Compare the efficacy of adjuvant chemotherapy with Cisplatin or Carboplatin and Gemcitabine versus Gemcitabine in patients with resected or ablated intra-hepatic cholangiocarcinoma.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Arm A: Carboplatin or Cisplatin every 21 days for 6 cycles. Dose based on weight.
Arm A: Cisplatin or Carboplatin every 21 days for 6 cycles. Dose based on weight.
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.
University of Louisville
Louisville, Kentucky, United States
Overall Survival
Time frame: Every three months for 4 years
Progression Free Survival
Time frame: Every three months for 4 years.
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