Split-course SBRT for Borderline Resectable and Locally Advanced Pancreatic Cancer

Fujian Medical University Union Hospital27 enrolled

Overview

Exploratory assessment of the efficacy and safety of gemcitabine-albumin-based paclitaxel chemotherapy combined with SBRT in the treatment of newly diagnosed borderline resectable and locally advanced unresectable pancreatic cancer patients with sequential investigator selection (IC).

The question of how to administer adequate chemotherapy to synchronize SBRT treatment strategy to maximize the benefits of neoadjuvant therapy for improved prognosis of patients with borderline resectable (BRPC) and locally advanced (LAPC) pancreatic cancer is a challenging and debatable issue. No studies have yet evaluated the efficacy of split-course SBRT as the neoadjuvant chemoradiotherapy regimen. The investigators aimed to study whether neoadjuvant chemotherapy plus split-course SBRT results in better outcomes in BRPC and LAPC patients.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Neoplasms

Interventions

nab-Paclitaxel+GemcitabineDRUG

Drug: nab-Paclitaxel 125 mg/m2 IV over approximately 30-45 min on Days 1 and 15, followed by gemcitabine 1000 mg/m2 IV infusion over approximately 30 min on Days 1 and 15 of each 28-day cycle for 6 cycles.

split-course SBRTRADIATION

Radiation: During the first 1 and 2 cycles of chemotherapy, SBRT was given as a single irradiation of 10 Gy ⅹ 4 times (Days 2 and 16 of each 28-day cycle).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years old and ≤ 70 years old. * Histologically or cytologically confirmed adenocarcinoma of the pancreas. * Borderline resectable or locally advanced pancreatic cancer proven by imaging examinations via multidisciplinary approaches according to NCCN guidelines * No prior chemotherapy or radiotherapy * ECOG performance status of 0 or 1. * Without distant metastasis * The maximum diameter of the tumor must not exceed 5 cm * Acceptable hematology parameters: a. Absolute neutrophil count (ANC) ≥1500 cell/mm3 b. Platelet count ≥100,000/mm3 c. Hemoglobin (Hgb)≥9 g/dL * Acceptable blood chemistry levels: a. AST/SGOT and ALT/SGPT≤2.5× upper limit of normal range (ULN) b. Total bilirubin≤1.5 ULN c. Alkaline phosphatase≤2.5× ULN d. Serum albumin\>3 g/dL e. Serum creatinine≤1.5 ULN * Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted. Exclusion Criteria: * Age \< 18 years old and \> 70 years old. Prior anticancer therapy for pancreatic carcinoma. * Presence of or history of metastatic pancreatic adenocarcinoma. * Patients who had surgeries, chemotherapy, or other treatments before inclusion. * Any other malignancy within 5 years prior to enrollment * History of allergy or hypersensitivity to nab-paclitaxel or gemcitabine or any of their excipients. * Peripheral sensory neuropathy Grade \> 1 * Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders. * Pregnant or breast feeding. * Patients enrolled in other clinical trials or incompliant with regular follow-up * Unwillingness or inability to comply with study procedures.

Locations (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

RECRUITING

Outcomes

Primary Outcomes

Kaplan-Meier Estimate of Progression-Free Survival (PFS)

Progression-free Survival (PFS) was defined as the time from the date of the first dose to the date of disease progression or death (by any cause), whichever is earlier. The analysis day was calculated from enrollment date for one participant who was not treated. Participants who have no disease progression or have not died were censored to last tumor assessment date with progression-free.