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

Study Overview
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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.

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.

Official Title
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A 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

Conditions
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Intrahepatic Cholangiocarcinoma

Intervention / Treatment
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* Drug: Carboplatin
* Drug: Cisplatin
* Drug: Gemcitabine


Participation Criteria
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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 Exclusion Criteria: Subjects will be eligible for the study if they meet all inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomized 1:1 to one of two treatment arms.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A<br>Cisplatin or Carboplatin with Gemcitabine for 6 cycles | Drug: Carboplatin<br>* Arm A: Carboplatin or Cisplatin every 21 days for 6 cycles. Dose based on weight.<br>Drug: Cisplatin<br>* Arm A: Cisplatin or Carboplatin every 21 days for 6 cycles. Dose based on weight.<br>Drug: Gemcitabine<br>* 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.<br>|
| Active Comparator: Arm B<br>Gemcitabine alone for 6 cycles | Drug: Gemcitabine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | Every three months for 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | Every three months for 4 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cholangiocarcinoma, gemcitabine, carboplatin, cisplatin