Clinical trial · Interventional
A Study of Pre-Operative Cyberknife in Patients With Potentially Resectable Pancreas Cancer
NCT02707315CI-TRIAL-00021346unknownEarly Phase 1ClinicalTrials.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 is evaluating stereotactic radiosurgery (CyberKnife) plus chemotherapy for the treatment of potentially resectable adenocarcinoma of the pancreas
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Pancreas | Pancreatic Adenocarcinoma | ALIAS | 0.90 |
| Pancreas Adenocarcinoma | Pancreatic Adenocarcinoma | ALIAS | 0.90 |
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Stereotactic Radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- description
- Chemotherapy: Gemcitabine 1000 mg/m2 weekly x 3 on 28 day cycle Radiation: 25 Gy over 5 fractions Surgery: surgical resection of pancreas treatment plan: 1 cycle of chemotherapy, followed by stereotactic radiosurgery, followed by an additional 6 cycles of chemotherapy or surgical resection
- interventionNames
- Drug: Gemcitabine
- Radiation: Stereotactic Radiosurgery
Primary outcomes (1)
- measure
- percentage of subjects who successfully undergo pancreaticoduodenectomy
- timeFrame
- 2 months
- description
- Evaluate the percentage of subjects who successfully undergo pancreaticoduodenectomy
Secondary outcomes (4)
- measure
- Overall Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed adenocarcinoma of the pancreas * Resectable or potentially resectable disease based on the following imaging criteria performed \< 4 weeks from study entry and as determined by local review (Cooper radiologist) * No extrapancreatic extension to nearby organs (ie; small bowel) * No SMV/PV \>180 degree involvement and/or reconstructable (as determined by Surgeon) occlusion * No SMA Abutment TVI\<180 degrees * No Celiac trunk abutment Total volume involved \< 180 degrees * Note that both resectable and potentially resectable patients are eligible * ECOG ≤ 2 * Adequate hematologic and end organ function as defined by * Hepatic transaminase levels \< 3 x normal * Total bilirubin \< 5 mg/dl (if stented) * Serum creatinine level \< 1.6 mg/dl * Absolute neutrophil count \> 1,500cells/mm3 * Platelet count \> 100,000 cells/mm3 * Medical status suitable for consideration of major pancreatic surgery * Age \>18 years * Women of childbearing age and male participants must practice adequate contraception (hormonal or barrier method of birth control; abstinence) prior to and throughout study treatment. * Life expectancy \> 3 months * Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: * Prior invasive malignancy within 5 years other than pancreatic adenocarcinoma * Prior radiotherapy to the upper abdomen * Severe comorbidity rendering a candidate ineligible for surgical resection * Local, regional or distant extrapancreatic disease * Patients of childbearing age who are unwilling or unable to practice contraception * Failure to meet any of the above eligibility criteria * Inability to undergo MRI with contrast for treatment planning * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Patients may not be receiving any other investigational nor commercial agents with therapeutic intent to treat pancreatic cancer while on this trial. * unresectable pancreatic cancer based on the following imaging criteria performed \< 4 weeks from study entry and as determined by local review (Cooper radiologist) * Extrapancreatic extension to nearby organs (ie; small bowel) * SMV/PV \>180 degree involvement and/or reconstructable (as determined by Surgeon) occlusion * SMA Abutment TVI\<180 degrees * Celiac trunk abutment Total volume involved \< 180 degrees * Distant metastases
References
Publications (0)
Data not yet available
No reference posted for this study.