Clinical trial · Interventional
Palliative Stereotactic Radiation for Pancreatic or Periampullary Adenocarcinoma
Phase II Study to Evaluate Stereotactic Body Radiation Therapy For Palliative Management of Unresectable Recurrent or Residual Pancreatic or Periampullary Adenocarcinoma
NCT01781728CI-TRIAL-00092380completedPhase 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)
The investigators are looking to see if a certain dose of stereotactic body radiation therapy (SBRT) may be a viable treatment option for recurrent or residual pancreatic or periampullary adenocarcinoma.
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 |
| Periampullary Adenocarcinoma | Periampullary Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Locally advanced pancreatic cancer or locally recurrent pancreatic ductal adenocarcinoma
- description
- Patients with pathologically confirmed, locally advanced pancreatic ductal adenocarcinoma (LAPC), unresectable at diagnosis, or local recurrence pancreatic ductal adenocarcinoma (PDAC) after prior surgical resection.
- interventionNames
- Radiation: Stereotactic Body Radiation Therapy (SBRT)
Primary outcomes (1)
- measure
- Late Gastrointestinal Toxicities
- timeFrame
- 3 months post-treatment to date of first progression or date of death, whichever comes first assessed up to 36 months
- description
- Late (Up to 3 months post-treatment to date of first progression or date of death, (whichever comes first-up to 36 months) Grade 2 or greater gastritis, enteritis, fistula, or ulcer and any other grade 3 or greater gastrointestinal toxicity attributable to Stereotactic Body Radiation Therapy (SBRT). Toxicity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 4.0) and the Radiation Therapy Oncology Group radiation morbidity scoring criteria.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria:
* 18 years of age or older
* Karnofsky Performance Status greater than or equal to 70%
* confirmed pancreatic or periampullary adenocarcinoma
* pancreatic or periampullary tumor less than 8.0 cm in greatest axial dimension
* Either:
* standard of care treatment for pancreatic cancer that included radiation therapy
\* patients may be receiving continued chemotherapy post initial CRT. or
* standard of care treatment for pancreatic cancer that did not include radiation therapy \* patients must have attempted chemotherapy upon initial diagnosis
* acceptable organ and marrow function as determined by blood tests
* ability to understand and give consent
* must be a patient to be treated with SBRT only at Johns Hopkins Hospital
* life expectancy of greater than 3 months
Exclusion Criteria:
* extensive metastatic disease
* performance status of less than 70
* children are excluded form the study
* no uncontrolled intercurrent illness
* no concurrent malignancy other than melanoma
* pregnant or breast feeding women are excluded
* women who are not post-menopausal and have a positive pregnancy test
* life expectancy of less than 3 monthsReferences
Publications (0)
Data not yet available
No reference posted for this study.