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NCT05710406 · ClinicalTrials.gov registry record · Phase 2
Testing the Use of BRAF-Targeted Therapy After Surgery and Usual Chemotherapy for BRAF-Mutated Colon Cancer
A Phase 2 study of Colon Adenocarcinoma and Stage III Colon Cancer AJCC V8, sponsored by Alliance for Clinical Trials in Oncology.
- Active
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
- 20
- Study locations
NCT05710406: Active Phase 2 study of Colon Adenocarcinoma and Stage III Colon Cancer AJCC V8, sponsored by Alliance for Clinical Trials in Oncology.
NCT05710406 is a Phase 2 study of Colon Adenocarcinoma and Stage III Colon Cancer AJCC V8 that is active but no longer recruiting, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 1 participants, below the 726-participant average among 11 other Colon Adenocarcinoma trials with a reported enrollment target (100% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05710406, a Phase 2 study of Colon Adenocarcinoma and Stage III Colon Cancer AJCC V8, is active but no longer recruiting, sponsored by Alliance for Clinical Trials in Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II/III trial compares treatment with encorafenib and cetuximab to usual care (patient observation) for reducing the chance of cancer recurrence after standard surgery and chemotherapy in patients with BRAF-mutated stage IIB-III colon cancer. Encorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of tumor cells. This may help keep tumor cells from growing. Giving encorafenib and cetuximab after standard surgery and chemotherapy may be more effective at reducing the chance of cancer recurrence compared to the usual patient observation.
Primary Outcome
defined as the proportion of patients with undetectable ctDNA status at 6 months after randomization among patients with detectable ctDNA status at randomization. The ctDNA clearance rate at 6 months after randomization in experimental arm will be compared to control arm by Chi-squared test. The one-sided p-value will be reported. Due to small sample size, Cochran and Mantel-Haenszel test, stratified by stratification factors will be performed as sensitivity analysis.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- BIOLOGICAL Cetuximab
- DRUG Encorafenib
Study Locations (20)
Hawaii
- Hawaii Cancer Care Inc - Waterfront Plaza - Honolulu
- Queen's Cancer Cenrer - POB I - Honolulu
- Queen's Medical Center - Honolulu
- Straub Clinic and Hospital - Honolulu
- Queen's Cancer Center - Kuakini - Honolulu
- Hawaii Cancer Care - Westridge - ‘Aiea
- Pali Momi Medical Center - ‘Aiea
- The Queen's Medical Center - West Oahu - ‘Ewa Beach
Delaware
- Beebe South Coastal Health Campus - Millville
- Helen F Graham Cancer Center - Newark
- Medical Oncology Hematology Consultants PA - Newark
- Beebe Health Campus - Rehoboth Beach
Georgia
- Emory University Hospital Midtown - Atlanta
- Emory University Hospital/Winship Cancer Institute - Atlanta
- Emory Saint Joseph's Hospital - Atlanta
- Emory Johns Creek Hospital - Johns Creek
Idaho
- Saint Alphonsus Cancer Care Center-Boise - Boise
- Saint Luke's Cancer Institute - Boise - Boise
- Saint Alphonsus Cancer Care Center-Caldwell - Caldwell
- Kootenai Health - Coeur d'Alene - Coeur d'Alene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2023-08-16 |
| Est. Completion | 2034-06-01 |
| Phase | Phase 2 |
What the registry record for NCT05710406 still lists
NCT05710406 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 726-participant average among 11 other Colon Adenocarcinoma trials with a reported enrollment target (100% lower).
The record links to 5 conditions, with Colon Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05710406 names 20 study sites across 4 states, led by Hawaii, Delaware, Georgia.
Frequently Asked Questions
What is clinical trial NCT05710406 about?
NCT05710406 is a clinical study titled "Testing the Use of BRAF-Targeted Therapy After Surgery and Usual Chemotherapy for BRAF-Mutated Colon Cancer". This phase II/III trial compares treatment with encorafenib and cetuximab to usual care (patient observation) for reducing the chance of cancer recurrence after standard surgery and chemotherapy in patients with BRAF-mutated stage IIB-III colon cancer. Encorafenib may stop the growth of tumor cells ...
What is the current status of trial NCT05710406?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2023-08-16. Estimated completion is 2034-06-01.
What conditions does trial NCT05710406 study?
This clinical trial studies the following conditions: Colon Adenocarcinoma, Stage III Colon Cancer AJCC V8, Stage IIB Colon Cancer AJCC v8, Stage IIC Colon Cancer AJCC v8, Microsatellite Stable Colon Carcinoma.
What interventions are being tested in trial NCT05710406?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Cetuximab (BIOLOGICAL), Encorafenib (DRUG).
Who is sponsoring clinical trial NCT05710406?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05710406 being conducted?
This trial has 20 study locations across Delaware, Georgia, Hawaii, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Colon Adenocarcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05710406's enrollment target sits among peer trials
1 12th of 11 the lowest of 11 other Colon Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colon Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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