Clinical trial · Interventional
Radiation Therapy With or Without Radiosurgery in Treating Patients With Brain Metastases
A PHASE III TRIAL COMPARING WHOLE BRAIN IRRADIATION WITH VERSUS WITHOUT STEREOTACTIC RADIOSURGERY BOOST FOR PATIENTS WITH ONE TO THREE UNRESECTED BRAIN METASTASES
NCT00002708CI-TRIAL-00012687completedPhase 3ClinicalTrials.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: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether giving radiation therapy during surgery is more effective than standard radiation therapy in treating brain metastases. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without radiosurgery in treating patients with brain metastases that cannot be removed during surgery.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiation therapy | Radiation | — | UNRESOLVED |
| stereotactic radiosurgery | Radiation | — | UNRESOLVED |
| surgical procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Whole brain radiation therapy (WBRT) to 37.5 Gy/15 fractions/2.5 Gy once daily, 5 days/week followed by radiosurgery to all metastases
- interventionNames
- Procedure: surgical procedure
- Radiation: radiation therapy
- Radiation: stereotactic radiosurgery
- type
- ACTIVE_COMPARATOR
- label
- Arm 2
- description
- WBRT to 37.5 Gy/15 fractions/2.5 Gy once daily, 5 days/week
- interventionNames
- Radiation: radiation therapy
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: No more than 1 unresected or subtotally resected brain metastasis lesion from histologically confirmed systemic malignancy Eligible only if surgical resection refused by patient or resection deemed inappropriate by patient's physician 1 intraparenchymal metastasis clearly defined on contrast enhanced MRI Maximum diameter of lesion no greater than 4.0 cm No leukemia or lymphoma Extracranial sites of primary metastatic disease allowed if no clinical or radiographic evidence of progression within 1 month prior to entry No metastasis to brainstem, midbrain, pons, or medulla No leptomeningeal metastasis by MRI or CSF evaluation No metastasis within 10 mm of optic nerves and chiasm (area must be excluded from high dose stereotactic radiosurgery boost field) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 70-100% Karnofsky Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 50,000/mm3 Hemoglobin at least 8 g/dL Hepatic: Not specified Renal: Not specified Other: Neurologic status 0-2 No major medical or psychiatric contraindication to protocol entry Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent chemotherapy for systemic cancer Endocrine therapy: Concurrent hormonal therapy, including tamoxifen, allowed Radiotherapy: No prior cranial radiotherapy Surgery: Prior subtotal resection allowed Other: No other concurrent treatment for brain metastasis until recurrence
References
Publications (4)
- RESULTHazard LJ, Jensen RL, Shrieve DC. Role of stereotactic radiosurgery in the treatment of brain metastases. Am J Clin Oncol. 2005 Aug;28(4):403-10. doi: 10.1097/01.coc.0000158438.79665.bb. PMID 16062084
- RESULTAndrews DW, Scott CB, Sperduto PW, Flanders AE, Gaspar LE, Schell MC, Werner-Wasik M, Demas W, Ryu J, Bahary JP, Souhami L, Rotman M, Mehta MP, Curran WJ Jr. Whole brain radiation therapy with or without stereotactic radiosurgery boost for patients with one to three brain metastases: phase III results of the RTOG 9508 randomised trial. Lancet. 2004 May 22;363(9422):1665-72. doi: 10.1016/S0140-6736(04)16250-8. PMID 15158627
- RESULTSperduto PW, Scott C, Andrews D: Stereotactic radiosurgery with whole brain radiation therapy improves survival in patients with brain metastases: report of Radiation Therapy Oncology Group phase III study 95-08. [Abstract] Int J Radiat Oncol Biol Phys 54(2 suppl 1): 3, 2002.
- RESULTSperduto P, Scott C, Andrews D, et al.: Preliminary report of RTOG 95-08: a phase III trial comparing whole brain irradiation alone versus whole brain irradiation plus stereotactic radiosurgery for patients with two or three unresected brain metastases. [Abstract] Int J Radiat Oncol Biol Phys 48: A-6, 113, 2000.