EA2197 Chemotherapy Before and After Versus After Surgery for Gallbladder Cancer - Clinical Trial
What is the 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.
What is the Condition Being Studied?
Gallbladder Cancer (found after gallbladder was removed during surgery)
Who Can Participate in the Study?
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.
Age Group
Adults
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:
- 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
Gastrointestinal Surgeon
Protocol Number
IRB:
PRO00111186
NCT:
NCT04559139
Phase
Phase
II/III
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment