[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05062317":3,"trial-entities:NCT05062317":113,"trial-summary:NCT05062317":118},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":63,"secondary_outcomes":67,"sex":68,"minimum_age":69,"maximum_age":70,"healthy_volunteers":15,"eligibility_criteria":71,"std_ages":82,"locations":85,"central_contacts":103,"overall_officials":106,"references":108,"see_also_links":109},"NCT05062317","2021-0584","ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases","Risk-Stratified Adjuvant Therapy: ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases","RECRUITING","2027-02-28","2026-07","2026-07-14","2022-04-26","M.D. Anderson Cancer Center","OTHER",false,"To determine if the detection of ctDNA after surgical resection of CLM can stratify patients into high and low-risk cohorts for early disease recurrence in order to inform post-operative adjuvant therapy.","Primary Objective:\n\n• To assess 1-year recurrence-free survival rate following liver resection of CLM with curative intent among ctDNA-negative patients who receive risk-stratified postoperative chemotherapy\n\nSecondary Objectives:\n\n* To assess recurrence-free survival following liver resection of CLM with curative intent among ctDNA-positive patients\n* To assess overall survival following liver resection among ctDNA-negative and ctDNA-positive patients\n* To evaluate the proportion of ctDNA-negative at 1-year post-resection\n* To compare survival of ctDNA-negative patients undergoing ctDNA-guided postoperative chemotherapy to historical controls\n* To evaluate proportion of patients in each arm who change chemotherapy in response to ctDNA measurement\n* To delineate the pattern of disease recurrence\n* To assess ctDNA sensitivity and specificity for predicting disease recurrence\n* To evaluate MDASI-GI during the course of postoperative therapy\n* To evaluate and correlate patient molecular subtypes and characterization of tumor biologic factors that are associated with ctDNA detection\n* To evaluate surgery-related adverse events occurring up to 90 days after surgery, and chemo-related adverse events occurring up to 30 days after the last dose of chemotherapy\n\nOutcome Measures:\n\nPrimary:\n\n• Recurrence-free survival at 1-year post-hepatectomy among ctDNA-negative patients\n\nSecondary:\n\n* Recurrence-free survival at 1-year post-hepatectomy among ctDNA-positive patients\n* Overall survival (OS) among ctDNA-negative and ctDNA-positive patients\n* ctDNA-negativity at 1-year post-resection\n* Proportion of patients in each group with chemotherapy regimen change in response to ctDNA dynamics\n* Pattern of disease recurrence (i.e., liver, systemic, salvageable vs. unsalvageable)\n* ctDNA sensitivity\u002Fspecificity for recurrent disease overall by timepoint\n* MDASI-GI at clinic visits during course of postoperative therapy\n* Tumor radiologic, histologic, and molecular profiling and correlative characterization based upon ctDNA detection\n* Adverse events",[19],"Liver Metastases",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE2",{"count":26,"type":27},120,"ESTIMATED",[29,39,43,48,51,56],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":36},"DRUG","Leucovorin","Given by PO",[34,35],"ctDNA (High Risk)","ctDNA (Low Risk)",[37,38],"Citrovorum","Wellcovorin®",{"type":30,"name":40,"description":41,"armGroupLabels":42},"5-FLUOROURACIL","Given by IV",[34],{"type":30,"name":44,"description":32,"armGroupLabels":45,"otherNames":46},"Oxaliplatin",[34],[47],"Eloxatin",{"type":30,"name":49,"description":41,"armGroupLabels":50},"Irinotecan",[34],{"type":30,"name":52,"description":41,"armGroupLabels":53,"otherNames":54},"Capecitabine",[34,35],[55],"Xeloda",{"type":30,"name":57,"description":41,"armGroupLabels":58,"otherNames":59},"Bevacizumab",[34],[60,61,62],"Avastin™","Anti-VEGF monoclonal antibody","rhuMAb-VEGF",[64],{"measure":65,"timeFrame":66},"To establish the 1-year recurrence-free survival rate