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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05062317
Phase
PHASE2
Status
Recruiting
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Conditions

  • Liver Metastases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Leucovorin — DRUG
    Given by PO
  • 5-FLUOROURACIL — DRUG
    Given by IV
  • Oxaliplatin — DRUG
    Given by PO
  • Irinotecan — DRUG
    Given by IV
  • Capecitabine — DRUG
    Given by IV
  • Bevacizumab — DRUG
    Given by IV

Study Details

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.

Key Dates

Start date
Apr 26, 2022
Status verified
Feb 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ctDNA (Low Risk)
    Will receive less intense chemotherapy, such as capecitabine or 5-fluorouracil.
  • Experimental: ctDNA (High Risk)
    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)

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Timothy Newhook
[email protected]
713-794-1001
Timothy Newhook (PRINCIPAL_INVESTIGATOR)

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By research site
M D Anderson Cancer Center· Houston, TX

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