Clinical trial NCT02548195: Oxaliplatin+Gemcitabine vs Capecitabine as Adjuvant Therapy for Intrahepatic Cholangiocarcinoma
Official title: Oxaliplatin Plus Gemcitabine Versus Capecitabine Alone as Adjuvant Treatment in the Prevention of Recurrence of Intrahepatic Cholangiocarcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cholangiocarcinoma
Keywords: GEMOX
intrahepatic cholangiocarcinoma
adjuvant therapy
oxaliplatin
gemcitabine
capecitabine
curative surgery
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2015-09-14
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate of adjuvant therapy using oxaliplatin and gemcitabine (GEMOX regimen) versus capecitabine alone chemotherapy in patients who underwent curative surgery for intrahepatic cholangiocarcinoma (ICC) -- a randomized control study.

Detailed description: chemotherapy: GEMOX vs capecitabine alone; adjuvant settings; primary endpoint: recurrence-free survival (RFS); second endpoint: overall survival after surgery (OS).

Eligibility criteria: Inclusion Criteria:

* ECOG PS≤1;
* pathologically confirmed adenocarcinoma of bile duct;
* R1 resection or R0 resection with these risk factors: lymph node metastasis, lymphatic vessel or blood vessel invasion, multiple tumors, tumor size \>5 cm, preoperative CA199\>200 U/mL.
* postoperative liver function Child Pugh Class A, leukocyte count\>1.5\*10\^9/L, platelet count\>100\*10\^9/L, serum alanine aminotransferase \<1.5\*ULN
* no tumor recurrence or metastasis on baseline examination
* no history of radiotherapy or intervention therapy

Exclusion Criteria:

* hepatocellular carcinoma, mixed carcinoma of ICC and HCC, or hilar cholangiocarcinoma
* distant metastasis
* prothrombin time \>14s
* severe cardiopulmonary dysfunction
* severe renal dysfunction
* bone marrow suppression before the initiation of therapy
* allergic to fluorouracil, gemcitabine, or platinum
* gemcitabine was used in combination with radiotherapy

Primary outcomes:
measure: Recurrence-free survival
timeFrame: from the date of surgery to the date of tumor recurrence up to 36 months after surgery
Secondary outcomes:
measure: Overall survival
timeFrame: from the date of surgery to the date of death up to 36 months after surgery
Other outcomes:
measure: Number of participants with adverse events and severe adverse events
timeFrame: from the date of first dosage to safety follow-up visit (30 days after the last dosage)
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Jinpei Huang
role: STUDY_DIRECTOR
References:
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citation: Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. doi: 10.1056/NEJMoa0908721.