Clinical trial · Interventional
Study of Stereotactic Body Radiation Therapy in Patients With Intact Pancreatic Cancer
A Study of Stereotactic Body Radiation Therapy in Patients With Unresected Carcinoma of the Pancreas or Ampulla
NCT01342354CI-TRIAL-00092342completedPhase 1 / Phase 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 purpose of this study is to determine the highest tolerated dose of Stereotactic Body Radiation Therapy (SBRT) and also to determine the appropriate dose for intact pancreatic cancer.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Radiation 10 Gy | Radiation | — | UNRESOLVED |
| Stereotactic Radiation 12.5 Gy | Radiation | — | UNRESOLVED |
| Stereotactic Radiation 15 Gy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Stereotactic Radiation: 10 Gy x3
- description
- Level 1 - SBRT 10Gy in three doses over ten days (total 30 Gy).
- interventionNames
- Radiation: Stereotactic Radiation 10 Gy
- type
- EXPERIMENTAL
- label
- Stereotactic Radiation: 12.5 Gy x3
- description
- Level 2 - SBRT 12.5Gy in three doses over ten days (total 37.5 Gy).
- interventionNames
- Radiation: Stereotactic Radiation 12.5 Gy
- type
- EXPERIMENTAL
- label
- Stereotactic Radiation: 15 Gy x3
- description
- Level 3 - SBRT 15Gy in three doses over ten days (total 45 Gy).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically confirmed, unresected cancer of the pancreas or ampulla. The cancer may include any invasive histology (e.g. adenocarcinoma, neuroendocrine carcinoma). * Patients must have measurable radiographic disease.Patients with previous complete resection are only eligible if there is measurable radiographic disease which is clearly felt to represent locally recurrent disease. * Patients may receive any number of cycles of chemotherapy prior to treatment with SBRT, but not within 2 weeks of the first fraction of RT. * Age \> or = 18 years. * Eastern Cooperative Oncology Group (ECOG) performance status \< or = 2 (Karnofsky \> or = 60%) * Life expectancy of greater than 3 months. * Patients must have normal organ and marrow function. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Concurrent investigational therapy delivered over the period of treatment or observation (28 days post-RT) for dose limiting toxicity. * Prior radiation therapy to the abdominal area which would overlap with the proposed area of treatment. * Pregnancy. * Primary disease \> 7.5 cm in largest diameter as measured by CT or MRI. * Gross extension of tumor into the lumen of the duodenum. * 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. * Use of bevacizumab or vascular endothelial growth factor inhibitor chemotherapy within 3 months before RT or 6 months after RT.
References
Publications (0)
Data not yet available
No reference posted for this study.