Chemotherapy Before & After Surgery in Patients With Resectable Gallbladder Cancer



Status:Not yet recruiting
Healthy:No
Age Range:18 - Any
Updated:2/22/2019
Start Date:March 15, 2019
End Date:March 31, 2026
Contact:Shishir K. Maithel, MD
Email:smaithe@emory.edu
Phone:404-778-2670

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Perioperative Chemotherapy Prior To and After Reoperation for Incidental Gallbladder Cancer - An International, Randomized Phase III Trial

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.

PRIMARY OBJECTIVE:

I. To determine the difference in overall survival (OS) at 3 years for patients with
incidental gallbladder cancer (IGBC) who receive neoadjuvant gemcitabine hydrochloride
(gemcitabine) and cisplatin (gem/cis) prior to reoperation followed by adjuvant capecitabine
compared to patients who receive only adjuvant capecitabine after reoperation.

SECONDARY OBJECTIVES:

I. To determine the difference in recurrence-free survival (RFS) at 1 year for patients with
IGBC who receive perioperative chemotherapy prior to and after re-operation compared to
patients who receive only adjuvant chemotherapy after reoperation.

II. To assess the clinical effect of perioperative chemotherapy compared to only adjuvant
chemotherapy after reoperation on resectability among 3 cohorts: all enrolled patients, all
patients who undergo staging laparoscopy, and all patients who undergo laparotomy.

III. To compare the incidence of residual disease at the time of re-resection between
patients who receive perioperative chemotherapy and those who receive only adjuvant
chemotherapy.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants undergo re-resection (including partial liver resection and portal lymph
node dissection) after incidental diagnosis of gallbladder cancer. Participants then receive
capecitabine orally (PO) twice daily (BID) on days 1-14. Treatment repeats every 21 days for
8 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Participants receive cisplatin intravenously (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.

After completion of study treatment, participants are followed up periodically for up to 3
years.

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
We found this trial at
3
sites
550 Peachtree St NE
Atlanta, Georgia 30308
(404) 686-4411
Principal Investigator: Shishir Maithel, MD
Phone: 404-686-0242
Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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Atlanta, Georgia 30322
Principal Investigator: Shishir Maithel, MD
Phone: 404-778-2670
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Atlanta, Georgia 30342
Principal Investigator: Shishir Maithel, MD
Phone: 678-843-7029
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