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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-21

Study Completion Date

2022-12-31

Brief Summary

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

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Detailed Description

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Phase III, multicenter, open label, randomized study of Cisplatin or Carboplatin with Gemcitabine versus Gemcitabine alone as adjuvant therapy in patients with resected or ablated intra-hepatic cholangiocarcinoma. Subjects will be randomized in a 1:1 fashion to Cisplatin or Carboplatin with Gemcitabine versus Gemcitabine alone.

Conditions

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Intrahepatic Cholangiocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects will be randomized 1:1 to one of two treatment arms.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

Cisplatin or Carboplatin with Gemcitabine for 6 cycles

Group Type ACTIVE_COMPARATOR

Carboplatin

Intervention Type DRUG

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

Cisplatin

Intervention Type DRUG

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

Gemcitabine

Intervention Type DRUG

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.

Arm B

Gemcitabine alone for 6 cycles

Group Type ACTIVE_COMPARATOR

Gemcitabine

Intervention Type DRUG

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.

Interventions

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Carboplatin

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

Intervention Type DRUG

Cisplatin

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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* At least 18 years of age, of any race or sex who are eligible to sign written consent and have undergone prior resection of histological evidence of intrahepatic cholangiocarcinoma
* Hematologic function: ANC ≥ 1.5 x 10 /L, platelets ≥ 75 x 10 /L, and hemoglobin \> 9 g/dL
* Adequate liver function as measured by: total bilirubin ≤ 2.0 mg/dl, AST and ALT ≤ 5 ULN, albumin ≥ 2.5 g/dl
* Adequate renal function as measured by: creatinine ≤ 2.9 mg/dl, \> 50 ml/min calculated by the C-G equation
* Non-pregnant women of child bearing potential and fertile men are required to use effective contraception (negative pregnancy test for women of child-bearing age)
* ECOG status ≤ 1 at screening

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No