Clinical trial · Interventional
Stereotactic Radiation Therapy in Treating Patients With Liver Metastases
A Phase I Dose Finding Pilot Study of Stereotactic Body Radiotherapy for the Treatment of Liver Metastasis
NCT00567970CI-TRIAL-00035198completedPhase 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 radiation therapy 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 radiation therapy in treating patients with liver metastases.
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 |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| stereotactic body radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Maximum tolerated dose
Secondary outcomes (5)
- measure
- Toxicity profile
- measure
- Adverse events profile
- measure
- Quality of life as measured by the Brief Pain Inventory and Brief Fatigue Inventory
- measure
- Response profile
- measure
- Physical exam results
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Metastatic liver lesion ≤ 5 cm in dimension * Willing and able to undergo percutaneous placement of localization seeds PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Life expectancy ≥ 12 weeks * Platelet count ≥ 75,000/µL * Hemoglobin ≥ 9 g/dL * ANC ≥ 1,500/mL * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) * AST ≤ 3 x ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to complete questionnaires alone or with assistance * No medical, social, or economic circumstance, that is likely to prevent adherence with the protocol PRIOR CONCURRENT THERAPY: * No prior radiation therapy to the liver * No chemotherapy ≤ 4 weeks prior to registration * Able to safely go without chemotherapy for 4 weeks after stereotactic radiotherapy (e.g., patients must not have or need chemotherapy in the 8 weeks \[4 weeks prior to and 4 weeks after registration\] surrounding stereotactic radiotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.