All studies
Active not recruitingPHASE3INTERVENTIONAL

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

Status
Active not recruiting
Phase
PHASE3
Sponsor
National Cancer Institute (NCI)
Enrolment target
2,431
Start
06 Sep 2005
Estimated completion
11 Apr 2027

Results

Results from this study

Posted July 2025

Results have been published for this study.

Primary outcome
Disease-free Survival Rate at 5 Years
Disease-free survival (DFS) is defined as the time from randomization to the earlier of disease recurrence, new invasive primary cancer, or death from any cause. The Kaplan-Meier estimates were used to characterize the 5-year DFS rates.
Full results on the registry

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.

  1. Have you had surgery for stage 2 colon cancer?
  2. Is your cancer located far enough away from your anus (at least 12 cm)?
  3. Do you have a tumour sample available from your surgery?
  4. Do you have any other colon tumours or inflammatory bowel disease?
  5. Are you generally healthy enough for chemotherapy treatments?
Answer every question to see your result.

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

Taking part in this study could offer several potential benefits. While there is no guarantee, you might receive a treatment that is more effective at preventing your colon cancer from returning. You would also receive very close medical monitoring throughout the study, which could lead to any issues being identified early. However, all medical treatments carry risks. These chemotherapy drugs and bevacizumab can have side effects, which can range from mild to serious, and may include feeling sick, tiredness, hair loss, nerve problems, or issues with bleeding or healing. The research team will explain all known side effects in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (929)

  • Northeast Alabama Regional Medical Center
    Verified postcode
    Anniston, United States
  • University of Alabama at Birmingham Cancer Center
    Verified postcode
    Birmingham, United States
  • Clearview Cancer Institute
    Verified postcode
    Huntsville, United States
  • Mobile Infirmary Medical Center
    Verified postcode
    Mobile, United States
  • Providence Hospital
    Verified postcode
    Mobile, United States
  • Providence Alaska Medical Center
    Verified postcode
    Anchorage, United States
  • Mayo Clinic in Arizona
    Verified postcode
    Scottsdale, United States
  • Banner University Medical Center - Tucson
    Verified postcode
    Tucson, United States
  • Mercy Hospital Fort Smith
    Verified postcode
    Fort Smith, United States
  • NEA Baptist Memorial Hospital
    Verified postcode
    Jonesboro, United States
  • Alta Bates Summit Medical Center-Herrick Campus
    Verified postcode
    Berkeley, United States
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
    Verified postcode
    Burbank, 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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