Borderline Resectable Pancreatic Cancer Neoadjuvant Chemoradiotherapy Clinicaltrial-1

Pancreatic Cancer Clinical Trial

— BRPCNCC-1  

Official title:

Comparisons of Different Neoadjuvant Chemotherapy Regimens With or Without Stereotactic Body Radiation Therapy for Borderline Resectable Pancreatic Cancer: Study Protocol of a Prospective, Randomized Phase II Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03777462
• Other study ID #: ChanghaiH-PP04
• Status: Recruiting
• Phase: Phase 2
• Start date: April 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2023
• Source: Changhai Hospital
• Contact: Shiwei Guo, Doctor
• Phone: +8618621500666
• Email: gestwa[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age=18 years old and =80 years old;
• Histological proven pancreatic adenocarcinoma;
• Borderline resectable pancreatic cancer proven by imaging examinations via multidisciplinary 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 the upper limit of normal value;
• Normal kidney function: serum creatinine<1.5 times of the upper limit of normal value or creatinine clearance rate>45ml/min;
• No severe comorbidities.

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), coronary heart disease, myocardial infarction within 6 months, severe cardiac arrhythmia and respiratory 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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Neoadjuvant gemcitabine plus nab-paclitaxel
Neoadjuvant gemcitabine plus nab-paclitaxel is used in the intervention group for 3 cycles. Standard doses of gemcitabine and nab-paclitaxel are adopted. Surgical resection will be performed after neoadjuvant chemotherapy.
• Neoadjuvant gemcitabine plus nab-paclitaxel with SBRT
Neoadjuvant gemcitabine plus nab-paclitaxel with SBRT is used in the intervention group for 3 cycles. Standard doses of gemcitabine and nab-paclitaxel are adopted. The radiation dose of SBRT is 7.5-8Gy/f for 5 fractions. Surgical resection will be performed 3 weeks after SBRT.
• Neoadjuvant S-1 plus nab-paclitaxel with SBRT
Neoadjuvant S-1 plus nab-paclitaxel with SBRT is used in the intervention group for 3 cycles. Standard doses of gemcitabine and nab-paclitaxel are adopted. The radiation dose of SBRT is 7.5-8Gy/f for 5 fractions. Surgical resection will be performed 3 weeks after SBRT.

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall time	The time between operation and the death of patients	From date of randomization until the date of death from any cause, whichever came first, assessed up to 24 months
Secondary	Disease free time	The time between operation and the relapse or metastasis of tumors	From date of randomization until the date of first documented progression or metastasis, assessed up to 12 months