Status:
UNKNOWN
Split-course SBRT for Borderline Resectable and Locally Advanced Pancreatic Cancer
Lead Sponsor:
Fujian Medical University Union Hospital
Conditions:
Pancreatic Neoplasms
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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...
Detailed 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 resect...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 9 2025
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04289792
Start Date
May 9 2020
End Date
May 9 2025
Last Update
February 16 2023
Active Locations (1)
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1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350000