Clinical trial · Interventional
Internal Radiation Therapy in Treating Patients With Liver Metastases From Neuroendocrine Tumors
Clinical Trial of Sir-Spheres® in Patients With Symptomatic or Progressive Hepatic Metastases From Neuroendocrine Tumors
NCT00466856CI-TRIAL-00006953terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): due to slow accrual
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. PURPOSE: This phase II trial is studying how well internal radiation therapy works in treating patients with liver metastases from neuroendocrine tumors.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Islet Cell Tumor | Pancreatic Neuroendocrine Tumor | ALIAS | 0.90 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Pheochromocytoma | Adrenal Gland Pheochromocytoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| octreotide acetate | Drug | — | UNRESOLVED |
| yttrium Y 90 resin microspheres | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sir-Spheres
- interventionNames
- Drug: octreotide acetate
- Radiation: yttrium Y 90 resin microspheres
Primary outcomes (1)
- measure
- Tumor response
- timeFrame
- at 1 year or until intervening death
Secondary outcomes (3)
- measure
- Toxicity as measured by CTC v3.0
- timeFrame
- at 1 year or until intervening death
- measure
- Symptomatic relief as measured by Carcinoid Symptom Scale, SF-36 Pain scale, and SF-36 physical component summary
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Pathologically confirmed neuroendocrine tumor metastatic to the liver
* Well-differentiated or moderately well-differentiated neuroendocrine tumors
* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm with conventional techniques or ≥ 10 mm with spiral CT scan
* Symptomatic disease, meeting one of the following criteria:
* Refractory carcinoid symptoms, defined as Carcinoid Symptom Severity scale \> 2 despite use of octreotide acetate at ≥ 200 mcg subcutaneously three times daily (or 20 mg intramuscularly once monthly) for ≥ 4 weeks
* Evidence of radiographic progression with either of the following manifestations:
* Moderate-severe right upper quadrant pain and unintentional weight loss \> 10%
* Decline in Karnofsky performance status \> 10 points
* At least a 20% increase in the sum of the longest diameters of target lesions in the liver within the past 12 months
* No more than 75% replacement of normal liver by neuroendocrine tumor
* No more than 20% arteriovenous lung shunting on a technetium Tc 99m macro-aggregated albumin nuclear scan
* No equivocal, nonmeasurable, or nonevaluable liver metastasis
PATIENT CHARACTERISTICS:
* Karnofsky performance status 50-100%
* Life expectancy ≥ 6 months
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Creatinine ≤ 1.5 mg/dL
* Bilirubin ≤ 2.0 mg/dL
* Albumin ≥ 3.0 g/dL
* Absolute granulocyte count ≥ 1,500/mm³
* Platelet count ≥ 65,000/mm³
* Hemoglobin \> 9.0 g/dL
* INR ≤ 1.4
* No hepatic arterial anatomy that would preclude the administration of study treatment into the liver
* No nonmalignant disease that would preclude study participation
* No other malignancy within the past 5 years except for cured basal cell carcinoma of the skin or cured carcinoma in situ of the uterine cervix
PRIOR CONCURRENT THERAPY:
* Prior surgery, chemotherapy, or locally ablative technique for the liver cancer allowed
* No prior radiotherapy to the upper abdomen that includes the liver in the treatment field
* No investigational drug or agent/procedure (i.e., participation in another clinical trial) within the past 4 weeks
* No other specific anticancer treatment (other than octreotide acetate) during and for 3 months after completion of study therapyReferences
Publications (0)
Data not yet available
No reference posted for this study.