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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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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
2023
Completed Phase 2
~420
Microwave Ablation
2021
Completed Phase 2
~1650
Chemotherapy
2003
Completed Phase 4
~3050
Computed Tomography
2017
Completed Phase 2
~2740
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Positron Emission Tomography
2011
Completed Phase 2
~2200

Find a Location

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor
515 Previous Clinical Trials
219,512 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,878 Previous Clinical Trials
41,012,685 Total Patients Enrolled

Media Library

Chemotherapy (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05673148 — Phase 3
Colorectal Cancer Research Study Groups: Arm 1 (TAT, SOC chemotherapy, Arm 2 (SOC chemotherapy)
Colorectal Cancer Clinical Trial 2023: Chemotherapy Highlights & Side Effects. Trial Name: NCT05673148 — Phase 3
Chemotherapy (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05673148 — Phase 3
~243 spots leftby Jun 2028