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:<ul>
<li>Have histologically-confirmed T2 or T3 gallbladder cancer discovered at the time of or following routine cholecystectomy for presumed benign disease</li>
<li>Do not have any evidence of metastatic disease</li></ul>
For more information about who can join this study, contact the study team at 919-668-1861.
<li>Have histologically-confirmed T2 or T3 gallbladder cancer discovered at the time of or following routine cholecystectomy for presumed benign disease</li>
<li>Do not have any evidence of metastatic disease</li></ul>
For more information about who can join this study, contact the study team at 919-668-1861.
What is Involved?
This study is divided into 2 groups. If you decide to participate, you will be randomized into 1 of the 2 groups below:<ul>
<li>Group 1 (Control Arm - Arm A) receives surgery and then 6 months of chemotherapy (gemcitabine/ cisplatin) after surgery</li>
<li>Group 2 (Treatment Arm - Arm B) receives 3 months of chemotherapy before surgery, followed by 3 months of chemotherapy after surgery</li></ul>
<li>Group 1 (Control Arm - Arm A) receives surgery and then 6 months of chemotherapy (gemcitabine/ cisplatin) after surgery</li>
<li>Group 2 (Treatment Arm - Arm B) receives 3 months of chemotherapy before surgery, followed by 3 months of chemotherapy after surgery</li></ul>
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