Study on Chemotherapy With or Without Atezolizumab for Stage III Colon Cancer With DNA Repair Deficiency
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT02912559
This clinical trial is exploring whether adding the immunotherapy drug atezolizumab to standard chemotherapy can improve treatment outcomes for patients with stage III colon cancer that has a specific DNA repair deficiency.
Patient Parameters
| Parameter | Options |
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Program Overview
This study is investigating if combining the immunotherapy drug atezolizumab with standard chemotherapy drugs (oxaliplatin, leucovorin, and fluorouracil) can better treat stage III colon cancer with a DNA repair deficiency compared to chemotherapy alone. The chemotherapy drugs work by stopping cancer cells from growing and spreading, while atezolizumab helps the immune system attack the cancer. The trial aims to see if this combination can improve survival rates and quality of life for patients.
Description
The main goal of this study is to find out if adding atezolizumab to the chemotherapy regimen FOLFOX can improve the time patients remain free of cancer compared to using FOLFOX alone. Researchers will also look at overall survival rates, side effects, and quality of life impacts.
Patients will be randomly assigned to one of two groups:
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Group 1: Will receive the standard chemotherapy drugs (oxaliplatin, leucovorin, and fluorouracil) along with atezolizumab. This treatment will be given every two weeks for up to 25 cycles, unless the cancer progresses or side effects become too severe. Patients will have regular scans and blood tests to monitor their progress.
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Group 2: Will receive the standard chemotherapy drugs without atezolizumab. This treatment will also be given every two weeks for up to 12 cycles, with regular scans and blood tests.
After completing the treatment, patients will be monitored for cancer recurrence every six months for two years, and then annually for three more years. Survival will be tracked every six months for up to eight years.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with stage III colon cancer that has a specific DNA repair deficiency.
- Cancer must have been completely removed by surgery.
- No previous treatment for this colon cancer, except for one cycle of a specific chemotherapy regimen.
- Age 12 years or older.
- Good overall health, with specific performance status scores based on age.
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
- Adequate blood cell counts and organ function as determined by specific tests.
- No active autoimmune diseases or infections like hepatitis B or C.
- HIV-positive patients can participate if they meet certain health criteria.
- No allergies to the study drugs or their components.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Fairbanks Memorial Hospital | 99701 | Fairbanks | Alaska |
| Cancer Center at Saint Joseph's | 85004 | Phoenix | Arizona |
| Mayo Clinic Hospital in Arizona | 85054 | Phoenix | Arizona |
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