Adjuvant Radiation Therapy in Treating Patients With Brain Metastases - Full Text View

Sponsored by:	European Organization for Research and Treatment of Cancer
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002899

Purpose

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.

Condition	Intervention	Phase
Metastatic Cancer	Procedure: adjuvant therapy Radiation: radiation therapy Radiation: stereotactic radiosurgery	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	Phase III Trial on Convergent Beam Irradiation of Cerebral Metastases

Resource links provided by NLM:

MedlinePlus related topics: Cancer Radiation Therapy Surgery

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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 [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival as measured by Logrank at 8 weeks after completion of study treatment, and then every 3 months until death [ Designated as safety issue: No ]
Progression-free survival as measured by Logrank 8 weeks after completion of study treatment, and then every 3 months until death [ Designated as safety issue: No ]
Time to neurological progression as measured by Logrank 8 weeks after completion of study treatment, and then every 3 months until death [ Designated as safety issue: No ]
Acute toxicity as measured by EORTC and RTOG scale 8 weeks after completion of study treatment, and then every 3 months until death [ Designated as safety issue: Yes ]
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 [ Designated as safety issue: Yes ]
Quality of life as measured by QLQ-C30 and BN-25 8 weeks after completion of study treatment, and then every 3 months until death [ Designated as safety issue: No ]

Estimated Enrollment:	340
Study Start Date:	November 1996

Detailed Description:

OBJECTIVES:

Primary

Investigate the efficacy and toxicity of adjuvant whole brain radiotherapy after prior surgical resection or radiosurgery of 1 to 3 brain metastases from solid tumor in patients with good performance status and controlled systemic cancer.

Secondary

Determine overall survival and progression-free survival of patients treated on this protocol.
Determine time to neurologic progression in patients treated on this protocol.
Determine quality of life of patients treated on this protocol.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating center, number of brain metastases (single vs multiple), type of primary tumor (stable systemic cancer vs synchronous or unknown primary), WHO performance status (0-1 vs 2), and treatment (prior surgical resection vs planned radiosurgery).

Patients who have undergone complete surgical resection are randomized to 1 of 2 treatment arms within 4 weeks after surgery.

Arm I: Patients undergo adjuvant whole brain radiotherapy (WBRT).
Arm II: Patients do not receive adjuvant radiotherapy. Patients planning to undergo radiosurgery are randomized to 1 of 2 treatment arms.
Arm III: Patients undergo radiosurgery followed by adjuvant WBRT within 4 weeks after surgery.
Arm IV: Patients undergo radiosurgery alone. Quality of life is assessed at baseline, at 8 weeks, and then every 3 months thereafter.

After completion if study treatment, patients are followed at 8 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 340 patients (85 per treatment arm) will be accrued for this study within 3.5 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002899

Show 33 Study Locations

Sponsors and Collaborators

European Organization for Research and Treatment of Cancer

Investigators

Investigator:	Rolf-Peter Mueller, MD	Medizinische Universitaetsklinik I at the University of Cologne
Investigator:	Riccardo Soffietti, MD	Universita Degli Studi di Turin

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Mueller RP, Soffietti R, Abacioglu MU, et al.: Adjuvant whole-brain radiotherapy versus observation after radiosurgery or surgical resection of 1-3 cerebral metastases: results of the EORTC 22952-26001 study. [Abstract] J Clin Oncol 27 (Suppl 15): A-2008, 2009.

Study ID Numbers:	CDR0000065229, EORTC-22952, EORTC-26001
Study First Received:	November 1, 1999
Last Updated:	August 29, 2009
ClinicalTrials.gov Identifier:	NCT00002899 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

tumors metastatic to brain

Study placed in the following topic categories:

Immunologic Factors
Adjuvants, Immunologic
Neoplasm Metastasis

Additional relevant MeSH terms:

Neoplasms
Neoplastic Processes
Pathologic Processes
Immunologic Factors

Physiological Effects of Drugs
Adjuvants, Immunologic
Neoplasm Metastasis
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 02, 2009