Chemotherapy Before & After Surgery in Patients With Resectable Gallbladder Cancer
Stage I Gallbladder Cancer AJCC v8, Stage II Gallbladder Cancer AJCC v8, Stage IIA Gallbladder Cancer AJCC v8
About this trial
This is an interventional treatment trial for Stage I Gallbladder Cancer AJCC v8
Eligibility Criteria
Inclusion Criteria:
- Histologically-confirmed T1b, T2 or T3 gallbladder cancer discovered incidentally at the time of or following routine cholecystectomy for presumed benign disease
- Resectable disease at the time of enrollment based on high-quality, preoperative, cross-sectional imaging of the chest, abdomen, and pelvis (C/A/P)
- Enrollment and randomization within 12 weeks of initial cholecystectomy
- High-quality cross-sectional imaging (computed tomography [CT] or magnetic resonance imaging [MRI]) performed within 4 weeks prior to enrollment
- Able to give informed consent
- Able to adhere to study visit schedule and other protocol requirements
- Eastern Cooperative Oncology Group (ECOG) performance status of < 2
- Absolute neutrophil count ≥ 1500/mm³
- Platelet count ≥ 100,000/mm³
Exclusion Criteria:
- Patients with histologically-confirmed Tis, T1a, or T4 tumors
- Unresectable gallbladder cancer at the time of enrollment based on high-quality, preoperative, cross-sectional imaging of the C/A/P
- Unable to sign informed consent
- Serum creatinine > 1.5 x upper limit of normal or estimated creatinine clearance (CrCl) < 45 ml/min
- Serum total bilirubin > 1.5 x upper limit of normal
- Presence of active infection
- Pregnant and/or breastfeeding
- Known dihydropyrimidine dehydrogenase deficiency
Sites / Locations
- Stanford Cancer Institute Palo Alto
- Emory University Hospital Midtown
- Emory University Hospital/Winship Cancer Institute
- Emory Saint Joseph's Hospital
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm I (capecitabine)
Arm II (chemotherapy, capecitabine)
Participants undergo re-resection (including partial liver resection and portal lymph node dissection). Participants then receive capecitabine PO BID on days 1-14. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Participants receive cisplatin IV over 1 hour and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Within 10 weeks of chemotherapy, participants undergo re-resection (including partial liver resection and portal lymph node dissection). Participants then receive capecitabine PO BID on days 1-14. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.