MedTrace Logo

A Study of Cisplatin or Carboplatin With Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Patients With Resected or Ablation Intra-Hepatic Cholangiocarcinoma

NCT03081039 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2018-02-19

No results posted yet for this study

Summary

Compare the efficacy of adjuvant chemotherapy with Cisplatin or Carboplatin and Gemcitabine versus Gemcitabine in patients with resected or ablated intra-hepatic cholangiocarcinoma.

Conditions

  • Intrahepatic Cholangiocarcinoma

Interventions

DRUG

Carboplatin

Arm A: Carboplatin or Cisplatin every 21 days for 6 cycles. Dose based on weight.

DRUG

Cisplatin

Arm A: Cisplatin or Carboplatin every 21 days for 6 cycles. Dose based on weight.

DRUG

Gemcitabine

Arm A: Given with either Cisplatin or Carboplatin every 21 days for 6 weeks. Dose based on individuals weight. Arm B: Gemcitabine alone every 21 days for 6 cycles. Dose based on weight.

Sponsors & Collaborators

  • University of Louisville

    lead OTHER

Principal Investigators

  • Robert Martin, MD, PhD · University of Louisville

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-21
Primary Completion
2022-04-28
Completion
2022-12-31
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 NCT03081039 on ClinicalTrials.gov