Clinical trial · Interventional
Role of Cyberknife Stereotactic Radiation Therapy (SBRT) Followed by Gemcitabine for Patients With Locally Advanced Pancreatic Cancer
Phase I/II Study to Investigate the Role of Cyberknife Stereotactic Radiation Therapy (SBRT) Followed by Gemcitabine for Patients With Locally Advanced Pancreatic Cancer
NCT01304160CI-TRIAL-00023379completedPhase 1 / Phase 2ClinicalTrials.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 purpose of this study is to evaluate the efficacy and safety of stereotactic radiation therapy given in five fractions (30 Gray in 5 fractions) followed by gemcitabine in patients with locally advanced pancreatic cancer.
Conditions
Conditions (2)
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 |
| Unresectable Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| stereotactic body radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- strereotactic radiotherapy, gemcitabine
- description
- stereotactic radiotherapy (30Gray in 5 fractions) followed by gemcitabine
- interventionNames
- Radiation: stereotactic body radiotherapy
Primary outcomes (1)
- measure
- Number of participants with adverse events
- timeFrame
- one year
- description
- Acute and chronic toxicities will be evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0
Secondary outcomes (3)
- measure
- Quality of life
- timeFrame
- 3 monthly
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pancreatic Adenocarcinoma, histologically and/or cytologically proven * Locally advanced pancreatic cancer, surgically non resectable * No distant metastasis * Work-up including medical history, physical exam, biochemistry, chest X-ray, CT-scan of abdomen and pelvis * ECOG performance status : ≤ 2 * Primary tumor visible on CT-scan * Maximum tumor diameter of 6 cm (including primary tumor and regional lymph nodes) * White blood cell count \> 3000 /uL, Neutrophils \> 1500 /uL, Platelets \> 100 000/uL, Hemoglobin \> 95 mg/L, Total bilirubin \< 1,5 normal limit, AST/ALT \< 2,5 normal limit, normal creatinin * ≥ 18 years of age * Signed informed consent Exclusion Criteria: * Prior abdominal radiation therapy * Connective tissue disease (scleroderma, lupus) * Prior treatment for pancreatic cancer such as radiation therapy, chemotherapy or surgery.
References
Publications (0)
Data not yet available
No reference posted for this study.