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ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases

Primary Purpose

Liver Metastases

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Leucovorin
5-FLUOROURACIL
Oxaliplatin
Irinotecan
Capecitabine
Bevacizumab
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ctDNA (Low Risk)

ctDNA (High Risk)

Arm Description

Will receive less intense chemotherapy, such as capecitabine or 5-fluorouracil.

Will receive more intense chemotherapy. This may include resuming the chemotherapy you received before surgery (for example, FOLFOX [5-fluorouracil, leucovorin and oxaliplatin] or FOLFIRI [5-fluorouracil, leucovorin and irinotecan] with or without bevacizumab)

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
September 21, 2021
Last Updated
October 6, 2023
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05062317
Brief Title
ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases
Official Title
Risk-Stratified Adjuvant Therapy: ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2022 (Actual)
Primary Completion Date
February 28, 2026 (Anticipated)
Study Completion Date
February 28, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ctDNA (Low Risk)
Arm Type
Experimental
Arm Description
Will receive less intense chemotherapy, such as capecitabine or 5-fluorouracil.
Arm Title
ctDNA (High Risk)
Arm Type
Experimental
Arm Description
Will receive more intense chemotherapy. This may include resuming the chemotherapy you received before surgery (for example, FOLFOX [5-fluorouracil, leucovorin and oxaliplatin] or FOLFIRI [5-fluorouracil, leucovorin and irinotecan] with or without bevacizumab)
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Other Intervention Name(s)
Citrovorum, Wellcovorin®
Intervention Description
Given by PO
Intervention Type
Drug
Intervention Name(s)
5-FLUOROURACIL
Intervention Description
Given by IV
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
Eloxatin
Intervention Description
Given by PO
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
Given by IV
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
Given by IV
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin™, Anti-VEGF monoclonal antibody, rhuMAb-VEGF
Intervention Description
Given by IV
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Timothy Newhook
Phone
(713) 794-1001
Email
tnewhook@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Newhook
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy Newhook
Phone
713-794-1001
Email
tnewhook@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Timothy Newhook

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center website

Learn more about this trial

ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases

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