Clinical trial · Interventional
Stereotactic Radiosurgery for Patients With Hepatic Metastases.
A Phase I Trial of Stereotactic Radiosurgery for Patients With Hepatic Metastases (SBRT Liver)
NCT00547677CI-TRIAL-00037108completedPhase 1ClinicalTrials.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)
RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with liver metastases.
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 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| stereotactic radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Maximum tolerated dose of stereotactic radiosurgery as assessed by NCI CTCAE v3.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed primary cancer
* Stage IV primary disease with up to five liver metastases that are visualized on CT scan, MRI of the abdomen, or positron-emission tomography
* No liver metastases secondary to germ cell tumor or hematologic malignancy
* Other sites of metastases allowed
* No malignant ascites
* The cumulative total dose of radiotherapy to ≥ 2/3 of the liver and surrounding normal tissues, including the esophagus, stomach, and small bowel, must be ≤ 15 Gy
* Percutaneous or laparoscopic biopsy of the metastasis and placement of 3-5 fiducials required if undergoing Cyberknife for treatment delivery
PATIENT CHARACTERISTICS:
* Karnofsky performance status 60-100%
* Life expectancy ≥ 3 months
* Albumin ≥ 3 g/dL
* Alkaline phosphatase \< 1.5 times upper limit of normal (ULN)
* AST and ALT \< 1.5 times ULN
* Total bilirubin \< 1.5 times ULN
* Prothrombin time \< 1.5 times ULN
* Hemoglobin \> 10 g/dL
* Platelet count \> 100,000/mm³
* ANC \> 1,000/mm³
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No history of diagnosed inflammatory bowel disease, such as ulcerative colitis or Crohn's disease
* No active peptic ulcer disease
* No hepato-renal syndrome
PRIOR CONCURRENT THERAPY:
* Prior systemic therapy allowed provided complete blood cell counts have recovered
* No other concurrent antineoplastic treatmentReferences
Publications (0)
Data not yet available
No reference posted for this study.