Clinical trial NCT03777462: Borderline Resectable Pancreatic Cancer Neoadjuvant Chemoradiotherapy Clinicaltrial-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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: pancreatic cancer
neoadjuvant chemotherapy
SBRT
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2018-12-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: Overall time
timeFrame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 24 months
Secondary outcomes:
measure: Disease free time
timeFrame: From date of randomization until the date of first documented progression or metastasis, assessed up to 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Changhai Hospital, Shanghai, China
name: Gang Jin, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gao S, Zhu X, Shi X, Cao K, Bian Y, Jiang H, Wang K, Guo S, Zhang H, Jin G. 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 (BRPCNCC-1). Radiat Oncol. 2019 Mar 27;14(1):52. doi: 10.1186/s13014-019-1254-8.