Clinical trial · Interventional
Combination of SBRT With Sequential S-1 for Treating Locally Advanced Pancreatic Cancer
Stereotactic Body Radiation Therapy With Sequential S-1 for Patients With Locally Advanced Pancreatic Cancer and Poor Medical Conditions --a Phase II Clinical Trial
NCT02704143CI-TRIAL-00047705completedN/AResults postedClinicalTrials.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)
The safety and efficacy of combination of SBRT with sequential S-1 in treating patients with locally advanced pancreatic cancer and poor medical conditions will be evaluated.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| combination of Cyberknife with S-1 | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combination of Cyberknife with S-1
- description
- Patients with locally advanced pancreatic cancer meeting all inclusion criteria will receive combination of Cyberknife with S-1.
- interventionNames
- Other: combination of Cyberknife with S-1
Primary outcomes (1)
- measure
- One-year Overall Survival Rate
- timeFrame
- 1 year
- description
- One-year overall survival rate is calculated by the ratio of number of patients surviving more than 1 year to the total number of patients enrolled.
Secondary outcomes (5)
- measure
- Number of Participants With Acute Toxicities Following SBRT
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Locally advanced pancreatic cancer proved by CT or MRI and biopsy 2. Without any other treatment before SBRT 3. A life expectancy of \>3months 4. ECOG: 2 or 3 points 5. Age of more than 18 years old 6. Blood routine examination: Absolute neutrophil count (ANC) ≥ 1.5 ×10\^9 cells/L, leukocyte count≥ 3.5 ×10\^9 cells/L, platelets ≥ 70×10\^9 cells/L, hemoglobin ≥ 8.0 g/dl 7. Liver and kidney function tests: Albumin \> 2.5 g/dL, total bilirubin \< 3 mg/dL, creatinine \< 2.0 mg/dL, AST\<2.5 × ULN(Upper Limit of Normal)(0-64U/L), ALT\<2.5 × ULN(0-64U/L) 8. INR \< 2 (0.9-1.1) 9. Ability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Prior surgery, chemotherapy or radiation for the pancreatic cancer 2. Evidences of metastatic disease such as nodal or distant metastases by abdomen CT and chest CT or FDG PET-CT 3. Contraindication to receiving radiotherapy 4. ECOG: 0-1 point 5. Age\<18 6. Abnormal results of blood routine examinations and liver and kidney tests 7. Patients with active inflammatory bowel diseases or peptic ulcer 8. Gastrointestinal bleeding or perforation within 6 months 9. Heart failure: NYHA III-IV 10. Women who are pregnant 11. Participation in another clinical treatment trial while on study 12. Patients in whom fiducial implantation was not possible 13. Inability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document.
References
Publications (18)
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- BACKGROUNDSener SF, Fremgen A, Menck HR, Winchester DP. Pancreatic cancer: a report of treatment and survival trends for 100,313 patients diagnosed from 1985-1995, using the National Cancer Database. J Am Coll Surg. 1999 Jul;189(1):1-7. doi: 10.1016/s1072-7515(99)00075-7. PMID 10401733
- BACKGROUNDRichter A, Niedergethmann M, Sturm JW, Lorenz D, Post S, Trede M. Long-term results of partial pancreaticoduodenectomy for ductal adenocarcinoma of the pancreatic head: 25-year experience. World J Surg. 2003 Mar;27(3):324-9. doi: 10.1007/s00268-002-6659-z. Epub 2003 Feb 27. PMID 12607060
- BACKGROUNDTseng JF, Raut CP, Lee JE, Pisters PW, Vauthey JN, Abdalla EK, Gomez HF, Sun CC, Crane CH, Wolff RA, Evans DB. Pancreaticoduodenectomy with vascular resection: margin status and survival duration. J Gastrointest Surg. 2004 Dec;8(8):935-49; discussion 949-50. doi: 10.1016/j.gassur.2004.09.046. PMID 15585381
- BACKGROUNDHoyer M, Roed H, Sengelov L, Traberg A, Ohlhuis L, Pedersen J, Nellemann H, Kiil Berthelsen A, Eberholst F, Engelholm SA, von der Maase H. Phase-II study on stereotactic radiotherapy of locally advanced pancreatic carcinoma. Radiother Oncol. 2005 Jul;76(1):48-53. doi: 10.1016/j.radonc.2004.12.022. PMID 15990186
- BACKGROUNDBurris HA 3rd, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, Cripps MC, Portenoy RK, Storniolo AM, Tarassoff P, Nelson R, Dorr FA, Stephens CD, Von Hoff DD. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol. 1997 Jun;15(6):2403-13. doi: 10.1200/JCO.1997.15.6.2403. PMID 9196156
- Ueno H, Okusaka T, Ikeda M, Takezako Y, Morizane C. An early phase II study of S-1 in patients with metastatic pancreatic cancer. Oncology. 2005;68(2-3):171-8. doi: 10.1159/000086771. Epub 2005 Jul 4.