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

Primary Purpose

Pancreatic Neoplasms

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
nab-Paclitaxel+Gemcitabine
split-course SBRT
Sponsored by
Fujian Medical University Union Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Neoplasms

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Fujian Medical University Union HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SBRT with concurrent chemotherapy

Arm Description

SBRT with nab-Paclitaxel plus Gemcitabine (nab-P+Gem) chemotherapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Kaplan-Meier Estimates for Time to Treatment Failure (TTF)
TTF was defined as the time after the first dose of study therapy to discontinuation of study therapy due to disease progression, death by any cause, or the start of a new non-protocol-defined anticancer therapy/surgery.
Disease Control Rate (DCR)
DCR was defined as the percentage of participants with a CR or PR or SD from of date of first treatment to 16 weeks. Tumor assessments after start of non-protocol-defined anticancer therapy were excluded.
Overall Response Rate (ORR)
ORR was defined as the percentage of participants that achieved a combined incidence of complete (CR) and partial response (PR) using RECIST 1.1 guidelines as assessed by the investigator.
Kaplan-Meier Estimates for Overall Survival (OS)
Overall survival was defined as the time from the date of first dose of study therapy to the date of death (by any cause).
Participants With Treatment Emergent Adverse Events (TEAEs)
TEAEs are defined as any adverse event (AE) that begin or worsen on or after the start of study drug or procedure of the study period through the maximum duration of the period plus 28 days.

Full Information

First Posted
February 20, 2020
Last Updated
February 14, 2023
Sponsor
Fujian Medical University Union Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04289792
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 9, 2020 (Actual)
Primary Completion Date
May 9, 2024 (Anticipated)
Study Completion Date
May 9, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fujian Medical University Union Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SBRT with concurrent chemotherapy
Arm Type
Experimental
Arm Description
SBRT with nab-Paclitaxel plus Gemcitabine (nab-P+Gem) chemotherapy
Intervention Type
Drug
Intervention Name(s)
nab-Paclitaxel+Gemcitabine
Intervention Description
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
Radiation
Intervention Name(s)
split-course SBRT
Intervention Description
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).
Primary Outcome Measure Information:
Title
Kaplan-Meier Estimate of Progression-Free Survival (PFS)
Description
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.
Time Frame
From enrollment to 2 years after the end of treatment
Secondary Outcome Measure Information:
Title
Kaplan-Meier Estimates for Time to Treatment Failure (TTF)
Description
TTF was defined as the time after the first dose of study therapy to discontinuation of study therapy due to disease progression, death by any cause, or the start of a new non-protocol-defined anticancer therapy/surgery.
Time Frame
From enrollment to 2 years after the end of treatment
Title
Disease Control Rate (DCR)
Description
DCR was defined as the percentage of participants with a CR or PR or SD from of date of first treatment to 16 weeks. Tumor assessments after start of non-protocol-defined anticancer therapy were excluded.
Time Frame
From enrollment to 2 years after the end of treatment
Title
Overall Response Rate (ORR)
Description
ORR was defined as the percentage of participants that achieved a combined incidence of complete (CR) and partial response (PR) using RECIST 1.1 guidelines as assessed by the investigator.
Time Frame
From enrollment to 2 years after the end of treatment
Title
Kaplan-Meier Estimates for Overall Survival (OS)
Description
Overall survival was defined as the time from the date of first dose of study therapy to the date of death (by any cause).
Time Frame
From enrollment to 2 years after the end of treatment
Title
Participants With Treatment Emergent Adverse Events (TEAEs)
Description
TEAEs are defined as any adverse event (AE) that begin or worsen on or after the start of study drug or procedure of the study period through the maximum duration of the period plus 28 days.
Time Frame
From enrollment to 2 years after the end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benhua Xu, PHD
Phone
+86-13696884375
Email
benhuaxu@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rong Zheng, PHD
Phone
+86 18659103321
Email
zhengrrong@outlook.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benhua Xu, PHD
Organizational Affiliation
Fujian Medical University Union Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benhua Xu, PHD
Email
benhuaxu@163.com

12. IPD Sharing Statement

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

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