Split-course SBRT for Borderline Resectable and Locally Advanced Pancreatic Cancer
NCT ID: NCT04289792
Last Updated: 2023-02-16
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE2
Total Enrollment
27 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-05-09
Study Completion Date
2025-05-09
Brief Summary
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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).
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Treatment
COMPLETED
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Detailed Description
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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.
Conditions
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Pancreatic Neoplasms
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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SBRT with concurrent chemotherapy
SBRT with nab-Paclitaxel plus Gemcitabine (nab-P+Gem) chemotherapy
Group Type
EXPERIMENTAL
nab-Paclitaxel+Gemcitabine
Intervention Type
DRUG
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 SBRT
Intervention Type
RADIATION
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).
Interventions
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nab-Paclitaxel+Gemcitabine
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.
Intervention Type
DRUG
split-course SBRT
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).
Intervention Type
RADIATION
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Fujian Medical University Union Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Benhua Xu
Director
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Benhua Xu, PHD
Role: PRINCIPAL_INVESTIGATOR
Fujian Medical University Union Hospital
Locations
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Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Site Status
RECRUITING
Countries
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China
Central Contacts
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Facility Contacts
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References
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Reference Type
DERIVED
Other Identifiers
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splitPC
Identifier Type: -
Identifier Source: org_study_id
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COMPLETED
EARLY_PHASE1
Radiotherapy to Patients With CA19-9-elevated Advanced Pancreatic Cancer
NCT06250972
RECRUITING
PHASE3
Evaluation of SBRT for Patients With Locally Advanced Unresectable Pancreatic Cancer
NCT03158779
COMPLETED
PHASE2
Nab-Paclitaxel Plus Gemcitabine With Concurrent MR-Guided IMRT in Patients With Locally Advanced Pancreatic Cancer
NCT02283372
COMPLETED
PHASE1
SBRT and Anti-programmed Cell Death Protein 1(Anti-PD-1) in Late Stage or Recurrent Pancreatic Cancer Patients
NCT03716596
TERMINATED
PHASE1
Re-irradiation With Stereotactic Body Radiotherapy for Relapsed Pancreatic Cancer
NCT02745847
UNKNOWN
NA
A Dose Escalation Trial of Stereotactic Body Radiotherapy (SBRT) After Induction Chemotherapy for Locally Advanced Pancreatic Cancer
NCT02643498
COMPLETED
PHASE1
A Phase II Study to Assess the Efficacy and Safety of Preoperative Chemo With Radiation Therapy for Patients With Borderline Unresectable Adenocarcinoma of the Pancreas
NCT01240304
TERMINATED
PHASE2
Safety and Efficacy Study of Nab-paclitaxel Plus Gemcitabine in Chinese Patients With Metastatic Pancreatic Cancer
NCT02017015
COMPLETED
PHASE2
Stereotactic Body Radiotherapy Dose Escalation in Pancreatic Cancer
NCT02454140
COMPLETED
NA
Different Patterns of Target Delineation in SBRT for Locally Advanced Pancreatic Cancer
NCT04699539
COMPLETED
NA
Neoadjuvant S-1 and Concurrent Radiotherapy for Borderline Resectable Pancreatic Cancer
NCT02459652
COMPLETED
PHASE2
GTX-RT in Borderline Resectable Pancreatic Cancer
NCT01754623
TERMINATED
PHASE2
Immunotherapy and SBRT Study in Borderline Resectable Pancreatic Cancer
NCT02405585
TERMINATED
PHASE2
Study of Gemcitabine Plus Nab-paclitaxel Versus S1 Plus Nab-paclitaxel in Metastatic Adenocarcinoma of the Pancreas
NCT03779464
UNKNOWN
PHASE2
Stereotactic Body Radiation Therapy Followed by NALIRIFOX vs NALIRIFOX for Borderline Resectable Pancreatic Cancer
NCT06259058
NOT_YET_RECRUITING
PHASE1/PHASE2
Role of Cyberknife Stereotactic Radiation Therapy (SBRT) Followed by Gemcitabine for Patients With Locally Advanced Pancreatic Cancer
NCT01304160
COMPLETED
PHASE1/PHASE2
Phase II Neoadjuvant Chemotheraphy (Gemcitabine and Nab-Paclitaxel vs. mFOLFIRINOX) and Sterotatic Body Radiation Therapy for Borderline Resectable Pancreatic Cancer
NCT02241551
TERMINATED
PHASE2
AG vs mFOLFIRINOX as Neoadjuvant Therapy for Borderline Reseactable and Locally Advanced Pancreatic Cancer
NCT04617821
UNKNOWN
PHASE3
The Safety and Efficacy of the Combination of Raltitrexed for Injection and Nab-Paclitaxel in Advanced Pancreatic Cancer
NCT04581876
UNKNOWN
PHASE2
Clinical Study of Carbon Ion Radiotherapy for Pancreatic Cancer.
NCT06840067
RECRUITING
NA