Stage III Gallbladder Cancer AJCC v8 Clinical Trial
Official title:
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.
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