Clinical trial · Interventional
Internal Radiation Therapy With Y-90 Microspheres, External Radiation Therapy With Tomotherapy, and Fluorouracil in Treating Patients With Newly Diagnosed or Recurrent Pancreatic Cancer and Liver Metastases That Cannot Be Removed By Surgery
Phase II Study of SIRT and SERT With Chemotherapy in Patients With Recurrent /Metastatic Pancreatic Cancer
- 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)
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy in different ways and giving it together with chemotherapy may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving internal radiation therapy and external radiation therapy together with fluorouracil works in treating patients with newly diagnosed or recurrent pancreatic cancer and liver metastases that cannot be removed by surgery.
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 |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil | Drug | Fluorouracil | ALIAS |
| selective external radiation therapy | Radiation | — | UNRESOLVED |
| tomotherapy | Radiation | — | UNRESOLVED |
| yttrium Y 90 glass microspheres | Radiation | — | UNRESOLVED |
| yttrium Y 90 resin microspheres | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Tumor response
- measure
- Hepatic and systemic toxicity
Secondary outcomes (2)
- measure
- Time to progression
- measure
- Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed pancreatic cancer with liver metastases
* Unresectable disease AND meets any of the following criteria:
* Newly diagnosed disease
* No prior treatment
* Received prior treatment and progressed
* Underwent prior pancreatectomy and progressed
* Liver-only disease (receives selective internal radiotherapy only)
* No known CNS metastases
* No known diffuse peritoneal metastases
PATIENT CHARACTERISTICS:
* Karnofsky performance status 80-100%
* Life expectancy \> 3 months
* WBC ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 9 g/dL
* Bilirubin \< 2 mg/dL (without extrahepatic biliary obstruction)
* Albumin \> 2 g/dL
* Creatinine \< 2 mg/dL
* Not pregnant
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Prior surgery, chemotherapy, and biologic therapy allowed
* No prior external beam radiotherapy to liver or pancreatic bedReferences
Publications (0)
Data not yet available