Clinical trial NCT02529774: Alternating Systemic and Hepatic Artery Infusion Therapy As Adjuvant Treatment After Resection of Liver Metastases From Colorectal Cancer
Official title: Efficacy and Safety of Alternating Systemic and Hepatic Artery Infusion Therapy Versus Systemic Chemotherapy Alone As Adjuvant Treatment After Resection of Liver Metastases From Colorectal Cancer: A Randomized, Parallel-Group, Open-Labelled, Active-Controlled Phase II/III Trial in China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Resected Liver Metastases From Colorectal Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2015-08-20
Enrollment: 432
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This adaptive seamless Phase II/III trial is to compare the efficacy and safety of adjuvant systemic chemotherapy (SCT) with or without hepatic arterial infusion (HAI) after complete hepatic resection for Chinese patients with metastatic colorectal cancer.


Eligibility criteria: Diagnosis Criteria:

All patients should have histologically confirmed colorectal adenocarcinoma with hepatic metastases and primary tumours completely resected during the operation and with colorectal metastatic to the liver confirmed pathologically after the operation as well as with negative surgical margin.

Main criteria for inclusion:

* Aged 18-75 years
* Diagnosed as colorectal adenocarcinoma which only spread to the liver and with no extra-hepatic metastases
* Prior curative resection of primary tumours (R0 resection) or concurrent feasible curative resection of primary tumours and hepatic metastases (R0 resection is met)
* Performance status ECOG 0-1
* No serious complication occurred during or after metastases resection and affected subsequent treatment.
* Hematology: White blood count ≧ 4.0X10\^9/L, Absolute neutrophil count ≧1.5X10\^9/L, Platelet count ≧ 100 X10\^9/L, Hemoglobin ≧ 100g/L
* Blood biochemistry: Total bilirubin ≦2mg/dL , Direct bilirubin equal or less than 1.5 times upper limit of normal (ULN), Alanine aminotransferase (ALT) no greater than 2.5 times ULN, Aspartate aminotransferase (AST) no greater than 2.5 times ULN, Serum creatinine no greater than ULN, or glomerular filtration rate equal or greater than 60 mL/min/1.73m\^2
* Not pregnant or nursing at present
* Fertile patients must use effective contraception
* Able to withstand major operative procedure
* No prior or concurrent malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of any organ
* No prior hepatic artery infusion therapy with 5-FU or floxuridine
* No prior systemic chemotherapy for metastatic disease
* No other concurrent chemotherapy
* Able to understand and sign off informed consent form

Primary outcomes:
measure: Overall Survival
timeFrame: 5-year
measure: Liver Relapse-Free Survival Rate
timeFrame: 3-year
Secondary outcomes:
measure: Disease free survival
timeFrame: 3-year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center China
state: Shanghai
Study officials:
affiliation: Fudan University Shanghai Cancer Center China
name: Ye Xu, Dr.
role: PRINCIPAL_INVESTIGATOR
References: