Clinical trial · Interventional
Trilogy Stereotactic Body Radiotherapy for Pancreatic Cancer
Phase II Study to Evaluate the Efficacy of Trilogy Stereotactic Radiosurgery for Pancreatic Cancer
NCT00350142CI-TRIAL-00025956completedPhase 2Results 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)
This study will assess the efficacy of treating locally advanced pancreatic cancer using Stereotactic Body Radiotherapy (using Trilogy) and Gemcitabine
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 4D pancreatic protocol CT scan | Other | — | UNRESOLVED |
| FDG PET scan | Radiation | — | UNRESOLVED |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Stereotactic Body Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Stereotactic Body Radiotherapy
- description
- Patients will have a 4D pancreatic protocol CT and a FDG PET scan scan, both for planning purposes. An SBRT treatment plan will be developed based on tumor geometry and location. All patients will receive a single fraction of 25 Gy dose of Stereotactic Body Radiotherapy on Trilogy Linear Accelerator, followed by weekly Gemcitabine.
- interventionNames
- Radiation: Stereotactic Body Radiotherapy
- Drug: Gemcitabine
- Other: 4D pancreatic protocol CT scan
- Radiation: FDG PET scan
Primary outcomes (1)
- measure
- Rate of Local Control
- timeFrame
- up to 3 years
- description
- The proportion of patients with local control where local control is defined as no recurrence or disease progression in the primary disease site. Disease progression was defined using either the RECIST or Pet criteria. Using the RECIST criteria disease progression is defined as a more than 25% tumor increase by volume and/ or presence of a new lesion. Using the Pet criteria disease progression is defined as an increase in PET activity as compared to the scan used in the planning of the treatment; any subsequent increase in SUVmax was defined as local progression.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria:- Pancreatic tumors not to exceed 10 cm in greatest axial dimension * Histologically confirmed malignancies of the pancreas * Unresectable by CT criteria or exploratory laparotomy or laparoscopy * Patients with metastatic disease may be treated if they are symptomatic from the primary tumor * Performance status of 0, 1, or 2 * No chemotherapy two weeks prior or two weeks following radiosurgery Exclusion Criteria: * patients who have had prior radiotherapy to upper abdomen * patients receiving any prior pancreatic cancer therapy * children, pregnant, and breastfeeding women, and lab personnel are excluded * uncontrolled intercurrent illnesses * any concurrent malignancy
References
Publications (0)
Data not yet available
No reference posted for this study.