ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Leucovorin, 5-FLUOROURACIL, Oxaliplatin, Irinotecan.
- Who it may be relevant to
- Registry conditions: Liver Metastases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Risk-Stratified Adjuvant Therapy: ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases
Overview
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.
Detailed description
Primary Objective:
• 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
Secondary Objectives:
* To assess recurrence-free survival following liver resection of CLM with curative intent among ctDNA-positive patients * To assess overall survival following liver resection among ctDNA-negative and ctDNA-positive patients * To evaluate the proportion of ctDNA-negative at 1-year post-resection * To compare survival of ctDNA-negative patients undergoing ctDNA-guided postoperative chemotherapy to historical controls * To evaluate proportion of patients in each arm who change chemotherapy in response to ctDNA measurement * To delineate the pattern of disease recurrence * To assess ctDNA sensitivity and specificity for predicting disease recurrence * To evaluate MDASI-GI during the course of postoperative therapy * To evaluate and correlate patient molecular subtypes and characterization of tumor biologic factors that are associated with ctDNA detection * 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
Outcome Measures:
Primary:
• Recurrence-free survival at 1-year post-hepatectomy among ctDNA-negative patients
Secondary:
* Recurrence-free survival at 1-year post-hepatectomy among ctDNA-positive patients * Overall survival (OS) among ctDNA-negative and ctDNA-positive patients * ctDNA-negativity at 1-year post-resection * Proportion of patients in each group with chemotherapy regimen change in response to ctDNA dynamics * Pattern of disease recurrence (i.e., liver, systemic, salvageable vs. unsalvageable) * ctDNA sensitivity/specificity for recurrent disease overall by timepoint * MDASI-GI at clinic visits during course of postoperative therapy * Tumor radiologic, histologic, and molecular profiling and correlative characterization based upon ctDNA detection * Adverse events
Interventions
- Drug Leucovorin
Given by PO - Drug 5-FLUOROURACIL
Given by IV - Drug Oxaliplatin
Given by PO - Drug Irinotecan
Given by IV - Drug Capecitabine
Given by IV - Drug Bevacizumab
Given by IV
Primary outcome measures
- 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 [Time frame: through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
- 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/FOLFIRI +/- bevacizumab or panitumumab/cetuximab) from 07/01/2021 - 12/31/2023
- Must receive ≥ 4 cycles of preoperative chemotherapy
Exclusion criteria
- Patients with primary colorectal tumor that will remain in situ
- Inability to undergo postoperative chemotherapy, or postoperative chemotherapy not planned a priori
- Unwilling/unable to undergo blood draws for ctDNA, patient or provider-determined
- Other active malignancies requiring treatment
- Women who are pregnant
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- M D Anderson Cancer Center — Houston
Identifiers
NCT: NCT05062317 · 2021-0584 · NCI-2021-10706