At a glance
ClinicalIndex Comparison Record- ✓Histologically proven stage III colon adenocarcinoma (any T, N1-2M0) with tumors originating in the colon
- ✓Deficient (d) DNA mismatch repair (dMMR) confirmed by immunohistochemistry (IHC) showing loss of one or more MMR proteins (MLH1, MSH2, MSH6, PMS2)
- ✓Tumors completely resected with R0 resection; en bloc resection required for tumors adherent to adjacent structures; near or positive radial margins acceptable, but proximal or distal margin positivity not permitted
- ✓Entire tumor located in colon (rectal involvement excluded)
- ✕MSI-H status by PCR unless confirmed dMMR by IHC
- ✕Rectal tumor involvement or rectal primary
- ✕Active autoimmune disease including colitis, inflammatory bowel disease, rheumatoid arthritis, adrenal insufficiency
- ✕Active hepatitis B or C
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Atezolizumab, Biospecimen Collection, and 6 other interventions for Colon Adenocarcinoma and 3 related conditions. Active but no longer recruiting, targeting 712 participants across 1,050 sites in 3 countries.
Signals
Detailed Summary
This phase III trial studies combination chemotherapy and atezolizumab to see how well it works compared with combination chemotherapy alone in treating patients with stage III colon cancer and deficient deoxyribonucleic acid (DNA) mismatch repair (dMMR). Drugs used in combination chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy with atezolizumab may work better than combination chemotherapy alone in treating patients with dMMR colon cancer.
Study Details
Timeline
Arms & Interventions
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive atezolizumab IV over 30-60 minutes on day 1 of each cycle, beginning in cycle 1 or 2. Treatment repeats every 14 days for up to 25 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial.
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial.
Interventions
Given IV
Undergo blood sample collection
Undergo CT
Given IV
Given IV
Undergo MRI
Given IV
Ancillary studies