NCT04094688|Active Not RecruitingPhase 3ResultsDMCFDA Drug

Vitamin D3 With Chemotherapy and Bevacizumab in Treating Patients With Advanced or Metastatic Colorectal Cancer

SOLARIS

Randomized Double-Blind Phase III Trial of Vitamin D3 Supplementation in Patients With Previously Untreated Metastatic Colorectal Cancer (SOLARIS)

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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3 other identifiers

A021703NCI-2019-01034U10CA180821

Study Type

interventional

Target

455

Locations

2 countries

Sites

1031

Timeline

RegisteredSep 2019

StartedOct 2019

CompletionJul 2026

Brief 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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

455

participants targeted

Target at P50-P75 for phase_3

Timeline

2mo left

Started Oct 2019

Longer than P75 for phase_3

Geographic Reach

2 countries

1031 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.7 years study duration

Study Progress98%

Oct 2019Jul 2026

First Submitted

Initial submission to the registry

September 17, 2019

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed

1 month until next milestone

Study Start

First participant enrolled

October 29, 2019

Completed

4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2024

Completed

1.6 years until next milestone

Results Posted

Study results publicly available

March 3, 2026

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected

Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

4.7 years

First QC Date

September 17, 2019

Results QC Date

February 11, 2026

Last Update Submit

February 11, 2026

Conditions

Colorectal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

Progression-free Survival (PFS)
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 arm, and Kaplan-Meier curves will be produced. Brookmeyer-Crowley methodology will be used to construct the 95% CI for the median PFS for each treatment arm. All randomized patients regardless of any treatment received will be included in the analysis. Patients will be assigned to the treatment group they were randomized to regardless of actual treatment received.
4 years

Secondary Outcomes (7)

Objective Response
Up to 5 years
Overall Survival (OS)
From randomization to death due to any cause, assessed up to 5 years
Incidence of Adverse Events
Up to 5 years
Physical Activity (PA) and Progression-free Survival (PFS)
Up to 5 years
Incidence of Vitamin D3 Deficiency
At baseline
+2 more secondary outcomes

Study Arms (2)

Arm I (bevacizumab, chemotherapy, high-dose vitamin D3)

EXPERIMENTAL

Patients receive bevacizumab IV over 30-90 minutes on day 1 and oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV on days 1-3 or irinotecan hydrochloride IV on day 1, leucovorin calcium IV over 90 minutes on day 1, and fluorouracil IV on days 1-3. Patients also receive high-dose cholecalciferol PO QD on days 1-14. Cycles repeat every 14 days for 5 years in the absence of disease progression or unacceptable toxicity.

Drug: BevacizumabDrug: OxaliplatinDrug: Leucovorin CalciumDrug: FluorouracilDrug: Irinotecan HydrochlorideDrug: IrinotecanDietary Supplement: CholecalciferolOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Arm II (bevacizumab, chemotherapy, standard-dose vitamin D3)

ACTIVE COMPARATOR

Patients receive bevacizumab and chemotherapy as in Arm I. Patients also receive standard-dose cholecalciferol PO QD on days 1-14. Cycles repeat every 14 days for 5 years in the absence of disease progression or unacceptable toxicity.