Borderline Resectable Pancreatic Cancer Neoadjuvant Chemoradiotherapy Clinicaltrial-1

Last updated: August 31, 2023
Sponsor: Changhai Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Pancreatic Cancer

Pancreatitis

Digestive System Neoplasms

Treatment

Neoadjuvant gemcitabine plus nab-paclitaxel

Neoadjuvant gemcitabine plus nab-paclitaxel with SBRT

Neoadjuvant S-1 plus nab-paclitaxel with SBRT

Clinical Study ID

NCT03777462
ChanghaiH-PP04
  • Ages 18-80
  • All Genders

Study Summary

This study is to investigate whether neoadjuvant chemotherapy plus SBRT results in better outcomes compared with neoadjuvant chemotherapy alone and also compare the efficacy of gemcitabine plus nab-paclitaxel with SBRT and S-1 plus nab-paclitaxel with SBRT.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age≥18 years old and ≤80 years old;
  • Histological proven pancreatic adenocarcinoma;
  • Borderline resectable pancreatic cancer proven by imaging examinations viamultidisciplinary approaches according to NCCN guidelines;
  • No prior chemotherapy or radiotherapy;
  • ECOG of 0 or 1;
  • Routine blood test: absolute neutrophil count>1500/mm3, platelet>100000/mm3;
  • Normal liver function: serum total bilirubin≤2.0mg/dl, ALT and AST<2.5 times of theupper limit of normal value;
  • Normal kidney function: serum creatinine<1.5 times of the upper limit of normal valueor creatinine clearance rate>45ml/min;
  • No severe comorbidities.

Exclusion

Exclusion Criteria:

  • Metastatic pancreatic cancer;
  • Patients who had surgeries, chemotherapy or other treatments before inclusion;
  • Impaired organ functions: heart failure (New York Heart Association III-IV), coronaryheart disease, myocardial infarction within 6 months, severe cardiac arrhythmia andrespiratory failure;
  • Confirmed other cancer within 5 years;
  • Pregnant women or lactating women;
  • Patients enrolled in other clinical trials or incompliant of regular follow up;
  • Patients who did not provide an informed consent.

Study Design

Total Participants: 150
Treatment Group(s): 3
Primary Treatment: Neoadjuvant gemcitabine plus nab-paclitaxel
Phase: 2
Study Start date:
April 01, 2019
Estimated Completion Date:
December 31, 2023

Study Description

This research study is a Phase II clinical trial that investigate whether neoadjuvant chemotherapy plus SBRT results in better outcomes compared with neoadjuvant chemotherapy alone and also compare the efficacy of gemcitabine plus nab-paclitaxel with SBRT and S-1 plus nab-paclitaxel with SBRT. It is known that neoadjuvant therapy is vital for improved survival, which has been confirmed in previous studies that neoadjuvant chemotherapy with or without radiotherapy provides superior overall compared with upfront surgery. However, question of whether the addition of radiotherapy to neoadjuvant chemotherapy can improve prognosis compared with chemotherapy alone is a challenging matter. Also, no studies have evaluated the efficacy of S-1 as the neoadjuvant chemotherapy regimen for BRPC albeit similar prognosis has been found between S-1 and gemcitabine in advanced pancreatic cancer. In this trial, patients with biopsy and radiographically confirmed BRPC will be randomly allocated into three groups: neoadjuvant gemcitabine plus nab-paclitaxel, neoadjuvant gemcitabine plus nab-paclitaxel with SBRT and neoadjuvant S-1 plus nab-paclitaxel with SBRT. Surgical resection will be performed 3 weeks after SBRT. The primary endpoint is overall survival. The secondary outcomes are progression free survival, pathological complete response rate, R0 resection rate and incidence of adverse effects. If results show the survival benefits of neoadjuvant chemotherapy plus SBRT and similar outcomes between S-1 and gemcitabine, it may provide evidence of clinical practice of this modality for BRPC.

Connect with a study center

  • Changhai Hospital

    Shanghai, Shanghai 200433
    China

    Active - Recruiting

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