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Chemotherapy +/− Bevacizumab for Stage II Colon Cancer
Study Summary
This trial is testing a combination of drugs to treat patients who have had surgery for stage II colon cancer, to see if it is more effective than a standard combination of drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have had a condition where my lymphocytes multiply unusually.I haven't had any cancer except for skin cancer in the last 5 years.I have a tumor sample available for specific genetic testing.I have not had a heart attack or unstable angina in the last year.I have symptoms related to poor blood flow in my limbs.I do not have more than one tumor at the same time.I do not have a tumor in my appendix.My lab tests for Step 2 were done within the last 2 weeks.I have not had a stroke or mini-stroke in the last year.I do not have symptoms from peripheral vascular disease.My cancer has spread to the mesentery but without clear lymph node involvement.I have had radiation therapy to my pelvic area before.I haven't had significant bleeding unrelated to my colon cancer in the last 6 months.I have a serious or non-healing wound, skin ulcer, or bone fracture.I am currently experiencing significant nerve pain or tingling.I have not had any major surgeries or procedures recently.My tumor is located at least 12 cm from the anal opening, as confirmed by a doctor.My colon cancer is confirmed to be Stage II adenocarcinoma.I have hereditary non-polyposis colorectal cancer.I have never had inflammatory bowel disease.I have never had cancer spread to distant parts of my abdomen.My surgery removed all visible cancer without leaving any behind.I haven't started any treatment for my cancer.I have not had a complete blockage or tear in my intestines.I do not have another type of cancer besides the one being treated.I can take care of myself and am up and about more than half of my waking hours.I will start treatment between 28 and 60 days after my surgery.I do not have any health conditions that would prevent me from taking the study drugs.I have a history of high blood pressure that doesn't meet certain criteria.
- Group 1: Arm C (observation)
- Group 2: Arm A (oxaliplatin, leucovorin calcium, fluorouracil)
- Group 3: Arm B (combination chemotherapy, bevacizumab)
- 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
Could you please tell me how many different medical facilities are participating in this clinical trial?
"100 patients are being recruited from medical centres such as Cottonwood Hospital Medical Center in Murray, Hutchinson Regional Medical Center in Hutchinson, and Meeker County Memorial Hospital in Litchfield, as well as 100 other locations."
For what purpose is Fluorouracil most commonly prescribed?
"Fluorouracil is an effective treatment for various medical conditions including, but not limited to, joints, rectal carcinoma, and locally advanced nonsquamous non-small cell lung cancer."
How does Fluorouracil's efficacy compare to other cancer treatments?
"At this time, 884 live studies are investigating Fluorouracil with 272 of those in the third stage of clinical trials. Many of the Guangzhou, Guangdong trials are based in Guangzhou, but there are a total of 39664 locations running studies for Fluorouracil."
Are there serious side effects associated with Fluorouracil?
"There is some evidence to support Fluorouracil's efficacy, as it is a Phase 3 trial. Additionally, there is safety data from multiple rounds of testing, warranting a score of 3."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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