Clinical trial NCT04289792: Split-course SBRT for Borderline Resectable and Locally Advanced Pancreatic Cancer
Official title: Chemotherapy-based Split Stereotactic Body Radiation Therapy for Borderline Resectable and Locally Advanced Pancreatic Cancer: Study Protocol of a Prospective, Single-arm Phase II Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pancreatic Neoplasms
Lead sponsor: Fujian Medical University Union Hospital
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 unresectable pancreatic cancer patients with sequential investigator selection (IC).

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Kaplan-Meier Estimate of Progression-Free Survival (PFS)
timeFrame: From enrollment to 2 years after the end of treatment
Secondary outcomes:
measure: Kaplan-Meier Estimates for Time to Treatment Failure (TTF)
timeFrame: From enrollment to 2 years after the end of treatment
measure: Disease Control Rate (DCR)
timeFrame: From enrollment to 2 years after the end of treatment
measure: Overall Response Rate (ORR)
timeFrame: From enrollment to 2 years after the end of treatment
measure: Kaplan-Meier Estimates for Overall Survival (OS)
timeFrame: From enrollment to 2 years after the end of treatment
measure: Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: From enrollment to 2 years after the end of treatment
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
affiliation: Fujian Medical University Union Hospital
name: Benhua Xu, PHD
role: PRINCIPAL_INVESTIGATOR
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