Oxaliplatin, Leucovorin, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer
This study is for people who have had surgery for stage 2 colon cancer. It's looking at whether adding a drug called bevacizumab to standard chemotherapy (oxaliplatin, leucovorin, and fluorouracil) helps prevent the cancer from coming back. Chemotherapy drugs work by stopping cancer cells from growing and spreading. Bevacizumab is a different type of drug that may also interfere with cancer growth. The study wants to find out if combining these treatments is more effective than chemotherapy alone. Some patients will receive the combination, others just chemotherapy, and some with lower-risk cancer will be closely watched without extra treatment. The main goal is to see if adding bevacizumab improves the time people live without their cancer returning.
At a glance
Results
Results from this study
Posted July 2025Results have been published for this study.
What is this study about?
This study is designed for adults who have had surgery for stage 2 colon cancer. This means the cancer has grown into the wall of the bowel, but it hasn't spread to other parts of the body. Once the surgery is done, doctors often consider further treatments to reduce the chance of the cancer coming back. This study is testing if adding a specific drug called bevacizumab to a common chemotherapy combination (oxaliplatin, leucovorin, and fluorouracil) is more effective than the chemotherapy alone.
Chemotherapy drugs work by attacking fast-growing cells, which include cancer cells. Oxaliplatin, leucovorin, and fluorouracil are medicines that have been used to treat colon cancer for some time. Bevacizumab is a newer type of drug. It's called a 'monoclonal antibody' and works by trying to stop cancer cells from developing new blood vessels, which they need to grow and spread. The researchers want to know if this combination of treatments will help people live longer without their cancer returning.
The study also aims to understand more about the side effects of these treatments and how certain features of a person's cancer might affect their recovery. By comparing different treatment approaches, the study hopes to find the best ways to treat stage 2 colon cancer after surgery.
Key takeaways
- This study is for adults with stage 2 colon cancer after surgery.
- It compares standard chemotherapy to chemotherapy plus bevacizumab.
- The goal is to improve the chance of staying cancer-free.
- Participation involves treatment for about 6-12 months and long-term follow-up.
- Side effects are possible with all treatments, and will be discussed fully.
- You have the right to leave the study at any time.
Who may be eligible?
To join this study, you must have had surgery for stage 2 colon cancer. This means the cancer was found in your colon but had not spread to other organs. Your original tumour must be at least 12cm from your anus, or confirmed by surgical examination. Also, a sample of your tumour (often taken during surgery) must be available for testing to help doctors understand more about your cancer.
There are certain conditions that would mean you can't join this study. For example, if you have other tumours in your bowel, or if you have a history of inflammatory bowel disease, you wouldn't be able to take part. However, if you have a condition called hereditary non-polyposis colorectal cancer (HNPCC), you may still be eligible.
Based on your tumour test results, you'll be put into a “high-risk” or “low-risk” group. If you're in the high-risk group, you’ll be randomly assigned to receive either the standard chemotherapy or the chemotherapy plus bevacizumab. If you're in the low-risk group, you'll be closely observed without receiving additional drug treatment.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Have you had surgery for stage 2 colon cancer?
- Is your cancer located far enough away from your anus (at least 12 cm)?
- Do you have a tumour sample available from your surgery?
- Do you have any other colon tumours or inflammatory bowel disease?
- Are you generally healthy enough for chemotherapy treatments?
What does participation involve?
If you join this study, your participation will involve several steps. Firstly, after your surgery, a sample of your tumour will be tested to help decide if your cancer is considered high-risk or low-risk. If you're in the high-risk group, you'll be randomly assigned to one of two treatment groups: one group receives standard chemotherapy (oxaliplatin, leucovorin, and fluorouracil), and the other group receives the same chemotherapy plus bevacizumab. Each treatment cycle is given every two weeks for a total of 12 cycles (about 6 months). If you receive bevacizumab, you'll continue to receive it alone for another 12 cycles after the chemotherapy finishes.
The chemotherapy drugs are given as an injection into a vein (intravenously), taking a few hours. Bevacizumab is also given as an injection into a vein over approximately 30-90 minutes. Throughout your treatment, doctors will closely monitor you for any side effects. If you're in the low-risk group, you won't receive extra drug treatment but will be closely observed.
After your treatment or observation period ends, you'll have regular follow-up appointments. These will be every three months for the first two years, then every six months for the next three years, and finally once a year for a further 10 years. This long follow-up helps researchers track your health and how well the treatments worked over time.
Potential risks and benefits
Locations (929)
- Northeast Alabama Regional Medical CenterVerified postcodeAnniston, United States
- University of Alabama at Birmingham Cancer CenterVerified postcodeBirmingham, United States
- Clearview Cancer InstituteVerified postcodeHuntsville, United States
- Mobile Infirmary Medical CenterVerified postcodeMobile, United States
- Providence HospitalVerified postcodeMobile, United States
- Providence Alaska Medical CenterVerified postcodeAnchorage, United States
- Mayo Clinic in ArizonaVerified postcodeScottsdale, United States
- Banner University Medical Center - TucsonVerified postcodeTucson, United States
- Mercy Hospital Fort SmithVerified postcodeFort Smith, United States
- NEA Baptist Memorial HospitalVerified postcodeJonesboro, United States
- Alta Bates Summit Medical Center-Herrick CampusVerified postcodeBerkeley, United States
- Providence Saint Joseph Medical Center/Disney Family Cancer CenterVerified postcodeBurbank, United States
Common questions
What is the main purpose of this study?
The main purpose is to see if adding the drug bevacizumab to standard chemotherapy helps people with stage 2 colon cancer stay cancer-free longer after surgery.
Who can join this study?
Adults who have had surgery for stage 2 colon cancer and meet specific health and tumour requirements may be eligible.
What treatments are being compared?
The study compares standard chemotherapy (oxaliplatin, leucovorin, fluorouracil) with the same chemotherapy plus bevacizumab. Some low-risk patients will only be observed.
How long does the treatment last?
Chemotherapy treatments typically last about 6 months (12 cycles). If you receive bevacizumab, you'll continue it alone for another 6 months.
Will I know which treatment I'm getting?
If you're in the high-risk group, you'll be randomly assigned to one of the two treatment groups, so you won't choose which one. However, your doctors will tell you which treatment you are receiving once assigned.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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