Clinical trial · Interventional
Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Metastatic Tumors to the Liver
Phase II Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Metastatic Tumors to the Liver
NCT01030757CI-TRIAL-00018456terminatedPhase 2Results postedClinicalTrials.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): Low accrual rate
Summary
Brief summary (as posted)
The purpose of this study is to determine the response of liver tumors to radiation therapy using Tomotherapy.
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 |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tomotherapy treatment | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tomotherapy
- description
- Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV.
- interventionNames
- Radiation: Tomotherapy treatment
Primary outcomes (1)
- measure
- Tumor Response Rate (Complete Response + Partial Response).
- timeFrame
- 1 year
Secondary outcomes (1)
- measure
- Toxicity, Progression Free Survival, Clinical Benefit Rate (Complete Response + Partial Response + Stable Disease), Median Duration of Clinical Benefit, and Median Overall Survival of Subjects.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic confirmation of solid primary tumor metastatic to liver * Age greater than or equal to 18 years old * Zubrod performance status less than or equal to 1 * Negative pregnancy test for women of child bearing potential * Informed consent * Less than or equal to 3 liver metastases * Each lesion must be less than or equal to 6 cm in maximal diameter * No prior radiation to lesions being treated * Patient is not a surgical candidate or refuses surgery * Absolute neutrophil count ≥ 1800 * Platelets ≥ 100000 * Hemoglobin ≥8.0 * Systemic therapy (chemotherapy) completed at least 2 weeks prior to SBRT * At time of radiation treatment planning, at least 700 cc of normal liver must receive less than 15 Gy Exclusion Criteria: * Contraindications to radiation * Pregnant or lactating females who chose to breast feed * Patients must have recovered from toxicity of prior therapy * Any co morbid condition that' in the view of the attending physician' renders the patient at high risk from treatment complications * Patients currently receiving anticoagulation with coumadin or IV heparin * Liver cirrhosis * Clinical ascites * Bilirubin \> 3, Albumin \< 2.5, liver enzymes 3 times above normal, Creatinine \> 1.8
References
Publications (0)
Data not yet available
No reference posted for this study.