Ongoing Trial: The OPT-IN clinical trial is studying a new treatment approach for patients with gallbladder cancer

The gallbladder is a small organ under the liver. Cancer of the gallbladder is a rare disease that is most often discovered incidentally. This means doctors only find the cancer because a patient has undergone non-urgent surgery to remove the gallbladder for another reason. In such cases, patients typically do not have any symptoms of cancer.

The usual treatment for these patients is a second surgery to remove any leftover cancer cells from the nearby liver tissue and lymph nodes. Then, patients have 6 months of chemotherapy. However, as many as four out of every 10 patients (40%) may see the cancer return within one year after treatment. These patients need better options. Recent research suggests that patients may have better results if chemotherapy is given both before and after surgery. When given before surgery, chemotherapy can help kill any cancer cells that may be hiding and make surgery less invasive.

The OPT-IN research study (EA2197) is testing this idea and asking the following question: Will giving chemotherapy before and after surgery in patients with incidental gallbladder cancer lead to better results than only giving chemotherapy after surgery?

About 186 patients will take part in the study. Patients will be randomly assigned by a computer to one of two groups. About one-third of participants will be in Group One and will receive the usual treatment: surgery followed by 6 months of chemotherapy with gemcitabine and cisplatin. About two-thirds of participants will be in Group Two and will receive 3 months of chemotherapy before surgery (also with gemcitabine and cisplatin) followed by surgery, if their cancer is stable. After surgery, they will have another 3 months of treatment with the same chemotherapy drugs. All patients will undergo follow-up with imaging for at least 3 years after treatment ends.

Importantly, patients can receive their chemotherapy treatments in a community hospital close to home and thus will not have to travel long distances to the primary cancer center or hospital that is conducting the study. Only their surgery and follow-up imaging appointments will have to be at the primary clinical location.

To be eligible for OPT-IN, patients must have gallbladder cancer that was discovered incidentally at the time of or following non-urgent gallbladder removal. Any spread of cancer to nearby tissue or lymph nodes must be able to be removed by surgery. They must not have any signs that the disease has spread to other distant places in the body (i.e. advanced or metastatic).

Learn more about EA2197/OPT-IN at ecog-acrin.org.