Radiation Therapy With or Without Surgery in Treating Patients Who Have Brain Metastases

Metastatic Cancer Clinical Trial

Official title:

Prognostic Factors Associated With Successful Omission of Whole Brain Radiotherapy in Patients With 4 or Less Cerebral Metastases Treated With Focal Radiation or Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003324
• Other study ID #: CDR0000066275
• Secondary ID: UCLA-HSPC-971007
• Status: Completed
• Phase: N/A
• Start date: December 1997

Study information

• Verified date: July 2012
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells in a single high dose. Combining radiation therapy with surgery may be a more effective treatment for brain metastases.

PURPOSE: Clinical trial to study the effectiveness of radiation therapy with or without surgery in treating patients who have brain metastases.

Description:

OBJECTIVES:

• Develop prognostic factors for patients with brain metastases treated by focal treatment without concurrent whole brain irradiation.

• Determine whether focal treatment without whole brain radiotherapy produces good long-term outcome in patients with four or less cerebral metastases.

• Assess survival, physical and cognitive functioning, and quality of life of patients treated on this protocol.

OUTLINE: Quality of life is assessed using the FACT-BR scale, physical function is assessed using the FIM scale, and cognition is assessed using two brief pencil and paper tests.

Patients receive focal therapy for cerebral metastases by any combination of (1) surgery plus fractionated stereotactic radiotherapy to surgical bed, or (2) single fraction stereotactic radiotherapy by linear accelerator with or without a radiation sensitizer.

Patients are followed at 2 and 10 weeks, then every 3 months for 18 months, then every 6 months for 3 years, then annually. Quality of life is assessed at each followup visit.

Patients suffering intracerebral relapse are offered further focal therapy if they have no more than 3 metastases, no more than 6 lesions over consecutive scans, and continue to have life expectancy of at least 3 months and Karnofsky performance status of 60-100%. Otherwise, relapsed patients are offered whole brain radiotherapy or supportive treatment with steroids, and may also receive stereotactic boost to the new lesions. Patients who have received prior whole brain irradiation will be offered entry into other protocols if eligible or supportive treatment with steroids. Patients are followed as above.

PROJECTED ACCRUAL: At least 60 patients will be enrolled in this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Biopsy, CT scan, or MRI proven cerebral metastases with known current or previous systemic malignancy OR

• Biopsy proven cerebral metastases other than from small cell lung cancer or lymphoma

• Refused whole brain radiation therapy OR

• Received prior whole brain radiation therapy and ineligible for other relapse protocols

• 18 and over

• Karnofsky 60-100%

• Life expectancy:At least 3 months

• Concurrent steroids allowed

Exclusion Criteria:

• more than four cerebral metastases on MRI scan and suitable for focal treatment with surgery and/or stereotactic radiotherapy with a linear accelerator

• more than 2 weeks since prior focal radiation

• more than 2 weeks since prior focal surgery

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Procedure:
• conventional surgery

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Chitapanarux I, Goss B, Vongtama R, Frighetto L, De Salles A, Selch M, Duick M, Solberg T, Wallace R, Cabatan-Awang C, Ford J. Prospective study of stereotactic radiosurgery without whole brain radiotherapy in patients with four or less brain metastases: — View Citation