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

Fujian Medical University (FJMU)

Status and phase

Enrolling

Phase 2

Conditions

Pancreatic Neoplasms

Treatments

Drug: nab-Paclitaxel+Gemcitabine

Radiation: split-course SBRT

Study type

Interventional

Funder types

Other

Identifiers

NCT04289792

splitPC

Details and patient eligibility

About

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).

Full description

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.

Enrollment

27 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.