Study Will Investigate If Giving Chemo Before and After Surgery Can Boost Gallbladder Cancer Outcomes

Researchers on an ongoing clinical trial are hoping to determine if administering pre-surgical and post-surgical chemotherapy can improve outcomes in patients with stage 2 or 3 gallbladder cancer — a disease that has less than a 20% five-year survival rate, according to the American Cancer Society.

The EA2197 trial, which is currently enrolling patients in various cancer centers across the United States, will compare overall survival (time from treatment until death of any cause) and progression-free survival (time from treatment until disease worsens) between two groups of patients with gallbladder carcinoma: one group will undergo upfront surgical removal of the lymph nodes and/or liver and then treatment with cisplatin and gemcitabine, while the other will receive the chemotherapy agents both before and after surgery.

“Chemotherapy drugs, such as gemcitabine and cisplatin, 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. Giving chemotherapy before surgery may make the tumor smaller; therefore, may reduce the extent of surgery,” the researchers wrote in the study description. “Additionally, it may make it easier for the surgeon to distinguish between normal and cancerous tissue.”

The researchers also plan on looking at the incidence of residual disease (small amounts of disease leftover after surgery) and rate of patients who were able to undergo surgery. Of note, if the disease spreads to other parts of the body before resection, the patient will not be eligible for surgery.

To be eligible for the trial, patients must have gallbladder cancer that has spread to the perimuscular connective tissue (stage T2 disease) or that has spread through the gallbladder wall (stage T3 disease). They also must have undergone surgical removal of the gallbladder — a process known as cholecystectomy — within 12 weeks before enrolling.

“Giving chemotherapy after surgery may kill any remaining tumor cells,” the researchers wrote. “This study will determine whether giving chemotherapy before surgery increases the length of time before the cancer may return and whether it will increase a patient's life span compared to the usual approach.”

The researchers predict that the study will be completed on Sept. 30, 2023.

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