Neoadjuvant chemotherapy with SBRT for borderline resectable pancreatic cancer

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

This study is testing if adding a type of radiation therapy to chemotherapy can help people with borderline resectable pancreatic cancer live longer and have better treatment outcomes.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Changhai Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT03777462 on ClinicalTrials.gov

What this trial studies

This Phase II clinical trial investigates the effectiveness of neoadjuvant chemotherapy combined with stereotactic body radiation therapy (SBRT) in patients with borderline resectable pancreatic cancer. Participants will be randomly assigned to receive either neoadjuvant gemcitabine plus nab-paclitaxel, or the same regimen with SBRT, or S-1 plus nab-paclitaxel with SBRT. The primary goal is to assess overall survival, while secondary outcomes include progression-free survival and the rate of successful surgical resection. This study aims to determine if adding SBRT to chemotherapy improves patient outcomes compared to chemotherapy alone.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with histologically confirmed borderline resectable pancreatic adenocarcinoma and no prior chemotherapy or radiotherapy.

Not a fit: Patients with metastatic pancreatic cancer or those who have undergone previous treatments are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved survival rates for patients with borderline resectable pancreatic cancer.

How similar studies have performed: Previous studies have shown that neoadjuvant therapies can improve survival in pancreatic cancer, but the specific combination of SBRT with chemotherapy is still being evaluated.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai

• Changhai Hospital — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Gang Jin, Doctor — Changhai Hospital, Shanghai, China
• Study coordinator: Shiwei Guo, Doctor

Conditions Pancreatic Cancer; pancreatic cancer; neoadjuvant chemotherapy; SBRT