Clinical trial · Interventional
Extracranial Stereotactic Radiosurgery in Treating Patients With Solid Tumors
A Phase I/II Dose-Escalation/Efficacy Study of Palliative Extracranial Radiosurgery Using the Elektra Stereotactic Body Frame System
NCT00311597CI-TRIAL-00026439completedPhase 1 / Phase 2ClinicalTrials.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: Extracranial stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase I/II trial is studying the side effects and best dose of extracranial stereotactic radiosurgery and to see how well it works in treating patients with solid tumors.
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 |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiosurgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single fractionated radiation adjusted for tumor size
- description
- Single fractionated radiation adjusted for volume of tumor tissue encompassed by desired isodose line
- interventionNames
- Procedure: Radiosurgery
Primary outcomes (2)
- measure
- Maximum tolerated dose for up to 90 days after completion of study treatment
- timeFrame
- day 1 through 90
- measure
- Minimum dose required for local control as assessed by RECIST one-dimensional criterion and volumetric analysis for 90 days after completion of study treatment
- timeFrame
- day 1 through 90
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Presence of well-circumscribed tumor on contrast-enhanced CT scan or MRI * Maximum diameter of 6 cm PATIENT CHARACTERISTICS: * Life expectancy ≥ 3 months * Not pregnant * Fertile patients must use effective contraception * Negative pregnancy test * Must be able to tolerate CT scan or MRI contrast PRIOR CONCURRENT THERAPY: * At least 3 weeks since prior chemotherapy or immunotherapy * No prior treatment on this study * No chemotherapy or immunotherapy during and for 4 weeks after completion of study treatment * No concurrent external-beam radiotherapy overlapping with the radiosurgically-treated volume (including low-dose regions)
References
Publications (1)
- RESULTStieber VW, Hinson W, Kearns W, et al.: A phase I/II dose-escalation/efficacy study of palliative stereotactic body radiosurgery, including bioanatomic imaging to assess response. [Abstract] Int J Radiat Oncol Biol Phys 60 (1 Suppl 1): A-2381, S563-4, 2004.