Clinical trial · Interventional
Stereotactic Body Radiotherapy Dose Escalation in Pancreatic Cancer
Phase I Trial of Adaptive Stereotactic Body Radiotherapy (SBRT) Dose Escalation in Pancreatic Cancer
NCT02454140CI-TRIAL-00095042SBRTcompletedN/AResults 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 is to determine the maximum tolerated dose (MTD) of five fraction stereotactic radiotherapy (SBRT) in 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- SBRT 40 Gy in 5 fractions
- interventionNames
- Radiation: SBRT
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- SBRT 45 Gy in 5 fractions (starting dose level)
- interventionNames
- Radiation: SBRT
- type
- EXPERIMENTAL
- label
- Cohort 3
- description
- SBRT 50 Gy in 5 fractions
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis: Histologically-proven invasive adenocarcinoma of the pancreas. * Disease Status: Medically unresectable (any stage), or locally advanced (stage III). * Tumor Location: Primary tumor may be located anywhere in the pancreas. * Treatment eligibility: The patient must be able to have fiducial markers implanted into the pancreatic tumor, and receive radiation regimen as specified in the protocol. * Performance Level: Karnofsky Performance Status ≥ 60 * Adequate Renal Function Defined As: Serum creatinine ≤ 1.5 x upper limit of normal * Informed Consent: All subjects must sign a written informed consent. Exclusion Criteria: * Pregnancy or Breast-Feeding: Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events. (Note: Serum Pregnancy tests must be obtained in women of child bearing potential). Sexually active females may not participate unless they have agreed to use an effective contraceptive method (such as abstinence, diaphragm, condom, or intrauterine device) to prevent pregnancy for the duration of the study. * Life expectancy \< 6 months * The patient cannot have had prior radiation therapy to the thorax or upper abdomen. * Incarcerated individuals * Subjects unable to give informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.