following liver resection of CLM with curative intent among ctDNA-negative patients who receive risk-stratified postoperative chemotherapy","through study completion, an average of 1 year",[],"ALL","18 Years",null,{"inclusion":72,"exclusion":75,"raw_text":81},[73,74],"Patients ≥18 years of age with CLM undergoing elective hepatectomy with curative intent (primary colorectal primary cancer previously removed OR being removed at time of hepatectomy) after preoperative chemotherapy (i.e., FOLFOX\u002FFOLFIRI +\u002F- bevacizumab or panitumumab\u002Fcetuximab) from 07\u002F01\u002F2021 - 12\u002F31\u002F2023","Must receive ≥ 4 cycles of preoperative chemotherapy",[76,77,78,79,80],"Patients with primary colorectal tumor that will remain in situ","Inability to undergo postoperative chemotherapy, or postoperative chemotherapy not planned a priori","Unwilling\u002Funable to undergo blood draws for ctDNA, patient or provider-determined","Other active malignancies requiring treatment","Women who are pregnant","Inclusion Criteria:\n\n* Patients ≥18 years of age with CLM undergoing elective hepatectomy with curative intent (primary colorectal primary cancer previously removed OR being removed at time of hepatectomy) after preoperative chemotherapy (i.e., FOLFOX\u002FFOLFIRI +\u002F- bevacizumab or panitumumab\u002Fcetuximab) from 07\u002F01\u002F2021 - 12\u002F31\u002F2023\n* Must receive ≥ 4 cycles of preoperative chemotherapy\n\nExclusion Criteria:\n\n* Patients with primary colorectal tumor that will remain in situ\n* Inability to undergo postoperative chemotherapy, or postoperative chemotherapy not planned a priori\n* Unwilling\u002Funable to undergo blood draws for ctDNA, patient or provider-determined\n* Other active malignancies requiring treatment\n* Women who are pregnant",[83,84],"ADULT","OLDER_ADULT",[86],{"facility":87,"status":8,"city":88,"state":89,"zip":90,"country":91,"contacts":92,"geoPoint":100},"M D Anderson Cancer Center","Houston","Texas","77030","United States",[93,98],{"name":94,"role":95,"phone":96,"email":97},"Timothy Newhook","CONTACT","713-794-1001","tnewhook@mdanderson.org",{"name":94,"role":99},"PRINCIPAL_INVESTIGATOR",{"lat":101,"lon":102},29.76328,-95.36327,[104],{"name":94,"role":95,"phone":105,"email":97},"(713) 794-1001",[107],{"name":94,"affiliation":13,"role":99},[],[110],{"label":111,"url":112},"M D Anderson Cancer Center website","http:\u002F\u002Fwww.mdanderson.org",{"nct_id":4,"conditions":114,"biomarkers":117},[115,116],"Colorectal Carcinoma","Metastatic Malignant Neoplasm in the Liver",[],{"nct_id":4,"found":119,"summary":120,"prompt_version":130},true,{"design":121,"status":122,"heading":123,"summary":124,"follow_up":125,"word_count":126,"commitments":127,"compensation":128,"drugs_mentioned":129},"This is an interventional study planning to enroll 120 participants. The phase of the study is not specified.","completed","ctDNA-Directed Chemotherapy for Colorectal Liver Metastases","This study is looking at how to best treat colorectal cancer that has spread to the liver (colorectal liver metastases or CLM) after surgery. Researchers want to see if using a blood test for circulating tumor DNA (ctDNA) can help decide who needs more chemotherapy after their liver surgery. The study will use common chemotherapy drugs like Leucovorin, 5-FLUOROURACIL, Oxaliplatin, Irinotecan, and Capecitabine. You might be able to join if you are at least 18 years old, have CLM, are having liver surgery with the goal of cure, and have already received at least 4 cycles of chemotherapy before your surgery. The main goal is to see how many patients are free of cancer recurrence one year after surgery, especially those who are ctDNA-negative and receive chemotherapy based on their risk.","Participants will be followed through study completion, which is an average of one year, to assess recurrence-free survival.",131,"Not specified in the trial record.","Not stated in the trial record.",[31,40,44,49,52],"v2"]