection, Neoadjuvant and Adjuvant chemotherapy']}, {'name': 'Liver resection', 'type': 'PROCEDURE', 'armGroupLabels': ['Liver resection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Reims', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'city': 'Santander', 'state': 'Cantabria', 'country': 'Spain', 'facility': 'Hospital Universitario Marqués de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Badajoz', 'country': 'Spain', 'facility': 'Hospital Universitario de Badajoz', 'geoPoint': {'lat': 38.87789, 'lon': -6.97061}}, {'city': 'Girona', 'country': 'Spain', 'facility': 'Hospital Dr. Josep Trueta', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}, {'city': 'Jaén', 'country': 'Spain', 'facility': 'Hospital Universitario de Jaén', 'geoPoint': {'lat': 37.76922, 'lon': -3.79028}}, {'zip': '28006', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario de La Princesa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen de la Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Liverpool University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación de Investigación Biomédica - Hospital Universitario de La Princesa', 'class': 'OTHER'}, 'collaborators': [{'name': 'Marcello Di Martino', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}