Clinical trial · Interventional
A Phase I/II Dose Escalation Study Using Extracranial Stereotactic Radiosurgery to Control Pain
A Phase I/II Dose Escalation Study to Evaluate Pain Response Using Extracranial Stereotactic Radiosurgery to Treat Paraspinal Metastasis in Patients Who Have Received Prior Spinal Irradiation
NCT00802659CI-TRIAL-00016269terminatedN/AResults 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): Terminated due to low accrual
Summary
Brief summary (as posted)
This study will evaluate pain control and quality of life in patients with paraspinal metastases, who have receive previous radiation therapy to these lesions, using single dose stereotactic radiotherapy.
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 |
|---|---|---|---|
| Metastases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Group -1
- description
- 1000 cGY radiation
- interventionNames
- Radiation: Stereotactic radiotherapy
- type
- EXPERIMENTAL
- label
- Group 1
- description
- 1200 cGY radiation
- interventionNames
- Radiation: Stereotactic radiotherapy
- type
- EXPERIMENTAL
- label
- Group 2
- description
- 1400 cGY radiation
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 * Prior non-hematogenous, histologically proven malignancy (specific exclusions are multiple myeloma and lymphoma) * Pain attributable to one or two radiographically apparent metastatic lesion(s) amenable to ESRT * Have had prior radiation to area of spine felt to be cause of patient's pain * Zubrod performance status of 0-3 * Life expectancy of ≥ 3 months * Signed informed consent prior to registration to study * Radiographic evidence of stable disease outside of the spinal column for at least 6 weeks prior to study entry, as evaluated by pre-study imaging. Exclusion Criteria: * Women who are pregnant or nursing * Either 'no evidence of other active cancerous disease' or 'other sites of known disease are locally controlled' * No radiographic evidence of spinal instability (e.g. spinal cord compression requiring immediate surgical intervention) * No initiation of chemotherapy within 15 days of trial entry. * No plans for concomitant antineoplastic therapy (including standard fractionated RT, chemotherapy, biologic, vaccine therapy, or surgery) for at least 15 days following stereotactic radiosurgery. * No active systemic infection. * No evidence of myelopathy or cauda equina syndrome on clinical evaluation
References
Publications (0)
Data not yet available
No reference posted for this study.