Clinical trial · Interventional
Adjuvant Radiation Therapy in Treating Patients With Brain Metastases
Phase III Trial on Convergent Beam Irradiation of Cerebral Metastases
NCT00002899CI-TRIAL-00007300terminatedPhase 3ClinicalTrials.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): Low accrual
Summary
Brief summary (as posted)
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Adjuvant radiation therapy may kill any remaining tumor cells following surgery or radiosurgery for brain metastases. PURPOSE: This randomized phase III trial is studying surgery or radiosurgery alone to see how well it works compared to surgery or radiosurgery and whole-brain radiation therapy in treating brain metastases in 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 |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
| stereotactic radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Survival with a WHO performance status 0-2 as measured by Logrank at 8 weeks after completion of study treatment, and then every 3 months until death
Secondary outcomes (6)
- measure
- Overall survival as measured by Logrank at 8 weeks after completion of study treatment, and then every 3 months until death
- measure
- Progression-free survival as measured by Logrank 8 weeks after completion of study treatment, and then every 3 months until death
- measure
- Time to neurological progression as measured by Logrank 8 weeks after completion of study treatment, and then every 3 months until death
- measure
- Acute toxicity as measured by EORTC and RTOG scale 8 weeks after completion of study treatment, and then every 3 months until death
- measure
- Late toxicity as measured by Subjective, Objective, Management and Analytic/Late Effects on Normal Tissues (SOMA/LENT) scale 8 weeks after completion of study treatment, and then every 3 months until death
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of brain metastases from a histologically confirmed primary or metastatic extracranial tumor, meeting 1 of the following criteria:
* Stable systemic cancer for the last 3 months (achieved by surgery, radiotherapy, chemotherapy, or hormonal therapy), defined as absence of symptomatic or radiological progression
* Asymptomatic synchronous primary tumor (treatable by surgery, radiotherapy, chemotherapy, or hormonal therapy)
* No metastases outside the CNS
* Unknown primary tumor
* Must have one to three brain lesions, confirmed by enhanced MRI prior to radiosurgery or surgery
* No brain stem metastases
* No leptomeningeal metastases
* No brain metastases from small cell lung cancer, lymphoma, leukemia, myeloma, or germ cell tumors
* Patients planning to undergo radiosurgery must meet the following criteria:
* Largest diameter ≤ 3.5 cm for single metastasis
* Largest diameter ≤ 2.5 cm for multiple metastases
* Stereotactic biopsy required if not extracranial tumor (unknown primary tumor) OR extracranial diagnosis made more than 4 years previously
* Prior neurosurgery patients must have undergone complete surgical resection
* No recurrent brain metastases after prior surgery and/or radiosurgery and/or brain radiotherapy
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* WHO 0-2 (may be assessed under steroid therapy)
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
* No concurrent chemotherapy during whole brain radiotherapy
Endocrine therapy
* See Disease Characteristics
Radiotherapy
* See Disease Characteristics
Surgery
* See Disease CharacteristicsReferences
Publications (5)
- RESULTKocher M, Soffietti R, Abacioglu U, Villa S, Fauchon F, Baumert BG, Fariselli L, Tzuk-Shina T, Kortmann RD, Carrie C, Ben Hassel M, Kouri M, Valeinis E, van den Berge D, Collette S, Collette L, Mueller RP. Adjuvant whole-brain radiotherapy versus observation after radiosurgery or surgical resection of one to three cerebral metastases: results of the EORTC 22952-26001 study. J Clin Oncol. 2011 Jan 10;29(2):134-41. doi: 10.1200/JCO.2010.30.1655. Epub 2010 Nov 1. PMID 21041710
- RESULTMekhail T, Sombeck M, Sollaccio R. Adjuvant whole-brain radiotherapy versus observation after radiosurgery or surgical resection of one to three cerebral metastases: results of the EORTC 22952-26001 study. Curr Oncol Rep. 2011 Aug;13(4):255-8. doi: 10.1007/s11912-011-0180-1. No abstract available. PMID 21584645
- DERIVEDChurilla TM, Chowdhury IH, Handorf E, Collette L, Collette S, Dong Y, Alexander BM, Kocher M, Soffietti R, Claus EB, Weiss SE. Comparison of Local Control of Brain Metastases With Stereotactic Radiosurgery vs Surgical Resection: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2019 Feb 1;5(2):243-247. doi: 10.1001/jamaoncol.2018.4610. PMID 30419088
- DERIVEDChurilla TM, Handorf E, Collette S, Collette L, Dong Y, Aizer AA, Kocher M, Soffietti R, Alexander BM, Weiss SE. Whole brain radiotherapy after stereotactic radiosurgery or surgical resection among patients with one to three brain metastases and favorable prognoses: a secondary analysis of EORTC 22952-26001. Ann Oncol. 2017 Oct 1;28(10):2588-2594. doi: 10.1093/annonc/mdx332. PMID 28961826
- DERIVEDSoffietti R, Kocher M, Abacioglu UM, Villa S, Fauchon F, Baumert BG, Fariselli L, Tzuk-Shina T, Kortmann RD, Carrie C, Ben Hassel M, Kouri M, Valeinis E, van den Berge D, Mueller RP, Tridello G, Collette L, Bottomley A. A European Organisation for Research and Treatment of Cancer phase III trial of adjuvant whole-brain radiotherapy versus observation in patients with one to three brain metastases from solid tumors after surgical resection or radiosurgery: quality-of-life results. J Clin Oncol. 2013 Jan 1;31(1):65-72. doi: 10.1200/JCO.2011.41.0639. Epub 2012 Dec 3.