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Vitamin D3 With Chemotherapy and Bevacizumab in Treating Patients With Advanced or Metastatic Colorectal Cancer
NCT04094688 · View on ClinicalTrials.gov ↗
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04094688
The ClinicalTrials.gov registry entry for NCT04094688 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 455 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alliance for Clinical Trials in Oncology, which has 147 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04094688 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Alaska, Arkansas, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04094688?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 147 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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