Actively Recruiting
Vitamin D in Patients With Stage I-III Colon Cancer or Resectable Colon Cancer Liver Metastases
Led by Dana-Farber Cancer Institute · Updated on 2026-05-13
80
Participants Needed
1
Research Sites
676 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study seeks to learn more about the vitamin D receptor and its relationship to colon cancer. The Vitamin D receptor is found in colon cancer cells. When Vitamin D binds to the receptor in the cancer cells, it may stop cancer cells from growing abnormally and may cause cancer cell death. Vitamin D has been used in other research studies and information from those other research studies suggests that Vitamin D may help in the treatment of colon cancer. Participants will receive either high-dose vitamin D or standard-dose vitamin D. The study drug will be given 14-28 days prior to your surgery. The number of days will depend on when the surgery is scheduled.
CONDITIONS
Official Title
Vitamin D in Patients With Stage I-III Colon Cancer or Resectable Colon Cancer Liver Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have histologically confirmed adenocarcinoma of the colon, stage I, II, or III, with planned surgical resection
- OR have adenocarcinoma of the colon with resectable liver metastases planned for liver resection
- No prior radiation or systemic treatment for stage I-III colon cancer patients
- Prior treatment allowed for resectable liver metastases patients with last chemotherapy or radiation at least 4 weeks before surgery
- Last bevacizumab dose at least 6 weeks before liver surgery
- Age 18 years or older
- ECOG performance status 0 or 1
- Normal organ and marrow function as specified in the protocol
- Eligible if on full-dose anticoagulation with stable INR and no active bleeding risk
- Women of child-bearing potential must have a negative pregnancy test within 14 days before study entry
- Agree to use adequate contraception during the study
- Able and willing to provide informed consent
You will not qualify if you...
- Prior systemic therapy, radiotherapy, or investigational agent for stage I-III colon cancer surgery patients
- Chemotherapy or radiotherapy within 4 weeks (6 weeks for bevacizumab) before liver resection
- Using other anti-cancer therapies not specified in this study
- Unable to swallow pills
- History of malabsorption, uncontrolled vomiting or diarrhea affecting medication absorption
- Allergic reactions to vitamin D or similar compounds
- Regular use of supplemental vitamin D of 2000 IU/day or more in the past year
- Use of chronic oral corticosteroids or specific medications causing vitamin D depletion
- Regular use or unwillingness to stop thiazide diuretics
- Pre-existing high calcium levels
- Active hyperparathyroid disease or serious calcium metabolism disturbance in past 5 years
- History of symptomatic kidney stones within past year
- Uncontrolled illness or conditions increasing study risk or interfering with results
- Pregnant or nursing women or unwillingness to use contraception
- Prior or concurrent malignancy except certain treated cancers without active disease
- Known HIV, hepatitis B or C infection
AI-Screening
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Trial Site Locations
Total: 1 location
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
K
Kimmie Ng, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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