• Active since September 12, 2017
• Targeted enrollment of 700
• Primary study endpoint is disease-free survival (DFS)


TREATING PATIENTS WITH STAGE III COLON CANCER AND DEFICIENT DNA MISMATCH REPAIR

Alliance A021502 (Randomized trial of FOLFOX alone or combined with atezolizumab as adjuvant therapy for patients with stage III colon cancer and deficient DNA mismatch repair or microsatellite instability (ATOMIC)) is being led by Frank Sinicrope, MD, of the Mayo Clinic in Rochester, MN.

ATOMIC is an active phase III trial that 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. Drugs used in combination chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells. 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 colon cancer.

KEY OBJECTIVES
The primary objective of the ATOMIC trial is to determine whether atezolizumab combined with oxaliplatin, leucovorin calcium, and fluorouracil (FOLFOX) and its continuation as monotherapy can significantly improve disease-free survival (DFS) compared to FOLFOX alone in patients with stage III colon cancers and deficient DNA mismatch repair (dMMR).

Secondary objectives:
• To determine whether atezolizumab combined with FOLFOX and its continuation as monotherapy can significantly improve overall survival compared to FOLFOX alone in patients with stage III colon cancers and dMMR.
• To assess the adverse events (AE) profile and safety of each treatment arm, using the Common Terminology Criteria for Adverse Events (CTCAE) and patient-related outcomes (PRO)-CTCAE.

Quality of life objective:
• To determine the impact of the addition of atezolizumab to FOLFOX on patient-reported neuropathy, health-related quality of life (QOL), and functional domains of health-related QOL.

ELIGIBILITY CRITERIA
• Histologically proven stage III colon adenocarcinoma
• Presence of deficient MMR(dMMR) via IHC
• Completely resected tumors
• Entire tumor in colon
• No evidence of residual involved lymph node disease or metastatic disease
• Patients known to have Lynch Syndrome are eligible
• No other planned concurrent investigational agents or other tumor-directed therapy
• No active autoimmune disease, including colitis, panhypopituitarism, adrenal insufficiency
• No known active hepatitis B or C infection
• No active pulmonary disease with hypoxia
• No grade ≥ 2 peripheral motor or sensory neuropathy
• Non-pregnant, non-nursing
• Age ≥ 12 years

SCHEMA

 


 

 

 







To learn more about the trial and trial locations, visit:
ClinicalTrials.gov: NCT02912559

Information and assistance from the National Cancer Institute (NCI)
Trained information specialists at the NCI are available to answer cancer-related questions from patients, family members or friends, health care providers, and researchers. Visit the NCI’s Cancer Information Service [http://www.cancer.gov/global/contact] webpage for contact instructions, including telephone, live chat, e-mail, and mail.