Clinical trial · Interventional
Re-irradiation With Stereotactic Body Radiotherapy for Relapsed Pancreatic Cancer
The Safety and Efficacy of Re-irradiation With Stereotactic Body Radiotherapy for Relapsed Pancreatic Cancer
NCT02745847CI-TRIAL-00066718unknownN/AClinicalTrials.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 re-irradiation with stereotactic body radiotherapy for relapsed pancreatic cancer 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 |
|---|---|---|---|
| Re-irradiation with SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Re-irradiation with SBRT
- description
- Patients with relapsed pancreatic cancer meeting all inclusion criteria will receive re-irradiation with SBRT.
- interventionNames
- Radiation: Re-irradiation with SBRT
Primary outcomes (1)
- measure
- The toxicities following SBRT will be determined.
- timeFrame
- 3 years
- description
- The toxicities following SBRT will be assessed by CTCAE v4.0
Secondary outcomes (5)
- measure
- Overall survival
- timeFrame
- 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age≥18 2. KPS≥70 3. Pancreatic malignancy need to be confirmed by histological or cytological valuation or clinical diagnosis (MDT with typical clinical manifestations, radiological features of pancreatic cancer via MRI and PET-CT). 4. Patients were previously treated with SBRT in Shanghai Changhai hospital 5. The time from the end of prior SBRT to local recurrence is more than 6 months 6. In-field recurrences of pancreatic cancer confirmed by Imaging examinations. 7. Blood routine examination: Absolute neutrophil count (ANC) ≥ 1.5 ×10\^9/L, leukocyte count≥ 3.5 ×10\^9/L, platelets ≥ 70×10\^9/L, hemoglobin ≥ 80 g/L 8. Blood routine examination: Absolute neutrophil count (ANC) ≥ 1.5 ×10\^9/L, leukocyte count≥ 3.5 ×10\^9/L, platelets ≥ 70×10\^9/L, hemoglobin ≥ 80 g/L 9. INR \< 2 (0.9-1.1), PPT \<1.5 × ULN 10. Ability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Age\<18 2. KPS\<70 3. Prior anti-tumor treatment (surgery, chemotherapy, radiation etc.) for the relapsed pancreatic cancer. 4. Evidences of metastatic disease or invasion of the stomach or duodenum confirmed by Imaging examinations. 5. The time from the end of prior SBRT to local recurrence is less than 6 months 6. Patients with active inflammatory bowel diseases or peptic ulcer 7. Gastrointestinal bleeding or perforation within 6 months 8. Abnormal results of blood routine examinations and liver and kidney tests 9. Female who is pregnant or nursing, or is of childbearing potential and not using a reliable method of contraception 10. Patients with a history of any other malignancy (except basal cell carcinoma and carcinoma in situ of cervix) 11. Contraindication to SBRT 12. Inability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document
References
Publications (20)
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- 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
- 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
- BACKGROUNDHUGUET F H P V D. Impact of chemoradiation on local control and time without treatment in patients with locally advanced pancreatic cancer included in the international phase III LAP 07 study. Journal of Clinical Oncology 5s(32): 4001, 2014.
- BACKGROUNDMoningi S, Marciscano AE, Rosati LM, Ng SK, Teboh Forbang R, Jackson J, Chang DT, Koong AC, Herman JM. Stereotactic body radiation therapy in pancreatic cancer: the new frontier. Expert Rev Anticancer Ther. 2014 Dec;14(12):1461-75. doi: 10.1586/14737140.2014.952286. Epub 2014 Sep 3. PMID 25183386
- BACKGROUNDBerber B, Sanabria JR, Braun K, Yao M, Ellis RJ, Kunos CA, Sohn J, Machtay M, Teh BS, Huang Z, Mayr NA, Lo SS. Emerging role of stereotactic body radiotherapy in the treatment of pancreatic cancer. Expert Rev Anticancer Ther. 2013 Apr;13(4):481-7. doi: 10.1586/era.13.19. PMID 23560842
- BACKGROUNDYechieli RL, Robbins JR, Mahan M, Siddiqui F, Ajlouni M. Stereotactic Body Radiotherapy for Elderly Patients With Medically Inoperable Pancreatic Cancer. Am J Clin Oncol. 2017 Feb;40(1):22-26. doi: 10.1097/COC.0000000000000090.