Split-course SBRT For Borderline Resectable And Locally Advanced Pancreatic Cancer

Study Overview

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

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).

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.

Pancreatic Neoplasms

DRUG: nab-Paclitaxel+Gemcitabine
RADIATION: split-course SBRT

splitPC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-02-20	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-02-14
First Submitted that Met QC Criteria 2020-02-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-02-16
First Posted (ACTUAL) 2020-02-28	Results First Posted N/A	Last Verified 2023-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: SBRT with concurrent chemotherapy SBRT with nab-Paclitaxel plus Gemcitabine (nab-P+Gem) chemotherapy	DRUG: 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. RADIATION: 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).

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: SBRT with concurrent chemotherapy

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

DRUG: 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.

RADIATION: 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).

Primary Outcome Measures	Measure Description	Time Frame
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.	From enrollment to 2 years after the end of treatment

Secondary Outcome Measures	Measure Description	Time Frame
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.	From enrollment to 2 years after the end of treatment
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.	From enrollment to 2 years after the end of treatment
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.	From enrollment to 2 years after the end of treatment
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).	From enrollment to 2 years after the end of treatment
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.	From enrollment to 2 years after the end of treatment

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Benhua Xu, PHD

Phone Number: +86-13696884375

Email: benhuaxu@163.com

Study Contact Backup

Name: Rong Zheng, PHD

Phone Number: +86 18659103321

Email: zhengrrong@outlook.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Benhua Xu, PHD, Fujian Medical University Union Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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