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Procedure
Ablative Therapy for Gastrointestinal Cancer (LIVELONG Trial)
N/A
Recruiting
Led By Edward Kim, MD, PhD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18 years at time of consent.
≤ 5 progressing or new metastatic lesions.
Must not have
History of treatment related toxicities that limit or prohibit application of locally ablative therapies.
Progressing intracranial lesions.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years from the first day of ablative local therapy
Awards & highlights
No Placebo-Only Group
Summary
This trial studies the benefit of adding locally ablative therapies to systemic therapy for solid tumors that have not spread widely. Outcome measure is time to treatment failure.
Who is the study for?
The LIVELONG trial is for adults over 18 with certain gastrointestinal cancers, like colorectal or stomach cancer, who have seen benefits from their current systemic therapy. They should have no more than five new or worsening metastatic lesions and be able to continue their present treatment after a short break for local therapy.
What is being tested?
This phase 2 study tests if adding local ablative therapies (targeted treatments to destroy tumors) to ongoing systemic therapy can extend the time before treatment fails in patients with limited progression of gastrointestinal cancers.
What are the potential side effects?
While specific side effects are not listed, locally ablative therapies may include risks such as pain at the treatment site, fatigue, skin reactions, and potential damage to nearby organs or tissues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have 5 or fewer new or growing cancer spots.
Select...
My cancer is in the colon, rectum, or appendix.
Select...
My cancer type has been confirmed through testing.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have side effects from past treatments that prevent me from getting certain local therapies.
Select...
My brain tumor is getting worse.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years from the first day of ablative local therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years from the first day of ablative local therapy
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with controlled disease
Secondary study objectives
Median overall survival
Number of participants experiencing grade ≥ 3 adverse events attributable to ablative local therapy
Time to treatment failure
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ablative local therapyExperimental Treatment1 Intervention
Stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy
Find a Location
Who is running the clinical trial?
University of California, DavisLead Sponsor
946 Previous Clinical Trials
4,755,830 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,111,787 Total Patients Enrolled
Edward Kim, MD, PhDPrincipal InvestigatorUniversity of California, Davis
1 Previous Clinical Trials
96 Total Patients Enrolled