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Vitamin D3 + Chemotherapy + Bevacizumab for Colorectal Cancer (SOLARIS Trial)
SOLARIS Trial Summary
This trial is testing whether giving vitamin D3 with standard chemo and bevacizumab helps treat colorectal cancer that has spread.
SOLARIS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSOLARIS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2010 Phase 4 trial • 109 Patients • NCT01265615SOLARIS Trial Design
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Who is running the clinical trial?
Media Library
- I have completed my rectal cancer radiation treatment more than 4 weeks ago.My cancer does not have a known genetic mismatch repair issue.I do not have plans for surgery to remove cancer that has spread.I do not have severe heart failure.I don't have any conditions that badly affect my stomach or intestines.You have never had an allergic reaction to drugs that are similar to the ones being used in the study.I had major surgery over 4 weeks ago or minor surgery over a week ago and have recovered.I am fully active or can carry out light work.I haven't had serious bleeding issues in the last 6 months.I had chemotherapy or chemoradiation for colorectal cancer over a year ago.I haven't taken more than 2000 IU of vitamin D daily for a year before signing up.I am not pregnant or breastfeeding, and if capable of becoming pregnant, I have a recent negative pregnancy test.I do not have any serious wounds, ulcers, or unhealed bone fractures.My kidney function, measured by creatinine levels or clearance, is within the normal range.I have no active cancer except for non-melanoma skin cancer or cervical carcinoma in situ, and have been free of any other cancer for 3 years.I haven't had a stroke, heart attack, or severe angina in the last 6 months.I have not had any drug treatments for cancer that has spread.My cancer does not have a known mismatch repair deficiency or high microsatellite instability.I haven't had serious artery problems in the last 6 months.I haven't had any treatment for cancer that has spread.I completed my last radiation therapy for rectal cancer more than 4 weeks ago.I haven't had a GI perforation in the last year, except if it was due to colorectal cancer that's been removed.I haven't taken more than 2000 IU of vitamin D daily for a year before signing up.I had chemotherapy or chemoradiation for colorectal cancer over a year ago.My colorectal cancer has spread, and surgery to remove the spread is not planned.I had major surgery over 4 weeks ago or minor surgery over a week ago and have recovered.
- Group 1: Arm I (bevacizumab, chemotherapy, high-dose vitamin D3)
- Group 2: Arm II (bevacizumab, chemotherapy, standard-dose vitamin D3)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any current vacancies for this type of medical research?
"The research indicates that this study is looking for patients. The original posting date was September 30th, 2019 and the latest update was on September 25th, 2022."
Has the US Food and Drug Administration cleared Cholecalciferol for public consumption?
"There is some evidence to support the efficacy of Cholecalciferol, as this is a Phase 3 trial. Furthermore, there is data from multiple rounds supporting its safety; thus, we have given it a score of 3."
Which medical condition is Cholecalciferol mostly prescribed for?
"Cholecalciferol is used to target a variety of cancerous growths, such as those found in the rectum, colon, and sarcoma. Additionally, this medication can be deployed against locally advanced stages of nonsquamous non-small cell lung cancer."
Are there other investigations that have involved this vitamin D3 supplement?
"Cholecalciferol is being trialed in 969 clinical studies. Of these, 280 are Phase 3 trials. The vast majority of these medical trials are based in Guangzhou, Guangdong; however, there are a total of 42263 locations running Cholecalciferol trials."
At how many hospitals is this research being conducted?
"There are 100 sites currently enrolling patients in this study. The locations of these clinics are listed on the website, and it is recommended that you select the one nearest to you to reduce travel time if you decide to participate."
How many people are signing up to participate in this experiment?
"That is correct. As of September 25th, 2022, this clinical trial was still recruiting patients, 400 in total from 100 different locations around the world."
Who else is applying?
What state do they live in?
How old are they?
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What portion of applicants met pre-screening criteria?
Why did patients apply to this trial?
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