Clinical trial · Interventional
Dose Escalation/De-escalation Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases(RAD 1002)
RAD 1002: Phase I Dose Escalation/De-escalation Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases
NCT01252797CI-TRIAL-00032911RAD 1002completedPhase 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)
This study will investigate the safety, tolerability, and effectiveness of changing the order of receiving radiation therapy for treating brain cancer. The investigators hope that changing the sequence of radiation therapy will lower the risk of cancer spreading throughout your spinal fluid, which covers your brain and spinal cord.
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 |
|---|---|---|---|
| Brain Metastases | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Radiosurgery (12 Gy) | Radiation | — | UNRESOLVED |
| Stereotactic Radiosurgery (15 Gy) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Stereotactic Radiosurgery (15 Gy)
- description
- Group A: If the tumor which will be surgically removed is at least 2 cm and up to 4 cm in maximum diameter, then this group will receive Dose Level II (15 Gy) of radiation: stereotactic radiosurgery (SRS) followed by surgery to remove the tumor.
- interventionNames
- Radiation: Stereotactic Radiosurgery (15 Gy)
- type
- EXPERIMENTAL
- label
- Stereotactic Radiosurgery (12Gy)
- description
- Group B: If the tumor which will be surgically removed is larger than 4 cm and up to 6 cm in diameter, then this group will receive Dose Level I (12 Gy) of radiation: stereotactic radiosurgery (SRS) followed by surgery to remove the tumor.
- interventionNames
- Radiation: Stereotactic Radiosurgery (12 Gy)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * All subjects must have history of histologically confirmed malignancy. Brain biopsy is not required unless diagnosis is judged to be in doubt by the treating physician. * Newly diagnosed brain metastases (four or fewer by post-contrast MRI obtained within six weeks of study entry) * At least one brain metastasis (index tumor) must be within 2-6 cm in maximum diameter and deemed appropriate for surgical resection by the treating neurosurgeon. * Karnofsky performance status (KPS) of greater than or equal to 60 * Age greater than 19 * Life expectancy greater than 12 weeks * Subjects given written informed consent Exclusion Criteria: * Patients with small cell lung cancer and lymphoma are ineligible. * More than four metastases by baseline post-contrast MRI * Prior whole brain radiation therapy * Insufficient recovery from all active toxicities of prior therapies * Subjects who are deemed to be poor surgical risks by the treating neurosurgeon because of medical comorbidities * Pregnant or nursing women * Women of childbearing potential who are not using an effective method of contraception are excluded. Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to administration of SRS.
References
Publications (0)
Data not yet available
No reference posted for this study.