In This Section      
 

Search Results

Title:
A021502 Randomized Trial of Standard Chemotherapy Alone or Combined with Atezolizumab as Adjuvant Therapy for Patients with Stage III Colon Cancer and Deficient DNA Mismatch Repair
Protocol Number:
NCTNA021502
Phase:
Phase III
Physician:
Ana De jesus-acosta
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Sibley Memorial Hospital
Purpose:
The purpose of this study is to compare any good and bad effects of using the drug atezolizumab along with the usual chemotherapy compared to the usual chemotherapy alone. The addition of atezolizumab to the usual chemotherapy could prevent or reduce the chances of your cancer from returning, but it could also cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach.
Eligibility:
Patients who have colon cancer that was surgically removed but has spread to lymph nodes and is known as stage III colon cancer may be eligible for this study.
Treatment:
This study has two study groups.• Group 1 will get the usual chemotherapy treatment of FOLFOX plus the drug atezolizumab for 6 months, then patients will take atezolizumab alone for an additional 6 months.• Group 2 will get the usual chemotherapy which is FOLFOX for 6 months. How Treatments are Administered and How Often Treatments are Administered:• Oxaliplatin will be given as an IV infusion over a 2 hour window on the first day of every cycle*.• Leucovorin will be given as an IV infusion over a 2 hour window on the first day of every cycle*.• Fluorouracil will be given as an IV bolus on the first day of the cycle and as an IV infusion over a 46 hour window on the first through third days of every cycle*.• Atezolizumab (Group 1 only) will be given as an IV infusion over a 1 hour window for the first infusion, and then over a 30 minute window for all subsequent infusions on the first day of every cycle*.*One cycle is defined as 14 days.A computer will by chance assign you to treatment groups in the study. This is called randomization. This is done by chance because no one knows if one study group is better or worse than others. If you are in Group 1, you will receive chemotherapy and atezolizumab for 6 months, then you will take atezolizumab alone for an additional 6 months (25 cycles in total). If you are in Group 2, you will receive chemotherapy for 6 months (12 cycles in total). You will be able to start one cycle of chemotherapy before you are randomized if you choose while waiting for the test results described in the next section. If you choose this option and are then put in Group 1, you will receive chemotherapy and atezolizumab for 6 months, then you will take atezolizumab alone for an additional 6 months (24 cycles in total). For both groups, after treatment is complete, your doctor will continue to watch you for side effects and will follow your condition for up to 8 years since you started the study. If you do not complete treatment, your doctor will still watch you for side effects and follow your condition for up to 8 years since you started the study. The follow-up of your condition will occur at minimum every 6 months.If your cancer returns you will not be required to complete the recurring blood test or scans, but your doctor will continue to watch you for side effects and follow your condition for up to 8 years since you started the study.
Population:
Adult
Last Update
08/08/2020 05:02 AM