Chemotherapy Before & After Surgery in Patients With Resectable Gallbladder Cancer

• Status: Withdrawn
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase III trial studies how well chemotherapy before and after surgery works in treating participants with gallbladder cancer that can be removed by surgery. Drugs used in chemotherapy, such as cisplatin, gemcitabine, and capecitabine, 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 and after surgery may kill more tumor cells.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Treatments: Capecitabine; Cisplatin; Gemcitabine

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