Clinical trial · Interventional
Radiation Therapy in Treating Patients With Liver Metastases
A Phase I Trial of Highly Conformal Radiation Therapy for Patients With Liver Metastases
NCT00255814CI-TRIAL-00019811completedPhase 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: 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 I trial is studying the side effects and best dose of 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- Radiation therapy dose level II: 4.0 Gy/fx
- description
- Radiation therapy dose level II: 4.0 Gy/fraction
- interventionNames
- Radiation: radiation therapy
- type
- OTHER
- label
- Radiation therapy dose level III: 4.5 Gy/fx
- description
- Radiation therapy dose level III: 4.5 Gy/fraction
- interventionNames
- Radiation: radiation therapy
- type
- OTHER
- label
- Radiation therapy dose level IV: 5.0 Gy/fx
- description
- Radiation therapy dose level IV: 5.0 Gy/fraction
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following: * Histologically confirmed non-lymphoma liver metastases * New radiographic liver lesions most consistent with metastases in a patient with known, histologically proven non-lymphoma cancer AND a previously negative CT scan, MRI, or PET/CT scan of the liver * No more than 5 measurable lesions by contrast-enhanced liver CT scan, MRI, or PET/CT scan * Liver metastases ≤ 8 cm * Medically unfit for surgery OR lesions are surgically unresectable * All intrahepatic disease must be encompassed within the study radiation field * Extrahepatic disease outside the liver is allowed provided the hepatic disease is life-limiting * At least 1,000 cc of normal liver * No clinical ascites * No CNS metastases PATIENT CHARACTERISTICS: Performance status * Zubrod 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,800/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 8 g/dL (transfusion allowed) Hepatic * No active hepatitis * No clinically significant liver failure * No underlying cirrhosis Renal * Not specified Cardiovascular * No congestive heart failure requiring hospitalization within the past 6 months * No unstable angina pectoris requiring hospitalization within the past 6 months * No transmural myocardial infarction within the past 6 months Pulmonary * No chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignancy within the past 3 years except non-melanomatous skin cancer or carcinoma in situ of the breast, oral cavity, cervix or primary liver metastasis * No acute bacterial or fungal infection requiring IV antibiotics PRIOR CONCURRENT THERAPY: Chemotherapy * At least 4 weeks since prior chemotherapy * No concurrent chemotherapy * No anthracyclines within 4 weeks after completion of study therapy (1 week for other chemotherapy) Radiotherapy * No prior radiotherapy to the region of study * No concurrent intensity-modulated radiotherapy Surgery * Prior liver resection or ablative therapy allowed Other * No concurrent warfarin or IV heparin
References
Publications (0)
Data not yet available
No reference posted for this study.