Sponsor: ECOG-ACRIN Cancer Research Group
Sponsor Study ID: EA2197
Study Title: Optimal Perioperative Therapy for Incidental Gallbladder Cancer (OPT IN) A Randomized Phase II/III Trial
CTO #: 103419
NCT Number: NCT04559139
Phase: II/III
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Other Digestive Organ
Study Objectives: This phase II/III trial compares the effect of adding chemotherapy before and after surgery versus after surgery alone (usual treatment) in treating patients with stage II-III gallbladder cancer. 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. Additionally, it may make it easier for the surgeon to distinguish between normal and cancerous tissue. Giving chemotherapy after surgery may kill any remaining tumor cells. 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.