Chemotherapy Before & After Surgery in Patients With Resectable Gallbladder Cancer
Withdrawn before enrolling · Phase 3
Conditions studied: Stage I Gallbladder Cancer AJCC v8, Stage II Gallbladder Cancer AJCC v8, Stage IIA Gallbladder Cancer AJCC v8, Stage IIB Gallbladder Cancer AJCC v8, Stage III Gallbladder Cancer AJCC v8, Stage IIIA Gallbladder Cancer AJCC v8, Stage IIIB Gallbladder Cancer AJCC v8
In brief
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.
Key facts
- Study ID
- NCT03579758
- Run by
- Emory University
- People needed
- 0
- Starts
- 2019-04-03
- Expected to finish
- 2020-06-01
- Last updated by the study team
- 2020-06-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Stanford Cancer Institute Palo Alto — Stanford, California, United States
- Emory University Hospital Midtown — Atlanta, Georgia, United States
- Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States
- Emory Saint Joseph's Hospital — Atlanta, Georgia, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
Full record on ClinicalTrials.gov
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