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Chemotherapy
Ablative Therapy + Systemic Therapy for Colorectal Cancer
Phase 3
Recruiting
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial compares using intense local treatment to the usual approach of using only intravenous and/or oral medications to treat colorectal cancer spread to up to 4 sites.
Who is the study for?
Adults with colorectal cancer spread to up to 4 sites, excluding the brain and peritoneum. Must have had or be eligible for primary tumor resection, no more than 6 months of systemic therapy without disease progression, and meet specific health criteria like adequate blood counts and liver function.
What is being tested?
The trial is comparing usual systemic therapy (like IV chemotherapy) alone versus adding total ablative therapy (intense radiotherapy called SABR, possibly combined with surgery or microwave ablation) to see if it better controls cancer that has spread in a limited way.
What are the potential side effects?
Potential side effects include typical reactions from radiotherapy such as skin irritation, fatigue, nausea; surgical complications like infection; microwave ablation risks including pain at the treatment site and damage to nearby organs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Survival (OS)
Secondary study objectives
Event Free Survival (EFS)
Time to local recurrence (TLR)
• Incidence of Adverse Events (AEs), assessed using National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 (v5.0)
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1 (TAT, SOC chemotherapyExperimental Treatment7 Interventions
Patients undergo TAT on study, consisting of SABR with or without surgical resection and/or microwave ablation. Patients also receive SOC chemotherapy on study. Patients also undergo CT or MRI or PET/CT scans throughout the trial.
Group II: Arm 2 (SOC chemotherapy)Active Control4 Interventions
Patients receive SOC chemotherapy on study. Patients also undergo Patients also undergo CT or MRI or PET/CT scans throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Resection
2020
Completed Phase 2
~1440
Microwave Ablation
2021
Completed Phase 2
~1650
Chemotherapy
2003
Completed Phase 4
~3050
Computed Tomography
2017
Completed Phase 2
~2790
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Positron Emission Tomography
2011
Completed Phase 2
~2200
Find a Location
Who is running the clinical trial?
Alliance for Clinical Trials in OncologyLead Sponsor
518 Previous Clinical Trials
221,973 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,111,753 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer did not worsen while on my last treatment.My primary tumor has been removed or can be surgically removed.My cancer does not have the BRAF V600E mutation.I am able to get out of my bed or chair and move around.I am HIV-positive, on treatment, and my viral load is undetectable.I am 18 years old or older.My tumor is not MSI-high.My brain cancer has not worsened after treatment.My cancer has not spread to the lining of my abdomen or the fat layer.My cancer has spread to 4 or fewer places in my body.I have had up to 4 months of systemic therapy before joining.My cancer is a type of colorectal cancer that has spread.My kidney function, measured by creatinine levels, is within the normal range.I've been on first-line treatment for my metastatic disease for 4 to 6 months.My last cancer treatment was over a year ago before my cancer spread.I am not a candidate for or unsure of the benefits from HAIP therapy.My cancer that has spread can be treated with surgery or targeted therapies.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1 (TAT, SOC chemotherapy
- Group 2: Arm 2 (SOC chemotherapy)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.