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Chemotherapy Before & After Surgery in Patients With Resectable Gallbladder Cancer

NCT03579758 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2020-06-05

No results posted yet for this study

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.

Conditions

  • 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

Interventions

DRUG

Capecitabine

Given PO

DRUG

Cisplatin

Given IV

DRUG

Gemcitabine

Given IV

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Shishir K. Maithel, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-03
Primary Completion
2020-06-01
Completion
2020-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03579758 on ClinicalTrials.gov