Clinical trial · Interventional
Radiation Therapy With or Without RSR13 in Treating Patients With Brain Metastases
A Phase III, Randomized, Open-Label, Comparative Study of Standard Whole Brain Radiation Therapy With or Without RSR13 in Patients With Brain Metastases
NCT00005887CI-TRIAL-00053439completedPhase 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. Drugs such as RSR13 may make tumor cells more sensitive to radiation therapy. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the brain with or without RSR13 in treating patients who have brain metastases.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| efaproxiral | Drug | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Radiographically, histologically, or cytologically confirmed brain metastases with histologically or cytologically confirmed primary malignancy except the following: * Small cell lung cancer, germ cell tumors, and lymphomas * No leptomeningeal metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100% Life expectancy: * Not specified Hematopoietic: * Hemoglobin at least 10 g/dL * WBC at least 2,000/mm3 * Platelet count at least 75,000/mm3 Hepatic: * Bilirubin no greater than 2.0 mg/dL * ALT and AST no greater than 3 times upper limit of normal Renal: * Creatinine no greater than 2.0 mg/dL Pulmonary: * Forced vital capacity and forced expiratory volume at least 50% of normal in patients with significant intrathoracic tumor involvement, chronic obstructive pulmonary disease, interstitial lung disease, or pulmonary embolism * Resting and exercise oxygen saturation at least 90% on room air Other: * No other concurrent active malignancy from a second histologic site * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior biologic therapy or immunotherapy for brain metastases * At least 28 days since prior investigational biologic therapy Chemotherapy: * No prior chemotherapy for brain metastases * No chemotherapy for brain metastases for at least one month following radiation therapy * At least 7 days since prior chemotherapy for primary tumor or extracranial metastases * No planned chemotherapy during radiation therapy Endocrine therapy: * No prior hormonal therapy for brain metastases * Prior or concurrent corticosteroid therapy allowed Radiotherapy: * No prior whole brain radiotherapy for brain metastases * No prior stereotactic radiosurgery for brain metastases Surgery: * Prior surgery allowed for brain metastases if at least one measurable lesion remains Other: * At least 28 days since prior investigational drug or device * No prior RSR13
References
Publications (6)
- RESULTSuh JH, Stea B, Nabid A, Kresl JJ, Fortin A, Mercier JP, Senzer N, Chang EL, Boyd AP, Cagnoni PJ, Shaw E. Phase III study of efaproxiral as an adjunct to whole-brain radiation therapy for brain metastases. J Clin Oncol. 2006 Jan 1;24(1):106-14. doi: 10.1200/JCO.2004.00.1768. Epub 2005 Nov 28. PMID 16314619
- RESULTNabid A, Kresl J, Stea B, et al.: Standard whole brain radiation (WBRT) with supplemental oxygen (O2) with or without RSR13 (efaproxiral) in patients with brain metastases originating from NSCLC: results of a subgroup analysis. [Abstract] J Clin Oncol 22 (Suppl 14): A-7115, 645s, 2004.
- RESULTShaw E, Stea B, Pinter T, et al.: Pharmacokinetics (PK) of RSR13 (efaproxiral) predict survival in patients with brain metastases randomized to receive whole brain radiation therapy (WBRT) with or without RSR13 (REACH RT-009). [Abstract] J Clin Oncol 22 (Suppl 14): A-1561, 122s, 2004.
- RESULTStea B, Suh J, Shaw E, et al.: Efaproxiral (EFAPROXYN) as an adjunct to whole brain radiation therapy for the treatment of brain metastases originating from breast cancer: updated survival results of the randomized REACH (RT-009) study. [Abstract] Breast Cancer Res Treat 88 (1): A-4064, 2004.
- RESULTSuh J, Stea BD, Nabid A, et al.: Prognostic factors for survival in patients with brain metastases enrolled on a worldwide phase 3 randomized trial of 538 patients (study RSR13 RT-009). [Abstract] Int J Radiat Oncol Biol Phys 60 (1 Suppl 1): A-60, S165, 2004.
- RESULTSuh J, Stea B, Nabid A, et al.: Standard whole brain radiation therapy (WBRT) with supplemental oxygen (O2), with or without RSR13 (efaproxiral) in patients with brain metastases: results of the randomized REACH (RT-009) study. [Abstract] J Clin Oncol 22 (Suppl 14): A-1534, 115s, 2004.