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NCT05174169 · ClinicalTrials.gov registry record · Phase 2
Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease
A Phase 2 study of Stage III Colon Cancer, sponsored by NRG Oncology.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 1,912
- Enrollment target
- 20
- Study locations
NCT05174169: Recruiting Phase 2 study of Stage III Colon Cancer, sponsored by NRG Oncology.
NCT05174169 is a Phase 2 study of Stage III Colon Cancer that is actively recruiting participants, run by NRG Oncology. The registered enrollment target is 1,912 participants, above the 498-participant average among 6 other Stage III Colon Cancer trials with a reported enrollment target (284% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05174169, a Phase 2 study of Stage III Colon Cancer, is actively recruiting participants, sponsored by NRG Oncology.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 1,912 participants
- Enrollment target
- 20
- Study locations
Study Summary
This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.
Primary Outcome
TTPos is defined as time from randomization until ctDNA positive event: TTPos events are first ctDNA positive result after randomization for the immediate adjuvant chemo arm (Arm 1), 2nd ctDNA positive result after randomization for the delayed adjuvant chemo (Arm 2) and recurrence without a positive ctDNA result for both arms.
Conditions Studied
Interventions
- DEVICE Signatera test
- DRUG mFOLFOX6 3-6 month
- DRUG CAPOX 3 month
- DRUG mFOLFIRINOX
- DRUG mFOLFOX6 6 month
Study Locations (20)
California
- Kaiser Permanente-Anaheim - Anaheim
- Kaiser Permanente-Deer Valley Medical Center - Antioch
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- PCR Oncology - Arroyo Grande
- Sutter Auburn Faith Hospital - Auburn
- Sutter Cancer Centers Radiation Oncology Services-Auburn - Auburn
- AIS Cancer Center at San Joaquin Community Hospital - Bakersfield
Arizona
- Kingman Regional Medical Center - Kingman
- Cancer Center at Saint Joseph's - Phoenix
- Mayo Clinic Hospital in Arizona - Phoenix
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
- Thomas Hospital - Fairhope
- Mobile Infirmary Medical Center - Mobile
- University of South Alabama Mitchell Cancer Institute - Mobile
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
- University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,912 participants |
| Start Date | 2022-03-10 |
| Est. Completion | 2030-03-10 |
| Phase | Phase 2 |
What NCT05174169 shows while recruiting
NCT05174169 is an interventional study that assigns participants to a tested intervention. Its 1,912 participants enrollment target places it among the larger protocols in the corpus, above the 498-participant average among 6 other Stage III Colon Cancer trials with a reported enrollment target (284% higher).
The record links to 1 condition, with Stage III Colon Cancer appearing as the primary indexed condition, and to 5 interventions - of which Signatera test is the first listed.
NCT05174169 names 20 study sites across 4 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT05174169 about?
NCT05174169 is a clinical study titled "Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease". This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.
What is the current status of trial NCT05174169?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 1,912 participants. The study started on 2022-03-10. Estimated completion is 2030-03-10.
What conditions does trial NCT05174169 study?
This clinical trial studies the following conditions: Stage III Colon Cancer.
What interventions are being tested in trial NCT05174169?
The interventions under investigation include: Signatera test (DEVICE), mFOLFOX6 3-6 month (DRUG), CAPOX 3 month (DRUG), mFOLFIRINOX (DRUG), mFOLFOX6 6 month (DRUG).
Who is sponsoring clinical trial NCT05174169?
This trial is sponsored by NRG Oncology, which has 64 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05174169 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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