Clinical trial · Interventional
Borderline Resectable Pancreatic Cancer Neoadjuvant Chemoradiotherapy Clinicaltrial-1
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
NCT03777462CI-TRIAL-00069271BRPCNCC-1unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoadjuvant gemcitabine plus nab-paclitaxel | Drug | — | UNRESOLVED |
| Neoadjuvant gemcitabine plus nab-paclitaxel with SBRT | Drug | — | UNRESOLVED |
| Neoadjuvant S-1 plus nab-paclitaxel with SBRT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Group A of neoadjuvant chemotherapy
- description
- Neoadjuvant gemcitabine plus nab-paclitaxel is used in this group. Intravenous administration of gemcitabine (1000mg/m2) and nab-paclitaxel (125 mg/m2) are initiated on day 1, 8 and 15 during each 4-week cycle, which will repeat for 3 cycles. And surgical resection is performed after completion of the whole chemotherapy.
- interventionNames
- Drug: Neoadjuvant gemcitabine plus nab-paclitaxel
- type
- EXPERIMENTAL
- label
- Group B of neoadjuvant chemoradiotherapy
- description
- Neoadjuvant gemcitabine plus nab-paclitaxel with SBRT is used in this group. Intravenous administration of gemcitabine (1000mg/m2) and nab-paclitaxel (125 mg/m2) are initiated on day 1, 8 and 15 during each 4-week cycle, which will repeat for 3 cycles. After completion of the whole chemotherapy, patients will first receive PET-CT to exclude distant metastases and then undergo SBRT. The prescribed dose is 7.5-8Gy/f for 5 fractions. Dose constraints of normal tissues are referred to the American Association of Physicists in Medicine guidelines in TG-101. And surgical resection is performed 3 weeks after SBRT.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDGao 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. PMID 30917842