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

Study on Combination Chemotherapy with Investigational Medication for Stage III Colon Cancer

Recruiting
18 years - 100 years
All
Phase N/A
1 Location

Brief description of study.

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.

Detailed description of study

The purpose of this study 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).
Participants will not be paid for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: DNA repair disorder,Lynch Syndrome,colon cancer
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria
In order to be eligible to take part in this trial, patients must meet the following criteria:

  • Histologically proven stage III colon adenocarcinoma (any T [Tx, T1, T2, T3, or T4], N1-2M0; includes N1C)
  • Presence of deficient (d) DNA mismatch repair (dMMR); MMR status must be assessed by immunohistochemistry (IHC) for MMR protein expression (MLH1, MSH2, MSH6, PMS2) where loss of one or more proteins indicates dMMR; dMMR may be determined either locally or by site-selected reference lab; Note: loss of MLH1 and PMS2 commonly occur together; formalin-fixed paraffin-embedded (FFPE) tumor tissue is required for subsequent retrospective central confirmation of dMMR status

For a full list of participation criteria, please visit clinicaltrials.gov.

Updated on 19 Feb 2024. Study ID: 1801705618 (A021502)

This study investigates the effectiveness of combination chemotherapy with an investigational medication compared to chemotherapy alone in patients with stage III colon cancer. The focus is on patients with a specific condition called deficient DNA mismatch repair (dMMR), which is when the body's natural ability to fix DNA mistakes is not working properly. The purpose of this study is to see if adding the investigational medication can improve the time patients remain free of cancer.

Participants will receive a combination of chemotherapy drugs, including oxaliplatin, leucovorin calcium, and fluorouracil, known as FOLFOX. Some participants will also receive an investigational medication along with FOLFOX, and then continue with the investigational medication alone. The study will compare the outcomes of these two groups to determine the effectiveness of the additional treatment.

  • Who can participate: Adults with stage III colon cancer and specific DNA mismatch repair deficiencies can participate. Tumors must be confirmed by laboratory tests, and participants must meet other health criteria.
  • Study details: Participants will receive chemotherapy drugs, and some will also receive an investigational medication. A placebo is not used.

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