Clinical trial · Interventional
Stereotactic Radiotherapy (SBRT) in Patients With Locally Advanced Pancreatic Cancer (LAPC)
Stereotactic Radiotherapy (SBRT) in Patients With Locally Advanced Pancreatic Cancer (LAPC). A Danish Phase II Study
NCT03648632CI-TRIAL-00057947SBRT-PC-01completedN/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)
Stereotactic Radiotherapy (SBRT) in patients with locally advanced pancreatic cancer (LAPC). A Danish phase II study.
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 |
|---|---|---|---|
| Locally Advanced Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Stereotactic Radiotherapy
- description
- 50 Gy in 5 fractions within a total of 7 - 8 days
- interventionNames
- Radiation: Stereotactic Radiotherapy
Primary outcomes (1)
- measure
- Resection rate for all patients starting SBRT
- timeFrame
- 12 month
- description
- Resection rate for all patients starting SBRT
Secondary outcomes (7)
- measure
- 1 year survival for all patients starting SBRT
- timeFrame
- 12 month
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * LAPC (Karolinska Type B, C or D1) * Cytologically or histologically verified adenocarcinoma/carcinoma * Prior combination chemotherapy for 2-6 months (unless contraindicated) and no sign of progressive disease * The patient is medically operable (i.e. no co-morbidity which can preclude anaesthesia or surgery) * World Health Organization performance status 0-1 * Age ≥ 18 years * Adequate hepatic function: bilirubin \<3.0 x Upper Normal Limit, International Normalized Ratio \<1.6, Activated Partial Thromboplastin Time \< 1,5 x Upper Normal Limit. Patients with obstruction of bile duct or gut must be drained before start of therapy * Oral and written informed consent must be obtained prior to registration with planned date of first treatment within 14 days from registration. Exclusion Criteria: * M1 disease * Prior radiotherapy to abdominal cavity * Pregnancy or breast-feeding. Fertile patients must use adequate contraceptives * Severe uncontrolled concomitant illness (e.g. clinically significant cardiac disease or myocardial infarction within 12 months)
References
Publications (1)
- DERIVEDWeisz Ejlsmark M, Bahij R, Schytte T, Ronn Hansen C, Bertelsen A, Mahmood F, Bau Mortensen M, Detlefsen S, Weber B, Bernchou U, Pfeiffer P. Adaptive MRI-guided stereotactic body radiation therapy for locally advanced pancreatic cancer - A phase II study. Radiother Oncol. 2024 Aug;197:110347. doi: 10.1016/j.radonc.2024.110347. Epub 2024 May 28. PMID 38815694