Clinical trial NCT02635971: Intra-arterial Versus Intravenous Chemotherapy for Locally Advanced Pancreatic Cancer
Official title: A Randomized Controlled Phase II Study on Intra-arterial Versus Intravenous Chemotherapy Infusion With Gemcitabine and Oxaliplatin for Locally Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Carcinoma, Pancreatic
Keywords: transcatheter arterial infusion
randomized controlled trial
chemotherapy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2015-12-21
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to explore the efficacy and safety of intra- arterial infusion of gemcitabine and oxaliplatin in locally advanced pancreatic cancer. This protocol is overseen by the Fudan University Institutional Review Board which has Federal Wide Assurance through the U.S. Department of Health \& Human Services (Approved: April 25, 2002).

Detailed description: Primary Outcome Measures:

To compare the overall survival (OS) in patients with locally advanced pancreatic cancer treated with transcatheter arterial infusion (TAI) of chemotherapeutics or systemic delivered chemotherapy.

Secondary Outcome Measures:

To compare the progression free survival (PFS), objective response rate (ORR), quality of life (QoL), and adverse effects of treating locally advanced pancreatic cancer patients with TAI or systemic chemotherapy.

Exploratory Outcome Measures:

To evaluate the correlation between prognosis and expression of serum microRNAs of the patients.

Eligibility criteria: Inclusion Criteria:

* Histologically/cytologically confirmed unresectable locally advanced pancreatic adenocarcinoma.
* Measurable disease by RECIST criteria must be present.
* Karnofsky Performance Status ≥ 70
* Patients with adequate organ functions reflected by the laboratory criteria below:

Granulocytes ≥ 1,500/uL Hemoglobin ≥ 8.0 gm/dL Platelets ≥ 100,000/uL Serum creatinine \< 2.0 mg/dL Bilirubin \< 1.5 mg/dL SGPT \< 2.5 x normal Alk Phos \< 2.5 x normal

* Prior local therapy, e.g., radiation, is allowed provided that at least 4 weeks washout time is given.
* Patients with jaundice must have a biliary drainage decompression operation before recruitment.
* Patients must not be pregnant. Serum beta-HCG will be checked in all premenopausal patients.
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Subject with metastatic disease.
* Prior treatment with systemic chemotherapy.
* Known allergies to the gemcitabine, oxaliplatin or iodine contrast agent.
* Subject with Child-Pugh grade Class C hepatic impairment, active gastrointestinal bleeding, severe coagulation disorder that could not be corrected，or other contraindication for transcatheter infusion.
* Untreated or uncontrolled deep vein thrombosis, arterial thrombosis of lower extremity, or aneurysm.
* Concurrent infection requiring intravenous antibiotics.
* Skin injury or infection of groin area, or other situation that not appropriate for femoral artery puncture.
* Other serious illness or condition including cardiac disease including congestive heart failure (New York Heart Association Classification III or IV), active HIV infection/HIV disease, psychiatric disorders.
* Known central nervous system involvement and leptomeningeal disease
* Subject with previous or concurrent cancer that is distinct in primary site or histology from pancreatic adenocarcinoma except cervical carcinoma in situ, non-melanoma carcinoma of the skin or in situ carcinoma of the bladder. Any cancer curatively treated greater than 3 years prior to entry is permitted.
* Pregnant or lactating women.

Primary outcomes:
measure: Overall survival
timeFrame: From date of randomization until the date of death, assessed up to 100 months.
Secondary outcomes:
measure: Progression free survival
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Zhiqiang Meng, MD, Ph D
role: PRINCIPAL_INVESTIGATOR
References: