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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
No overt evidence of disease progression during systemic therapy prior to registration
No known BRAF V600E mutation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer did not worsen while on my last treatment.
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My cancer does not have the BRAF V600E mutation.
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I am able to get out of my bed or chair and move around.
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I am 18 years old or older.
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My tumor is not MSI-high.
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My primary tumor has been removed or can be surgically removed.
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My cancer has not spread to the lining of my abdomen or the fat layer.
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My cancer has spread to 4 or fewer places in my body.
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I am not a candidate for or unsure of the benefits from HAIP therapy.
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I have had up to 4 months of systemic therapy before joining.
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My cancer is a type of colorectal cancer that has spread.
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My kidney function, measured by creatinine levels, is within the normal range.
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My cancer that has spread can be treated with surgery or targeted therapies.
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My last cancer treatment was over a year ago before my cancer spread.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
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)

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
2021
Completed Phase 2
~410
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
2008
Completed Phase 2
~2260

Find a Location

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,270 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,926,983 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many venues is this research project being conducted?

"Currently, 11 physical trial sites are available to participate in this clinical study. These locations range from Gainesville to Des Moines and everywhere in between. It is recommended for participants to choose the site closest geographically so as not to overextend themselves with too much travel."

Answered by AI

What potential risks can be associated with Arm 1 (TAT, SOC chemotherapy)?

"Arm 1 (TAT, SOC chemotherapy) has a safety rating of 3 due to the prior research data illustrating its efficacy and multiple rounds proving its security."

Answered by AI

Are there any openings for participants in this exploration?

"Confirmed. Clinicaltrials.gov reveals that this medical research, which was first listed on October 1st 2023, is currently in the process of recruiting participants. A total of 364 individuals are needed from 11 different facilities."

Answered by AI

How many people are currently participating in the research program?

"Correct. The clinical trial's posting on clinicialtrials.gov confirms that it is presently accepting patients. This research project was initially posted on 10th of January 2023 and its most recent edit was conducted in April 14th 2023, with the aim to recruit 364 individuals from 11 distinct medical centres."

Answered by AI
~243 spots leftby Jun 2028