Clinical trial · Interventional
Study of Vitamin D in Untreated Metastatic Colorectal Cancer
Randomized, Double-Blind, Phase II Trial of Vitamin D Supplementation in Patients With Previously Untreated Metastatic Colorectal Cancer
NCT01516216CI-TRIAL-00058032completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective, randomized, double-blind phase II trial to evaluate the efficacy and safety of two doses of vitamin D supplementation in combination with standard chemotherapy in participants with previously-untreated metastatic colorectal adenocarcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFOX + bevacizumab | Drug | — | UNRESOLVED |
| Vitamin D | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy + Standard Dose Vitamin D
- description
- FOLFOX-bevacizumab: intravenously on Day 1 (+/- 7 days) of every two-week cycle per institutional standards + 400 IU vitamin D3 orally once daily Participants were treated until disease progression, unacceptable toxicity or withdrawal for other reasons.
- interventionNames
- Drug: FOLFOX + bevacizumab
- Dietary Supplement: Vitamin D
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy + Higher Dose
- description
- FOLFOX-bevacizumab: intravenously on Day 1 (+/- 7 days) of every two-week cycle per institutional standards + 8000 IU daily x 2 weeks as loading dose, followed by 4000 IU daily as maintenance dose. Participants were treated until disease progression, unacceptable toxicity or withdrawal for other reasons.
- interventionNames
- Drug: FOLFOX + bevacizumab
- Dietary Supplement: Vitamin D
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the colon or rectum that is metastatic or locally advanced (unresectable) * Measurable disease * KRAS wild-type and KRAS mutant patients are eligible * No prior systemic treatment for advanced or metastatic colorectal cancer is allowed * No prior radiotherapy to more than 25% of bone marrow * No surgery or major biopsy within 4 weeks of randomization * Paraffin-embedded and/or snap-frozen tumor tissue samples must be available Exclusion Criteria: * Not pregnant or breastfeeding * No prior chemotherapy, systemic therapy or investigational agent * No concurrent use of other anti-cancer therapy * No known brain metastases * No history of other malignancies except adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, curatively treated lobular or ductal carcinoma in situ of the breast or other cancer curatively treated with no evidence of disease for more than 3 years prior to randomization * No regular use of vitamin D supplements greater than 2000 IU per day in the past year * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to 5-FU, capecitabine, oxaliplatin, leucovorin, bevacizumab and/or vitamin D3 * No significant history of bleeding events, pre-existing bleeding diathesis, coagulopathy or gastrointestinal perforation * No arterial thrombotic events within 6 months of randomization * No serious non-healing wound, ulcer or bone fracture * No history of uncontrolled hypertension * No clinically significant peripheral neuropathy * No predisposing colonic or small bowel disorders in which the symptoms are uncontrolled * No uncontrolled seizure disorder or active neurological disease * No pre-existing hypercalcemia * No known active hyperparathyroid disease * No regular use of thiazide diuretics * No malabsorption, uncontrolled vomiting or diarrhea * No known co-morbid disease that would increase the risk of toxicity * No use of chronic oral corticosteroid therapy or any other therapy that can cause vitamin D depletion * No clinically significant cardiovascular disease * No uncontrolled intercurrent illness * No history of any medical or psychiatric condition or addictive disorder or laboratory abnormality that may increase the risks associated with study participation
References
Publications (1)
- BACKGROUNDNg K, Nimeiri HS, McCleary NJ, Abrams TA, Yurgelun MB, Cleary JM, Rubinson DA, Schrag D, Miksad R, Bullock AJ, Allen J, Zuckerman D, Chan E, Chan JA, Wolpin BM, Constantine M, Weckstein DJ, Faggen MA, Thomas CA, Kournioti C, Yuan C, Ganser C, Wilkinson B, Mackintosh C, Zheng H, Hollis BW, Meyerhardt JA, Fuchs CS. Effect of High-Dose vs Standard-Dose Vitamin D3 Supplementation on Progression-Free Survival Among Patients With Advanced or Metastatic Colorectal Cancer: The SUNSHINE Randomized Clinical Trial. JAMA. 2019 Apr 9;321(14):1370-1379. doi: 10.1001/jama.2019.2402. PMID 30964527