Clinical trial · Interventional
Study To Establish Maximum Tolerated Dose (MTD) of Cyberknife in Patients With Un-Resectable Pancreas Cancer (TL002)
Phase I Study To Establish Maximum Tolerated Dose (MTD) of Cyberknife in Patients With Un-Resectable Pancreas Cancer (TL002)
NCT02707328CI-TRIAL-00039791terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Closed after being on administrative hold
Summary
Brief summary (as posted)
This study is looking at determining the maximum safe dose of CyberKnife when given with chemotherapy for unresectable 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CyberKnife | Radiation | — | UNRESOLVED |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- description
- Chemotherapy: Gemcitabine 1000 mg/m2 and Abraxane 125 mg/m2 weekly x3 of 28 day cycle Radiation: 20-55 GY over 5 fractions Dosing schedule: 3 cycles of chemotherapy, followed by CyberKnife, followed by 3 additional cycles of chemotherapy.
- interventionNames
- Drug: Gemcitabine
- Drug: nab-paclitaxel
- Radiation: CyberKnife
Primary outcomes (1)
- measure
- Maximum tolerable dose
- timeFrame
- 4-7 months
- description
- This study is to evaluate the MTD for Cyberknife when given in conjunction with Gemcitabine and Abraxane.
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 * Unresectable disease based on the following imaging criteria (table 1) * extrapancreatic extension * tumor involvement of the SMA or celiac axis * evidence of occlusion of the SMV-portal vein confluence * KPS \> 50 (ECOG 0-2) * 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. * Note that patients with metastatic disease are eligible if it is felt that the patients will benefit from local control of the primary disease. * Disease that is measureable or evaluable for response endpoint per RECIST Exclusion Criteria: * Prior radiotherapy to the upper abdomen * Resectable or borderline resectable pancreas cancer. Note that these patients are eligible for a separate study looking at radiosurgery for borderline resectable pancreas cancer * Severe comorbidity rendering a candidate ineligible for chemotherapy or radiation, 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 of childbearing age who are unwilling or unable to practice contraception * Inability to undergo MRI or CT with contrast for treatment planning * Patients may not be receiving any other investigational nor commercial agents with therapeutic intent to treat pancreatic cancer while on this trial. Note that patients can have had previous investigational therapy but cannot have this concurrently with this protocol treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.