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NCT04094688 · ClinicalTrials.gov registry record · Phase 3
Vitamin D3 With Chemotherapy and Bevacizumab in Treating Patients With Advanced or Metastatic Colorectal Cancer
A Phase 3 study of Colorectal Adenocarcinoma, sponsored by Alliance for Clinical Trials in Oncology.
- Active
- Registry status
- Phase 3
- Development phase
- 455
- Enrollment target
- 20
- Study locations
NCT04094688: Active Phase 3 study of Colorectal Adenocarcinoma, sponsored by Alliance for Clinical Trials in Oncology.
NCT04094688 is a Phase 3 study of Colorectal Adenocarcinoma that is active but no longer recruiting, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 455 participants, above the 295-participant average among 19 other Colorectal Adenocarcinoma trials with a reported enrollment target (54% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04094688, a Phase 3 study of Colorectal Adenocarcinoma, is active but no longer recruiting, sponsored by Alliance for Clinical Trials in Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 455 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial studies how well vitamin D3 given with standard chemotherapy and bevacizumab works in treating patients with colorectal cancer that has spread to other parts of the body. Vitamin D3 helps the body use calcium and phosphorus to make strong bones and teeth. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, oxaliplatin, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as bevacizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving vitamin D3 with chemotherapy and bevacizumab may work better in shrinking or stabilizing colorectal cancer. It is not yet known whether giving high-dose vitamin D3 in addition to chemotherapy and bevacizumab would extend patients' time without disease compared to the usual approach (chemotherapy and bevacizumab).
Primary Outcome
Per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. Progression-free survival (PFS) will be compared between treatment arms using the un-stratified log-rank test at one-sided level of 0.05 and the p-value will be used for decision making. The hazard ratio (HR) for PFS will be estimated using a Cox proportional hazards model and the 95% confidence interval (CI) for the HR will be provided. Kaplan-Meier methodology will be used to estimate the median PFS for each treatment a
Conditions Studied
Interventions
- DRUG Bevacizumab
- DRUG Fluorouracil
- DRUG Oxaliplatin
- DRUG Irinotecan Hydrochloride
- DRUG Leucovorin Calcium
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
- John L McClellan Memorial Veterans Hospital - Little Rock
- University of Arkansas for Medical Sciences - Little Rock
Arizona
- CTCA at Western Regional Medical Center - Goodyear
- Kingman Regional Medical Center - Kingman
- Cancer Center at Saint Joseph's - Phoenix
California
- Kaiser Permanente-Deer Valley Medical Center - Antioch
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- PCR Oncology - Arroyo Grande
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 455 participants |
| Start Date | 2019-10-29 |
| Est. Completion | 2026-07-01 |
| Phase | Phase 3 |
What the registry record for NCT04094688 still lists
NCT04094688 is an interventional study that assigns participants to a tested intervention. The registered 455 participants enrollment target is mid-sized for trials with a published cap, above the 295-participant average among 19 other Colorectal Adenocarcinoma trials with a reported enrollment target (54% higher).
The record links to 1 condition, with Colorectal Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Bevacizumab is the first listed.
NCT04094688 names 20 study sites across 5 states, led by Alaska, Arkansas, Arizona.
Frequently Asked Questions
What is clinical trial NCT04094688 about?
NCT04094688 is a clinical study titled "Vitamin D3 With Chemotherapy and Bevacizumab in Treating Patients With Advanced or Metastatic Colorectal Cancer". This phase III trial studies how well vitamin D3 given with standard chemotherapy and bevacizumab works in treating patients with colorectal cancer that has spread to other parts of the body. Vitamin D3 helps the body use calcium and phosphorus to make strong bones and teeth. Drugs used in chemother...
What is the current status of trial NCT04094688?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 455 participants. The study started on 2019-10-29. Estimated completion is 2026-07-01.
What conditions does trial NCT04094688 study?
This clinical trial studies the following conditions: Colorectal Adenocarcinoma.
What interventions are being tested in trial NCT04094688?
The interventions under investigation include: Bevacizumab (DRUG), Fluorouracil (DRUG), Oxaliplatin (DRUG), Irinotecan Hydrochloride (DRUG), Leucovorin Calcium (DRUG).
Who is sponsoring clinical trial NCT04094688?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04094688 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Colorectal 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 NCT04094688's enrollment target sits among peer trials
455 5th of 19 higher than 15 of 19 other Colorectal Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal 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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