EA2197 Chemotherapy Before and After Versus After Surgery for Gallbladder Cancer

Purpose of this Study

We are doing this study to compare the usual treatment (surgery plus chemotherapy afterward) to using chemotherapy both before and after surgery.

Who Can Participate?

Eligibility

Adults 18 years and older who:
  • Have histologically-confirmed T2 or T3 gallbladder cancer discovered at the time of or following routine cholecystectomy for presumed benign disease
  • Do not have any evidence of metastatic disease
For more information about who can join this study, contact the study team at 919-668-1861.

What is Involved?

Description

This study is divided into 2 groups. If you decide to participate, you will be randomized into 1 of the 2 groups below:
  • Group 1 (Control Arm - Arm A) receives surgery and then 6 months of chemotherapy (gemcitabine/ cisplatin) after surgery
  • Group 2 (Treatment Arm - Arm B) receives 3 months of chemotherapy before surgery, followed by 3 months of chemotherapy after surgery

Study Details

Full Title

ECOG-ACRIN EA2197 Optimal Perioperative Therapy for Incidental Gallbladder Cancer (OPT-IN)- A Randomized Phase II/III Trial

Principal Investigator

Michael
Lidsky

Protocol Number

PRO00111186

NCT ID

NCT04559139

Phase

II/III

Enrollment Status

Open to Enrollment
ClinicalTrials.gov