Clinical trial · Interventional
Split-course SBRT for Borderline Resectable and Locally Advanced Pancreatic Cancer
Chemotherapy-based Split Stereotactic Body Radiation Therapy for Borderline Resectable and Locally Advanced Pancreatic Cancer: Study Protocol of a Prospective, Single-arm Phase II Trial
NCT04289792CI-TRIAL-00063980unknownPhase 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)
Exploratory assessment of the efficacy and safety of gemcitabine-albumin-based paclitaxel chemotherapy combined with SBRT in the treatment of newly diagnosed borderline resectable and locally advanced unresectable pancreatic cancer patients with sequential investigator selection (IC).
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 Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nab-Paclitaxel+Gemcitabine | Drug | — | UNRESOLVED |
| split-course SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SBRT with concurrent chemotherapy
- description
- SBRT with nab-Paclitaxel plus Gemcitabine (nab-P+Gem) chemotherapy
- interventionNames
- Drug: nab-Paclitaxel+Gemcitabine
- Radiation: split-course SBRT
Primary outcomes (1)
- measure
- Kaplan-Meier Estimate of Progression-Free Survival (PFS)
- timeFrame
- From enrollment to 2 years after the end of treatment
- description
- Progression-free Survival (PFS) was defined as the time from the date of the first dose to the date of disease progression or death (by any cause), whichever is earlier. The analysis day was calculated from enrollment date for one participant who was not treated. Participants who have no disease progression or have not died were censored to last tumor assessment date with progression-free.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years old and ≤ 70 years old. * Histologically or cytologically confirmed adenocarcinoma of the pancreas. * Borderline resectable or locally advanced pancreatic cancer proven by imaging examinations via multidisciplinary approaches according to NCCN guidelines * No prior chemotherapy or radiotherapy * ECOG performance status of 0 or 1. * Without distant metastasis * The maximum diameter of the tumor must not exceed 5 cm * Acceptable hematology parameters: a. Absolute neutrophil count (ANC) ≥1500 cell/mm3 b. Platelet count ≥100,000/mm3 c. Hemoglobin (Hgb)≥9 g/dL * Acceptable blood chemistry levels: a. AST/SGOT and ALT/SGPT≤2.5× upper limit of normal range (ULN) b. Total bilirubin≤1.5 ULN c. Alkaline phosphatase≤2.5× ULN d. Serum albumin\>3 g/dL e. Serum creatinine≤1.5 ULN * Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted. Exclusion Criteria: * Age \< 18 years old and \> 70 years old. Prior anticancer therapy for pancreatic carcinoma. * Presence of or history of metastatic pancreatic adenocarcinoma. * Patients who had surgeries, chemotherapy, or other treatments before inclusion. * Any other malignancy within 5 years prior to enrollment * History of allergy or hypersensitivity to nab-paclitaxel or gemcitabine or any of their excipients. * Peripheral sensory neuropathy Grade \> 1 * Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders. * Pregnant or breast feeding. * Patients enrolled in other clinical trials or incompliant with regular follow-up * Unwillingness or inability to comply with study procedures.
References
Publications (51)
- BACKGROUNDSiegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5. PMID 28055103
- BACKGROUNDChen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25. PMID 26808342
- BACKGROUNDSaif MW. Pancreatic neoplasm in 2011: an update. JOP. 2011 Jul 8;12(4):316-21. PMID 21737886
- BACKGROUNDOettle H, Neuhaus P, Hochhaus A, Hartmann JT, Gellert K, Ridwelski K, Niedergethmann M, Zulke C, Fahlke J, Arning MB, Sinn M, Hinke A, Riess H. Adjuvant chemotherapy with gemcitabine and long-term outcomes among patients with resected pancreatic cancer: the CONKO-001 randomized trial. JAMA. 2013 Oct 9;310(14):1473-81. doi: 10.1001/jama.2013.279201. PMID 24104372
- BACKGROUNDRegine WF, Winter KA, Abrams R, Safran H, Hoffman JP, Konski A, Benson AB, Macdonald JS, Rich TA, Willett CG. Fluorouracil-based chemoradiation with either gemcitabine or fluorouracil chemotherapy after resection of pancreatic adenocarcinoma: 5-year analysis of the U.S. Intergroup/RTOG 9704 phase III trial. Ann Surg Oncol. 2011 May;18(5):1319-26. doi: 10.1245/s10434-011-1630-6. Epub 2011 Mar 10. PMID 21499862
- BACKGROUNDMichelakos T, Pergolini I, Castillo CF, Honselmann KC, Cai L, Deshpande V, Wo JY, Ryan DP, Allen JN, Blaszkowsky LS, Clark JW, Murphy JE, Nipp RD, Parikh A, Qadan M, Warshaw AL, Hong TS, Lillemoe KD, Ferrone CR. Predictors of Resectability and Survival in Patients With Borderline and Locally Advanced Pancreatic Cancer who Underwent Neoadjuvant Treatment With FOLFIRINOX. Ann Surg. 2019 Apr;269(4):733-740. doi: 10.1097/SLA.0000000000002600. PMID 29227344
- BACKGROUNDGao 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.