Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT03579758

Chemotherapy Before & After Surgery in Patients With Resectable Gallbladder Cancer

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

Status
Withdrawn
Phase
Phase 3
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Emory University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DRUGCapecitabineGiven PO
DRUGCisplatinGiven IV
DRUGGemcitabineGiven IV

Timeline

Start date
2019-04-03
Primary completion
2020-06-01
Completion
2020-06-01
First posted
2018-07-09
Last updated
2020-06-05

Locations

5 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03579758. Inclusion in this directory is not an endorsement.